EWG's 2010 Sunscreen Guide

EWG’s 2010 Sunscreen Guide The Bottom Line on Sunscreens

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Few sunscreens win green rating EWG’s fourth annual Sunscreen Guide gives low marks to the current crop of sunscreen products, with a few notable exceptions. EWG researchers recommend only 39 – 8 percent – of 500 beach and sport sunscreens for this season. The reason? A surge in exaggerated SPF claims above 50 and new disclosures about potentially hazardous ingredients, in particular recently developed government data linking the common sunscreen ingredient vitamin A to accelerated development of skin tumors and lesions.

Industry’s lackluster performance and the federal Food and Drug Administration’s failure to issue regulations for sunscreens lead EWG to warn consumers not to depend on any sunscreen for primary protection from the sun’s harmful ultraviolet rays. Hats, clothing and shade are still the most reliable sun protection. Products with high SPF ratings sell a false sense of security because most people using them stay out in the sun longer, still get burned (which increases risk of skin cancer) and subject their skin to large amounts of UVA radiation, the type of sunlight that does not burn but is believed responsible for considerable skin damage and cancer. High SPF products, which protect against sunburn, often provide very little protection against UVA radiation. Few people use enough sunscreen to benefit from the SPF protection promised on the label. Studies show that people typically use about a quarter of the recommended amount. Because sunscreen effectiveness drops off precipitously when under-applied, in everyday practice a product labeled SPF 100 actually performs like SPF 3.2, an SPF 30 rating equates to a 2.3 and SPF 15 translates to 2. Moreover, FDA scientists say SPF claims above 50 cannot be reliably substantiated. This year, new concerns have arisen about a form of vitamin A called retinyl palmitate, found in 41 percent of sunscreens. The FDA is investigating whether this compound may accelerate skin damage and elevate skin cancer risk when applied to skin exposed to sunlight. FDA data suggest that vitamin A may be photocarcinogenic, meaning that in the presence of the sun’s ultraviolet rays, the

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compound and skin undergo complex biochemical changes resulting in cancer. The evidence against vitamin A is far from conclusive, but as long as it is suspect, EWG recommends that consumers choose vitamin A-free sunscreens. EWG has again flagged products with oxybenzone, a hormone-disrupting compound which penetrates the skin and enters the bloodstream. Biomonitoring surveys conducted by the Centers for Disease Control have detected oxybenzone in the bodies of 97 percent of Americans tested. In all, EWG researchers assessed about 1,400 products with SPF, including beach and sports lotions, sprays and creams, moisturizers, make-up and lip balms. The 39 beach and sports products that earned EWG’s coveted “green” rating for safety and efficacy all contain the minerals zinc or titanium. We could find no non-mineral sunscreens that scored better than “yellow.” Some of the blame falls on the FDA, which has yet to finalize regulations for sunscreens promised since 1978. FDA officials estimate that the regulations may be issued next October – but even then, they expect to give manufacturers at least a year, and possibly longer, to comply with the new rules. That means the first federally regulated sunscreens won’t go on store shelves before the summer of 2012.

Sunscreen and skin cancer – the science The first sunscreens were developed to prevent severe sunburn for military personnel spending long hours under strong and direct sunlight (Maceachern 1964). Today, they are associated with a wide range of purported purposes, from reducing skin aging and direct sun damage to decreasing the risk of skin cancer. Yet expert opinions differ widely on the strength and reliability of scientific evidence that supports these claims (Autier 2009; Draelos 2010). The power of sunscreen to protect against sunburn is well known; this is the feature of sunscreens identified as the Sun Protection Factor or SPF. Yet, the wide availability of sunscreens has allowed people with light-color skin to stay outdoors longer, often aiming to get a tan or to maximize burn-free time in the sun (Autier 2009; Lautenschlager 2007). Expert’s recommendations to wear sunscreen are tempered. Skin cancer rates continue to increase in the U.S. and other countries. Studies do not provide evidence that sunscreen protects against the deadliest form of skin cancer, and scientists are not certain about which type of UV radiation, UVA or UVB, is most dangerous and therefore most important for sunscreen to block or absorb. Sobering statistics on skin cancer raise basic questions about sunscreen efficacy: • Even though more people use sunscreen than ever before, the incidence of skin cancer in the United States and other countries continues to rise (Aceituno-Madera 2010; Jemal 2008; Osterlind 1992).

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• A number of studies conducted in the 1990s report higher, not lower, incidence of the deadliest form of skin cancer, malignant melanoma, among frequent sunscreen users (Autier 1995; Westerdahl 2000; Wolf 1994). • According to the American Cancer Society, malignant melanoma accounts for only 3-4% of all skin cancer cases, but is responsible for 75% of all deaths attributed to the disease each year (ACS 2010) (See side-bar: “The 3 types of skin cancer”) • To date, studies show that regular sunscreen use reduces risk for squamous-cell carcinoma (SCC) but not other types of skin cancer. SCC, a slow-growing, treatable cancer, is estimated to account for just 16% of all skin cancers annually. •

The 3 types of skin cancer

Skin cancer is the most common cancer in the United States, accounting for nearly half of all cancer cases. One to 2 million people develop skin cancer each year (Bikle 2008; Rogers 2010, ACS 2010). A recent study estimated that the disease is five times more prevalent in the U.S. population than breast or prostate cancers (Stern 2010). Precise numbers for skin cancer incidence in the U.S. are not known, since non-melanoma skin cancer is usually excluded from cancer registry statistics and, additionally, their incidence varies by the geographical region (Rubin 2005). However, according to a review published by the American Cancer Society, among all the skin cancers 80% are basal-cell carcinoma (BCC), 16% are squamouscell carcinoma (SCC), and 4% are malignant melanomas, the deadliest form of skin cancer (Greenlee 2001).

Melanoma and sunscreen: UVA, UVB or both?

For decades, sunscreens available on the market primarily blocked UVB, the wavelength of ultraviolet radiation that causes sunburns (Draelos 2010). Sunscreen manufacturers and sunscreen users assumed that preventing or delaying sunburn would also protect from other dangerous effects of the sun such as skin cancer. Today, many experts believe that both UVA and UVB exposure may contribute to melanoma risk (Garland 2003; Godar 2009). Sunscreens produced over the past three decades that blocked UVB but allowed higher UVA exposure may not have been able to provide the necessary cancer protection (Draelos 2010) and may have contributed to risk of melanoma in some populations (Gorham 2007). Sunlight that reaches the surface of the Earth consists of longer-wavelength UVA (315–400 nm), shorter wavelength UVB (280–315 nm), visible light, and infrared light. UVB constitutes 3-5% of the total UV radiation that gets through the atmosphere, while UVA constitutes 95-97%. UVB, which only penetrates the outer skin layer, is the primary cause of sunburn (erythema or redness)

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and non-melanoma skin cancer such as squamous cell carcinoma (von Thaler 2010). In contrast, UVA can penetrate deeper into the skin where it causes a different type of DNA damage than does UVB (Cadet 2009). Even though many sunscreens now include UVA filters, a large number of products available in 2010 still fail to adequately protect sunscreen users from UVA radiation. A growing body of data points to UVA exposure as a significant factor in melanoma development. But scientists still do not know the relative importance of UVA and UVB in melanoma development (Donawho 1996; Setlow 1993), a knowledge gap that raises the importance of broad-spectrum protection in sunscreens, with filters that absorb both UVA and UVB radiation: • “Results from animal models, epidemiological studies, and clinical observations suggest that UVA might play an important role in the pathogenesis of malignant melanoma.” Rünger 1999, Photodermatology, photoimmunology & photomedicine. • “Collectively, [current] data suggest a potential role for UVA in the pathogenesis of melanoma.” Wang et al 2001, Journal of the American Academy of Dermatology. • “The issue of [melanoma] action spectrum has been a subject of debate, with some groups suggesting that the effect of UVA is predominant in human melanoma with earlier groups having suggested that UVB is the predominant cause of skin cancer in general, although not necessarily melanoma in particular.” Garland et al. 2003, Annals of Epidemiology. • “Although sunlight is known to cause melanoma, there has been considerable controversy as to the importance of short (UVB) and long (UVA) ultraviolet (UV) wavelengths in causing melanoma, leading to uncertainty in how best to prevent this cancer. This uncertainty has been compounded by the difficulties in assaying the UVA protection abilities of sunscreens, as compared to widely accepted measures of UVB screening by the sun protection factor (SPF).” Lund & Timmins 2007, Pharmacology and therapeutics. • “The [sunscreen’s] ability to prevent sunburns (as measured by SPF) probably does not imply the ability to prevent melanoma or basal cell carcinoma.” Autier 2009, British Journal of Dermatology. • “The specific contribution of UVB and UVA radiation exposure towards the risk of melanoma is controversial.” von Thaler et al. 2010, Experimental Dermatology. • “There is also sufficient evidence of an increased risk of ocular melanoma associated with the use of tanning devices.” International Agency for Research on Cancer (IARC) 2009. “Indoor tanning facilities in general deliver higher relative intensities and higher proportions of UVA compared with solar UV radiation.” IARC 2006.

Why don’t scientists know more about sunscreen and skin cancer?

Three factors preclude drawing definitive conclusions about the effects of sunscreens on skin cancer

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risk: 1) in parallel with protection from sunburns, application of sunscreens has been also associated with increased sun exposure, including usually unexposed sites such as the trunk (Autier 2000; Dupuy 2005; Stanton 2004); 2) early-generation sunscreens did not provide significant or adequate UVA protection or possibly even sufficient UVB protection (Diffey 2009; Lautenschlager 2007; Osterwalder 2009); 3) sunscreen use in the populations studied may not have been consistent or sufficient to provide the protection from melanoma (Bech-Thomsen 1992; Thieden 2005). Published studies have examined the correlation between sunscreen use and the development of the three most common forms of skin cancer: basal cell carcinoma, squamous cell carcinoma, and malignant melanoma. In 2000, International Agency for Research on Cancer (IARC) reviewed available data and concluded that: • Sunscreen use may decrease the occurrence of squamous cell carcinoma. • Sunscreen use has no demonstrated influence on basal cell carcinoma. • In intentional sun exposure situations, sunscreen use may increase the risk of melanoma (IARC 2001a; reviewed in Autier 2009). Studies conducted over the past decade have confirmed that regular sunscreen use lowers the risk of squamous cell carcinoma (Gordon 2009; van der Pols 2006), similar to studies completed in the 1990s (Green 1999). Regular sunscreen application also diminishes the incidence of solar keratosis (also known as actinic keratosis), a type of sun-induced skin changes that may become precursors to squamous cell carcinoma (Naylor 1995; Thompson 1993). For basal cell carcinoma, follow up studies reported a slight and not-statistically significant decrease in risk associated with sunscreen use (Pandeya 2005; van der Pols 2006). Thus, for this cancer type, data on sunscreen benefits remain negative or equivocal (Hunter 1990; Rosenstein 1999; Rubin 2005). However, from the public health perspective, physicians are most concerned about malignant melanoma, the deadliest type of skin cancer (Lund 2007; World Health Organization 2006). Sunburns are an important risk factor for melanoma (Leiter 2008). Intermittent, severe sunburns in childhood have been considered to pose the greatest risk, although sunburn during all life periods likely contributes to melanoma development (Autier 1998; Dennis 2008).

State of the evidence: human epidemiology studies of melanoma risk in sunscreen users

Individual studies provide conflicting evidence on the role of sunscreen in melanoma risk. Studies in Sweden, Belgium, France, Germany, Austria, and New York state report an elevated risk of melanoma in sunscreen users (Autier 1998; Beitner 1990; Graham 1985; Westerdahl 2000; Wolf 1998). In contrast, studies in Spain, Brazil and San Francisco, California report decreased risk of melanoma in sunscreen users (Bakos 2002; Espinosa Arranz 1999; Holly 1995; Rodenas 1996). A 2000 IARC assessment of 15 studies on sunscreen and melanoma revealed conflicting evidence

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regarding associations between sunscreen and melanoma, with 3 studies showing significantly lower risks on melanoma associated with sunscreen use, 8 studies finding significantly higher risks associated with sunscreen use, and 4 studies reporting no effect (IARC 2001, reviewed in Dennis 2003; Diffey 2009; Gorham 2007; Huncharek 2002). Some scientists have combined the data from multiple sunscreen studies in what are called “metaanalyses,” which allows them to assess larger or specialized groups of sunscreen users. A metaanalysis of melanoma studies conducted by University of Iowa scientists in 2003, reported a lack of overall association between melanoma risk and sunscreen use (Dennis 2003). The Iowa researchers suggested that findings of elevated risk in a large group of studies conducted in Europe and U.S. may have been due to confounding effects, such as differences in skin sensitivity to sunlight among people with lighter or darker skin. Sunscreens are more likely to be used by people most at risk of quick sunburn (Diffey 2009; Geller 2002), a group at higher risk for melanoma (Dubin 1986). In contrast to the conclusion from the Iowa group, a meta-analysis conducted by University of California San Diego scientists in 2007 found a link between the location of the study (high or low latitude from the equator) and the risk of melanoma in relationship to sunscreen use. According to this analysis, in populations living at latitudes below 40o from the equator, the use of sunscreens was associated with a non-significant decreased risk of melanoma, while populations in higher latitudes faced a statistically significant increase in melanoma risk linked with sunscreen use (Gorham 2007). Skin pigmentation may have been the reason for these latitude effects (Gorham 2007). Studies finding protective effects of sunscreens generally included Mediterranean populations or populations with prevalent Mediterranean ancestry, which have higher degree of constitutive pigmentation. On the other hand, studies conducted in light-skinned populations residing far from the equator (above 40o latitude) generally found a statistically significant 60 percent increase in melanoma risk (Espinosa Arranz 1999; Rodenas 1996). Experts generally agree that the tendency of sunscreen users to spend more recreational time in direct sunlight and to wear less protective clothing may increase the amount of sun damage that leads to melanoma (Autier 2009; Draelos 2010; Gorham 2007). Additionally, scientists still do not know which wavelengths of sunlight drive melanoma development (Donawho 1996). Thus, historical absence of broad-spectrum UV protection in sunscreen, especially UVA protection, may have contributed to melanoma development or at least to the lack of evidence for a decrease in melanoma risk (Garland 2003; Godar 2009). With so little known with confidence about sunscreen and skin cancer, it is no wonder that many experts are now recommending clothing and shade, not sunscreen, as primary barriers from sun exposure.

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Health agencies question sunscreen efficacy Most experts agree that people should use sunscreens to protect their skin from the sun, but they disagree widely on how well they actually work. Studies of frequent sunscreen users have shown reduced risks for squamous cell carcinoma, a slow-growing tumor that is readily treatable by surgery, compared to people who use sunscreen infrequently or not at all. But some research teams have found the opposite for the deadliest form of skin cancer, melanoma, concluding that sunscreen users are at increased risk. No one knows why. Some studies demonstrate that sunscreen users stay out in the sun longer and absorb more radiation overall. Scientists speculate that substances called free radicals, released in skin when sunscreen chemicals break down in sunlight, may also play a role. One other hunch: Inferior sunscreens with poor UVA protection, which have dominated the market for 30 years, may have driven this surprising outcome. The conflicting science has divided the experts, with some questioning whether sunscreens do anything to prevent skin cancer of any kind. Many experts agree on the lack of evidence that sunscreens protect against skin cancer: * “FDA is not aware of data demonstrating that sunscreen use alone helps prevent skin cancer.” – U.S. Food and Drug Administration (FDA) 2007 * “Sunscreens were never developed to prevent skin cancer. In fact, there is no evidence to recommend that sunscreens prevent skin cancer in humans.” — Zoe Diana Draelos, editor of Journal of Cosmetic Dermatology, 2010 As a result, there is differing advice on how best to protect oneself from the sun’s damaging radiation:

In defense of shade and clothing

The International Agency for Research on Cancer (IARC) is one of many public health agencies that recommend taking other measures before using sunscreens: * “Sunscreens should not be the first choice for skin cancer prevention and should not be used as the sole agent for protection against the sun” – IARC 2001 The agency’s experts have noted that people wearing sunscreens may be tempted to stay in the sun longer than is safe. They write: “The use of sunscreens can extend the duration of intentional sun exposure, such as sunbathing. Such an extension may increase the risk for cutaneous melanoma”

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(Vainio 2000). The agency advocates wearing protective clothing, seeking shade, timing outdoor play to avoid peak sun – and using sunscreen only then (IARC 2001). Zoe Diana Draelos, editor of the Journal of Cosmetic Dermatology, has hypothesized that sunscreens may not be as safe as dermatologists contend and should be used only on exposed areas, like the hands, that cannot easily be covered with tightly woven clothing. She notes that wearing clothing “over most of the body, with sunscreen only applied to exposed areas, such as face and hands, might minimize systemic levels and prevent problems, which as of yet are poorly understood” (Draelos 2010). Among these problems is the potential hormonal toxicity of sunscreen active ingredients (Draelos 2010; Janjua 2008; Soto 2005). Whole-body application of sunscreens would increase systemic absorption of these ingredients through the skin and the risk of adverse health effects.

In defense of sunscreen

Others experts have been more outspoken in defense of sunscreens. A recent article in the British Journal of Dermatology suggested that “despite the lack of evidence demonstrating the efficacy of modern sunscreens in preventing melanoma… it would be irresponsible not to encourage their use, along with other sun protection strategies, as a means of combating the year-on-year rise in melanoma incidence” (Diffey 2009). Similarly, the American Academy of Dermatology said in a 2009 statement: “To protect against skin cancer, a comprehensive photo-protective regimen, including the regular use and proper use of a broad-spectrum sunscreen, is recommended.”

In defense of neither sunscreens nor clothing

The National Cancer Institute has concluded that there is no evidence that covering the skin at all, whether with clothing or sunscreens, decreases the risk of skin cancer, a sobering finding: “It is not known if protecting skin from sunlight and other UV radiation decreases the risk of skin cancer. It is not known if non-melanoma skin cancer risk is decreased by staying out of the sun, using sunscreens, or wearing long sleeve shirts, long pants, sun hats and sunglasses when outdoors” (NCI 2009).

In defense of sunlight

Finally, many scientists have called attention to the benefits of sunlight and outdoor time to stimulate production of vitamin D, which the skin generates when exposed to sunlight, and to enhance overall well being (Fielding 2010; Lucas 2008). According to scientists at the Los Angeles County Department of Public Health, “avoiding sun exposure by staying indoors more may come at the cost of adequate physical activity. The consequences of overweight and obesity, cardiovascular disease, and, yes, potentially many non-skin types of cancer indicate that there are important trade-offs between messages to reduce sun exposure and messages to get regular sun exposure to

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stimulate the production of vitamin D and to get adequate physical exercise.” (Fielding 2010) A range of experts say vitamin D’s benefits should be considered in issuing recommendations for sun protection and sunscreen use (Grant 2009; Reichrath 2009; Tang 2010).

What’s wrong with high SPF?

Theoretically, applying SPF 100 sunscreen allows beachgoers to bare their skin to sunshine a hundred times longer before causing the skin to burn: Someone who would normally redden in 30 minutes could remain in the sun for 50 hours before a burn would appear. But for high-SPF sunscreens, theory and reality are two different things. Studies have found that users of high-SPF sunscreens have similar or even higher exposures to harmful ultraviolet (UV) rays than people relying on lower SPF products. The reason: People trust the product too much, go too long before reapplying it and stay out in the sun too long (Autier 2009). In 2007, the FDA published draft regulations that would prohibit companies from labeling sunscreens with an SPF (sun protection factor) higher than “SPF 50+.” The agency wrote that higher values would be “inherently misleading,” given that “there is no assurance that the specific values themselves are in fact truthful…” (FDA 2007). Since then FDA has been flooded with data from sunscreen makers seeking to win agency approval for high-SPF products, and store shelves have been increasingly packed with high-SPF products the agency has yet to validate. Johnson & Johnson (makers of Neutrogena and Aveeno sunscreens) submitted data in August 2008 to support SPF 70 and SPF 85 claims (J&J 2008). Playtex (Banana Boat sunscreen) sent data supporting high SPF claims in 2007. A Coppertone spokeswoman said, “Many manufacturers, including Coppertone, have submitted new data [on high-SPF products] for review and are awaiting FDA’s response” (Boyles 2009). High-SPF sunscreens are popular. Sales have been on the rise for at least a decade, so it’s no wonder that sunscreen makers are fighting to keep them legal. In a letter to FDA 10 years ago, Neutrogena cited consumers’ clear demand for high SPF products, calling them “one of the fastest growing segments” of the market (Neutrogena 2000). Between 2004 and 2008, sales of high-SPF products in Europe (SPF 40 and 50+) swelled from 15 percent to 20 percent of the market (Jones 2010). In 2010, sunscreen makers have once again increased their high-SPF offerings in the US. Nearly one in six products now lists SPF values higher than “SPF 50+”, compared to only one in eight the year before, according to EWG’s analysis of nearly 500 beach and sport sunscreens. Here’s what’s wrong with high-SPF sunscreens:

Extended sun exposure, same number of sunburns

Users of high-SPF sunscreens stay in the sun longer with a single application and get burned when the product’s chemicals break down, wash off or rub off on clothes and towels. Armed with a false sense of security, they extend their time in the sun well past the point when users of low-SPF products head indoors. As a result, they get the same number of sunburns as unprotected sunbathers and absorb more damaging UVA radiation, which many high-SPF products do not effectively block. People seeking “intentional sun exposure” are most at risk from high-SPF products. In contrast to landscapers, gardeners, baseball players and others who spend defined times outdoors for specific jobs (“nonintentional sun

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exposure”), people in the intentional exposure category intend to tan or otherwise expose large areas of bare skin to the sun for prolonged periods (Autier 2009). Studies of volunteers on summer vacation in France, Switzerland and Belgium found that those using high-SPF products extended their sunbathing time by 19-to-25 percent, used the same amount of sunscreen as those using low-SPF products, were likelier to start sunbathing at noon instead of the later hours chosen by the low-SPF users and got the same number of sunburns. From these studies it appears that by delaying sunburn, high-SPF products take away a key warning of UV overexposure. Sunbathers stay out longer and soak up more radiation, especially in the UVA range where sunscreens are relatively ineffective (Autier 2009).

Philippe Autier, a scientist at the International Agency for Research on Cancer, concluded that high-SPF products spur “profound changes in sun behavior” that may account for the increased melanoma risk found in some studies. He advises that people seeking sun exposure “should be advised not to use sunscreen but rather to let their skin adapt and set strict limits on the time they spend in the sun” (Autier 2009). Though his conclusion has not been adopted wholesale by public health agencies, it is grounded in a growing body of evidence that raises basic questions about the efficacy of sunscreen for sunbathers and others intentionally seeking sun exposure. Clothing is an effective alternative. One study found that melanoma risk was cut by 52 percent for parts of the body usually covered by clothing during summer outdoor work (Holman et al 1986). EWG believes that hats and shirts are the best sunscreen of all.

Increased exposure to potentially hazardous ingredients

High-SPF products contain greater amounts of sun-blocking chemicals than low-SPF sunscreens. These ingredients may pose health risks when they penetrate through the skin, where they have been linked to tissue damage and potential hormone disruption. If studies supported a reduction in skin damage and skin cancer risk from high-SPF products, the additional exposures might be justified. But they don’t, so choosing sunscreens with lower amounts of active ingredients – SPF 30 instead of SPF 70, for example – is prudent.

SPF factors are based on two-to-five times more sunscreen than people actually use

In the real world, people get far less protection than the bottle advertises. Sunscreen makers establish a product’s SPF by testing their products on volunteers. The testers coat the volunteers’ backs with 2 milligrams of sunscreen per square centimeter of skin (mg/cm2), the amount stipulated in FDA’s draft sunscreen regulations (FDA 2007), and then expose them to sunlight-simulating UV radiation until a burn appears. The time needed to burn, divided by the time it takes to burn the volunteers’ unprotected skin, is the SPF. In real life, people apply one-half to one-fifth the amount of sunscreen used in the laboratory SPF tests (Autier 2003, Azurdia 2001, Reich 2009). Because of the physics of sunlight, that cuts the

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protection factor not by a factor of just 2 to 5, but by between the square root and the fifth root of the SPF. That’s a much steeper “exponential” cut in protection (Faurschou 2007, Schalka 2009, Kim 2010, Playtex 2007). For example, this means that someone who applies one-fourth as much sunscreen as in the SPF test gets just SPF 2.3 protection from an SPF 30 product. SPF 100 becomes just SPF 3.2.

How under-application of sunscreen cuts effective SPF (based on applying one-fourth the recommended amounts) SPF on label 15 30 50

Average SPF of users at (0.5 mg/cm2)

% UV transmission (amount reaching skin)

2.3

43%

2

2.6

50% 38%

100 3.2 31% Source: EWG analysis of sunscreen efficacy based on a typical sunscreen application rate of one-fourth of 2 milligrams per square centimeter of skin (the SPF testing application amount). A number of studies have confirmed people’s tendency to apply less sunscreen than is used in SPF testing. One study of 124 students found that the average application rate was one-fifth (0.39 mg/cm2) the testing amount (Autier 2003). Another study found that ten female volunteers applied a median thickness of sunscreen that was one-fourth (0.5 mg/ cm2) the amount used in testing (Azurdia 2001). Even when researchers instructed volunteers on the proper amount to use, they applied too little: A study of 52 subjects found that uninstructed volunteers applied 34 percent of the recommended thickness, and even those who were instructed on how much to apply used only 43 percent of the recommended amount (Reich 2009). The fact that people use less sunscreen than recommended is not an argument for using even higher SPF products to compensate. Higher SPF products produce small increases in real-world SPF. But even this small change allows sunbathers to stay in the sun longer – and absorb more overall radiation – before a sunburn sends them indoors. In the process, the substantially greater amounts of sunscreen chemicals in higher SPF products can penetrate the skin and lead to much higher internal exposures to potentially hazardous compounds. The user is left with a burn and a significantly higher “body burden” of sunscreen chemicals.

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Getting enough vitamin D Vitamin D is essential for many processes in the body, including maintaining healthy bones and a strong immune system and protection from cancer. It is formed in the skin through the action of the sun (Adams 2010). In human epidemiological studies, low vitamin D levels have been associated with increased cardiovascular mortality, metabolic disease and susceptibility to infections. Yet over the last two decades, vitamin D levels in the U.S. population have been decreasing steadily, creating a growing epidemic of vitamin D insufficiency (Ginde 2009a). Seven of 10 children in the U.S. have low levels of vitamin D. Of those, nine percent have a serious deficiency and 61 percent have higher but still insufficient levels (Kumar 2009). Mirroring this national deficiency, 70 percent of breastfed babies are vitamin D deficient at 1 month of age (Wagner 2010), when such a deficiency can be particularly harmful because of vitamin D’s role in growth and development. Sunscreen use combined with too little outdoor time contributes to vitamin D deficiencies, but experts disagree on whether short amounts of time in the sun or supplements are the best way to help a person deficient in vitamin D.

The many roles of vitamin D

Vitamin D is a fat-soluble hormone essential for bone growth in children and for maintaining healthy bone mass in adults. Vitamin D precursors are produced in the skin through the effects of the sun, converted into the active form of vitamin D in the kidneys and carried by the blood to the rest of the body (Adams 2010). Vitamin D promotes intestinal calcium and phosphate absorption and calcium/phosphate release from the bone. Vitamin D deficiency is associated with rickets in children and osteoporosis in adults (Papandreou 2010). Vitamin D is also produced by immune system cells as part of the body’s defenses against disease. People with low vitamin D levels are more susceptible to upper respiratory tract and other infections (Ginde 2009b). In epidemiological studies, low vitamin D levels have been associated with increases in cardiovascular mortality, colon cancer mortality and breast cancer risk and tentatively linked to skin cancer, metabolic disease, hypertension and obesity (Adams 2010; Grant 2009; Tang 2010).

The role of sunshine in vitamin D production

Ultraviolet (UV) light-induced vitamin D production can be inhibited by deep skin pigmentation, indoor lifestyles, older age, strict sun avoidance and other factors (Lucas 2006). Data from the

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National Health and Nutrition Examination Survey (NHANES) conducted by the Centers for Disease Control and Prevention suggest that both increased use of sun protection and higher average body weight are associated with lower vitamin D levels (Looker 2008). However, UV light exposure, whether from the sun or from artificial tanning, is also the most important environmental risk factor for skin cancer (International Agency for Research on Cancer 2001b). Over the past several decades, the incidence of the three most common forms — basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and malignant melanoma (MM) — has been steadily rising in the United States and other countries (Aceituno-Madera 2010; Gloster 1996). Physicians and scientists around the world universally agree that sun protection is essential to prevent skin cancers and reduce their toll on human health and well-being as well as health care costs (Gordon 2009). Yet strict sun protection has also been shown to cause vitamin D deficiency (Norval 2009; Reichrath 2009). Expert opinions vary on the best way to address vitamin D deficiencies. The American Medical Association has recommended that everyone get 10 to 15 minutes of direct sun (without sunscreen) several times a week, an amount sufficient for adequate vitamin D production (AMA 2008, Brender 2005). The American Academy of Dermatology expressed a different opinion in its 2009 Position Statement that “there is no scientifically validated, safe threshold level of UV exposure from the sun that allows for maximal vitamin D synthesis without increasing skin cancer risk.” The Academy recommends increased intake of foods naturally rich in vitamin D, vitamin D-fortified foods and vitamin D supplements (AAD 2009). According to a 2006 World Health Organization (WHO) report, Solar Ultraviolet Radiation: Global Burden of Disease from Solar Ultraviolet Radiation, it is important to focus on reducing the disease burden due to both excessive and insufficient UV exposure (WHO 2006). Using the disabilityadjusted life year (DALY) as a metric, WHO experts estimated that excessive sun exposure caused the loss of approximately 1.5 million DALYs (0.1 percent of the total global burden of disease) and 60,000 premature deaths in the year 2000, with the greatest burden from UV-induced cortical cataracts and cutaneous malignant melanoma (WHO 2006). By comparison, the same group of scientists noted that a much larger annual disease burden of 3.3 billion DALYs worldwide would result from very low levels of UV radiation exposure due to disorders of the musculoskeletal system such as rickets and osteoporosis and possibly an increased risk of various autoimmune diseases and life-threatening cancers (Lucas 2008). Researchers concluded that “without high dietary (or supplemental) intake of vitamin D, some sun exposure is essential to avoid diseases of vitamin D insufficiency” (Lucas 2008). The Institute of Medicine (IOM) of the U.S. National Academies is currently conducting a study to develop updated recommendations for adequate vitamin D intake (IOM 2010). This update is expected to cause a reconsideration of vitamin D deficiency in the general population and possibly

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call for more frequent testing of vitamin D levels and vitamin D supplementation (American Medical Association 2009). Limited, appropriate sun exposure may also become more accepted as a step toward maintaining adequate vitamin D levels (Lucas 2006; Reichrath 2009).

New FDA data: Sunscreen additive may speed skin damage Recently available data from an FDA study indicate that a form of vitamin A, retinyl palmitate, when applied to the skin in the presence of sunlight, may speed the development of skin tumors and lesions (NTP 2009). This evidence is troubling because the sunscreen industry adds vitamin A to 41 percent of all sunscreens.

Source: EWG analysis of data from FDA photocarcinogenicity study of retinyl palmitate (NTP 2009). Percent decreases in time to development of a significant tumor or lesion (for animals exposed to cream laced with retinyl palmitate) are relative to that for animals exposed to cream free of the compound.

The industry includes it in its formulations because it is an antioxidant that slows skin aging. That may be true for lotions and night creams used indoors, but FDA recently conducted a study of

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vitamin A’s photocarcinogenic properties, meaning the possibility that it results in cancerous tumors when used on skin exposed to sunlight. Scientists have known for some time that retinyl palmitate can spur excess skin growth (hyperplasia), and that in sunlight it can form free radicals that damage DNA (NTP 2000). In FDA’s 1-year study, tumors and lesions developed up to 21 percent sooner in lab animals coated in a vitamin A-laced cream (at concentrations of 0.1% to 0.5%) than in control animals treated with a vitamin-free cream. Both groups were exposed to the equivalent of nine minutes of noontime Florida sunlight each day for up to a year. The lowest level of vitamin A tested, 0.1%, accelerated tumor and lesion development by 11-13 percent compared to control animals. This amount is 50 times lower than the highest level of vitamin A deemed safe in personal care products (5 percent), as determined by the industry’s expert review panel in 2009 (the Cosmetic Ingredient Review panel, funded by the Personal Care Products Council trade association) (CIR 2009). The FDA data are preliminary; the agency will publish its evaluation and conclusions in a report expected in October 2010. If the data hold up in FDA’s final assessment, they suggest that some sunscreens may increase the risk of skin cancer. In the meantime, EWG recommends that consumers avoid sunscreen with vitamin A (look for “retinyl palmitate” or “retinol” on the label).

New data supports long-standing FDA concerns about the safety of vitamin A The FDA’s National Center for Toxicological Research (NCTR) and the National Toxicology Program (NTP) recently posted on the NTP website data from FDA’s long-term photocarcinogenicity tests of retinyl palmitate on UV-exposed laboratory animals. In the studies, animals treated with 0.1% and 0.5% retinyl palmitate (a form of vitamin A) developed skin tumors or lesions that grew significantly faster than mice treated with vitamin-free cream (NTP 2009). FDA and NTP will publish their final assessment after they complete a full analysis and peer review of the data, with publication estimated for December 2010 (Howard 2010). EWG scientists independently assessed the data while the protracted government review proceeds. EWG’s assessment strongly suggests that upon exposure to UV light, retinyl palmitate acts as a photocarcinogen and hastens the development of skin tumors and lesions. These results are in complete agreement with a large, existing body of research that includes several lines of evidence: • FDA scientists have shown that UV-exposed retinyl palmitate forms free radicals and causes

EWG’s 2010 Sunscreen Guide 15

DNA mutations (Cherng 2005; Mei 2006; Yan 2005). • Studies since the 1970s have reported that a closely related compound, retinoic acid, enhances UV-induced photocarcinogenicity in animal studies (Halliday 2000; NTP 2000). • Finally, in studies with human volunteers, retinol and retinyl palmitate (which converts to retinol after it absorbs through the skin) induced skin hyperplasia (Duell 1997), which is one of the effects found in the FDA photocarcinogenicity study. As is well known, vitamin A (retinol or its modified form, retinyl palmitate) is an essential nutrient required for good health. Vitamin A and its derivatives have also become very popular cosmetics ingredients that are promoted as providing a variety of benefits, from slowing skin aging and preventing oxidative stress from free radicals to renewing skin cells and filtering UV rays (Sorg 2006). Despite the purported benefits of vitamin A for the skin, for more than a decade the FDA has been concerned about its safety. The agency noted in 2000 that “cosmetic products containing retinyl palmitate are being marketed aggressively for rejuvenation of the skin” (NTP 2000), even though the safety of these ingredients in cosmetics had never been adequately demonstrated. In 2001 the agency called for extended phototoxicity and photocarcinogenicity studies of retinyl palmitate (Fu 2002). In 2008 FDA researchers expressed additional concerns over the widespread use of vitamin A-based ingredients in products used by women of childbearing age. In excessive doses retinol acts as teratogen (a compound that causes birth defects). FDA scientists found that a woman’s dose of vitamin A from using creams could exceed safe levels: “Total body application of a formulation with a high retinol concentration may result in retinol systemic absorption that exceeds certain recommended daily limits for women of child-bearing age” (Yourick 2008).

FDA’s photocarcinogenicity study of retinyl palmitate (RP)

The publicly available data from FDA’s new study suggest that when used in sun-exposed skin care products, retinyl palmitate and related chemicals may increase skin damage and elevate skin cancer risk instead of protecting the skin. EWG analyzed the FDA data and determined that even the lowest concentration of retinyl palmitate tested (0.1%), was associated with increased growth rates of skin tumors and lesions (NTP 2009). The one-year study involved a hairless mouse strain (SKH-1), a well-recognized model for photocarcinogenicity research (Bucher 2002; FDA 2009; Halliday 2000; Yan 2007). Both male and female animals were used, with 34-36 animals per group. Testing included two concentrations of retinyl palmitate, 0.1% and 0.5%, administered topically in a cream vehicle.

16 | Environmental Working Group

Animals were exposed to solar simulated light (SSL) with UVA/UVB ratio of 20.5:1, close to the proportion of UVB in sunlight of 3-to-5 percent, depending on latitude (Garland 2003). The animals were treated with cream and RP in the morning and received four hours of UV exposure in the afternoon. Two levels of light intensity were tested, 6.75 and 13.7 mJ CIE/cm2, equivalent to 0.3 and 0.6 of a minimal erythemal (sunburn) dose (MED). One MED is a common unit of sun exposure, equivalent to the time it takes to cause a sunburn that persists for 24 hours. According to an FDA publication, 0.6 MED is equivalent to nine minutes of unprotected UV exposure to high intensity UV light (UV index of 10) (Yan 2007). EWG analyzed the effect of the vitamin A dose on the length of time each animal remained in the study. Most were withdrawn and sacrificed when at least one skin tumor or lesion reached a significant, defined size. Though FDA did not publish the size at sacrifice for this study, in similar FDA photocarcinogenicity studies scientists sacrificed animals when tumors or lesions reached 5 to 10 millimeters in diameter (NTP 2007, 2008). Some animals may have been withdrawn before tumors and lesions reached that size if skin lesions began to merge (which would make it difficult to assess skin effects), or if the animals were otherwise ill. The reason for withdrawal is not available in the public data, so EWG was unable to distinguish between animals withdrawn because of large tumors, large lesions, or other reasons. The data show that at least 89 percent of vitamin-A exposed animals developed one or more tumors during the study, and large tumors were likely a significant reason for withdrawals. The hairless mouse is highly susceptible to skin cancer, tumors and lesions under the conditions of this test. As a result, the speed at which these types of skin damage develop is an accepted indicator of harm (NTP 2007, NTP 2008). EWG analyzed differences in the number of days recorded for each animal’s survival, a proxy for rate of tumor or lesion development. Animals treated with retinyl palmitate were withdrawn from the study 11-to-21 percent sooner than animals whose skin was treated with a neutral cream and exposed to the same doses of UV. These findings were statistically significant for both sexes and for each exposure group. Mice treated with only UV or only neutral cream combined with UV survived longer than animals exposed to vitamin A.

EWG’s 2010 Sunscreen Guide 17

Source: EWG analysis of published data from FDA photocarcinogenicity study of retinyl palmitate (NTP 2009).

These findings are preliminary. The data will be analyzed in detail by the FDA and NTP research team in a report due in the fall of 2010. In the interim, however, EWG is concerned that sunscreens incorporating vitamin A may be harmful. EWG cautions consumers to select sun products free of the compound until more conclusive information is available. This caution extends to other forms of vitamin A as well – retinol, retinyl acetate, and other retinyls – which are expected to display common toxic properties and to pose similar safety concerns (NTP 2000).

Significantly shorter time to tumor or lesion formation (p=80.0%

>=75.0%

>=68.8%

>=60.0%

90%

>66%

>33%

>29%

>25%

>21%

>16%

>14%

>11%

100 nm, particles >100 when dispersed in ester

Aluminum hydroxide and sillica

Kobo 2009

Kobo Products

MPT-154-NJE8

At least one dimension >100 nm

Alumina and jojoba esters

Kobo 2009

Kobo Products

TTO-NJE8

At least one dimension >100 nm

Alumina and jojoba esters

Kobo 2009

Sachtleben

Hombitec L5

est. 15 nm (80-160 m2/g)

Silica, Silicone

Schlossman 2005

Showa Denka

Maxlight TS-04

35 nm

Silica

Schlossman 2005

Tayca

MT-100T

Rutile

15 nm

AS/AH

SCCP 2000

Tayca

MT-500B

Rutile

35 nm

Alumina

Schlossman 2005

Tayca

MT-100Z

Rutile

15 nm

AS/AH

Schlossman 2005

Titan Kogyo

Stt 65C-S

Anatase

est. 20 nm (64 m2/g)

None

Schlossman 2005

Anatase

Zinc Oxide Suppliers and Products Supplier

Product

Primary particle size

Surface coating

Source

Antria/Dow

Zinclear

25 nm, >1 um when dispersed

Stearic acid

Schlossman 2005, Americhol 2009

BASF

Z-Cote

80 nm (30 to 200 nm)

uncoated or dimethicone

BASF 2006

Elementis

Nanox 200

60 nm (17 m2/g)

None

Schlossman 2005

ZnO-C-12

At least one dimension >100 nm

Isopropyl Titanium Triisostearate

Kobo 2009

Kobo Products

42 | Environmental Working Group

Kobo Products

ZnO-C-11S4

At least one dimension >100 nm

Triethoxycaprylysilane

Kobo 2009

Kobo Products

ZnO-C-NJE3

At least one dimension >100 nm

Jojoba esters

Kobo 2009

Kobo Products

ZnO-C-DMC2

At least one dimension >100 nm

Diemethicone/Methicone Copolymer

Kobo 2009

Sakai

Finex, SF-20

60 nm (20 m2/g)

None

Schlossman 2005

Showa Denka

ZS-032

31 nm

Silica

Schlossman 2005

Sumitomo Cement

ZnO-350

35 nm

None

Schlossman 2005

Tayca

MZ-700

10-20 nm

None

Schlossman 2005

Tayca

MZ-500

20-30 nm

None

Schlossman 2005

Tayca

MZ-300

30-40 nm

None

Schlossman 2005

Safety Assessment (Hazard Score) EWG’s health hazard scores were based upon the ingredient health hazard scoring system from our Skin Deep database (www.cosmeticdatabase.com). This core database of chemical hazards, regulatory status, and study availability pools the data of nearly 60 databases and sources from government agencies, industry panels, academic institutions, or other credible bodies. The information in Skin Deep is used to create hazard ratings and data gap ratings for personal care products, as well as for individual ingredients. We have given additional weight in our calculated hazard scores for properties of particular concern for sunscreens, including for products that contain oxybenzone or vitamin A, products in a spray or powder form that may pose risk when inhaled, and products listing SPF values exceeding “SPF 50+,” the limit proposed by FDA in their 2007 draft sunscreen rule (FDA 2007). For sunscreens with a single significant concern, we assigned a rating of no lower than 3 (moderate hazard), and for sunscreens with two or more significant concerns, we assigned a rating of no lower than 7 to reflect a higher level of concern for these products. Health hazard scores in our sunscreen evaluations reflect hazards specific to sunscreens, as well as beneficial or potentially harmful effects of specific combinations of active ingredients. We assessed hazards identified by government, industry, and academic sources, and did not evaluate specific claims made by individual manufacturers. This report includes a closer look at the 17 chemicals permitted by FDA for use as active ingredients in sunscreen (including the various sizes of inorganic sunscreens), and the 52 chemicals used in other countries to prevent UV exposure and added to U.S. sunscreens for another purpose. We compiled relevant information from sources that included published reports in the peer-reviewed literature and risk assessments from the European Union, Japan, and Australia, countries with robust sunscreen regulations.

EWG’s 2010 Sunscreen Guide 43

Assessing known or suspected chemical hazards Sunscreens sold in the U.S. are considered over-the-counter (OTC) drug products. They contain active ingredients that must undergo safety and effectiveness testing and inactive ingredients that, like virtually all other personal care product ingredients, are not required to be tested for safety before they are sold. We used different approaches to evaluate active and inactive ingredients. Active ingredient assessments, as well as assessments of specific active ingredient combinations, were evaluated by conducting an extensive review of the scientific literature. The review included peer-reviewed literature, filed and approved patents, and reviews by government and industry panels, as well as cross-checks with the existing Skin Deep databases. Certain inactive ingredients, such as those that are approved as active ingredients outside the U.S., are also treated as active ingredients for the health and sun hazard reviews. Inactive ingredient assessments were conducted using the existing Skin Deep system mentioned above (EWG 2007). Skin Deep identifies chemicals with health hazards including known and probable carcinogens, reproductive and developmental toxicants, neurotoxic and immunotoxic chemicals, chemicals flagged for their persistence, bioaccumulation, and toxicity, and chemicals banned or restricted in other countries. Skin Deep assessments also highlight the extensive data gaps for the majority of ingredients used in cosmetics and personal care products. Briefly, hazard ratings are a synthesis of known and suspected hazards associated with ingredients and products. Hazard ratings within Skin Deep are shown as low, moderate, or higher concern categories, with numeric rankings spanning those categories that range from 0 (low concern) to 10 (higher concern). Data gap ratings describe the extent to which ingredients or products have been definitively assessed for their safety. Data gap ratings are represented within Skin Deep by a numeric percentage ranging from 100% (complete absence of safety data) to 0% (comprehensive safety data). Further details concerning this methodology may be found on the Skin Deep website (www. cosmeticsdatabase.com).

References AAD. 2002. AAD Sunscreen Monograph Letter. (Lim HW, ed). Washington, DC: American Academy of Dermatology Association. Agin PP, Cole CA, Corbett C, Sanzare CM, Marenus K, Tedeschi JP, et al. 2005. Balancing UV-A and UV-B Protection in Sunscreen Products: Proportionality, Quantitative Measurement of Efficacy, and Clear Communication to Consumers. In: Sunscreens: Regulations and Comericial Development (Shaath NA, ed). New York: Taylor and Francis, 807 – 25.

44 | Environmental Working Group

Anders A, Altheide HJ, Knalmann M, Tronnier H. 1995. Action spectrum for erythema in humans investigated with dye lasers. Photochem Photobiol 61(2): 200-5. BASF 2000. Z-Cote microfine zinc oxide Available: http://www.solsunguard.com/zcote_brochure. pdf [accessed 5/15/2010] BASF 2009. Technical Information UV filters. BASF The Chemical Company. Available: http:// www.personal-care.basf.com/pdf/Statements/Technical%20Informations/EN/Cosmetic%20 Ingredients/04_050103e_UV%20filters.pdf [accessed May 17, 2010]. BASF 2010. Z-COTE Grades – Statement on Particle Size Distribution and Safety. 3/30/2010. Beeby A, Jones AE. 2000. The photophysical properties of menthyl anthranilate: A UV-A sunscreen. Photochemistry and Photobiology 72(1): 10-15. Berset G, Gonzenbach H, Christ R, Martin R, Deflandre A, Mascotte R, et al. 1996. Proposed protocol for determination of photostability. Part I: Cosmetic UV-Filters. Int J Cosmet Sci 18: 16777. Bonda CA. 2005. The Photostability of Organic Sunscreen Actives: A Review. In: Sunscreens: Regulations and Commercial Development, 3rd edition (Shaath NA, ed). Boca Raton, FL: Taylor & Francis. Cantrell A, McGarvey D, Mulroy L, Truscott T. 1999. Laser flash photolysis studies of the UVA sunscreen Mexoryl SX. Photochem Photobiol 70: 292-97. Chatelain E, Gabard B. 2001. Photostabilization of butyl methoxydibenzoylmethane (Avobenzone) and ethylhexyl methoxycinnamate by bis-ethylhexyloxyphenol methoxyphenyl triazine (Tinosorb S), a new UV broadband filter. Photochemistry and Photobiology 74(3): 401-06. CIR. 2006. 2006 CIR Compendium. Washington: Cosmetic Ingredient Review. Cole CA, Forbes, P.D. 1986. An action spectrum for UV photocarcinogenesis. Photochem Photobiol 43(3): 275-84. Cross SE, Innes B, Roberts MS, Tsuzuki T, Robertson TA, McCormick P. 2007. Human Skin Penetration of Sunscreen Nanoparticles: In-vitro Assessment of a Novel Micronized Zinc Oxide Formulation. Skin Pharmacol Physiol 20(3): 148-154. CTFA/NDMA. 1996. CTFA/NDMA Taskforce Report on Critical Wavelength Determination for the Evaluation of of the UVA Efficacy of Sunscreen Products: Cosmetics, Toiletry, and Fragrance Association. Damiani E, Baschong W, Greci L. 2007. UV-Filter combinations under UV-A exposure: Concomitant quantification of over-all spectral stability and molecular integrity. J Photochem Photobiol B 87(2): 95-104. Deflandre A, Lang G. 1988. Photostability assessment of sunscreens: benzylidene camphor and dibenzoylmethane derivatives. Int J Cosmet Sci 10: 53-62. Diffey, B. 2009. Spectral uniformity: a new index of broad spectrum (UVA) protection. International Journal of Cosmetic Science 31(1): 63-68. EWG. 2007. Skin Deep. Available: http://www.ewg.org/reports/skindeep [accessed June 7 2007]. EWG. 2010. Unpublished test results. FDA. 1999. Final Rule for Sunscreen Drug Products for Over-the-Counter Human Use. Federal

EWG’s 2010 Sunscreen Guide 45

Register: U. S. Food and Drug Administration, 27666. Ferrero L, Pissavini M, Marguerie S,  Zastrow L. 2003. Efficiency of a continuous height distribution model of sunscreen film geometry to predict a realistic sun protection factor. J. Cosmet. Sci. 54; 463 – 481. FOE. 2009. Nanotechnology and Sunscreens: A Consumer Guide for Avoiding Nano-Sunscreens. Friends of the Earth http://www.foe.org/healthy-people/nanotechnology-and-sunscreens, last updated 3/20/09. Gasparro F. 1997. Sunscreen Photobiology: Molecular, Cellular, and Physiological Aspects. New York: Springer. Gontier E, Habchi C, Pouthier T, Aguer P, Barberet P, Barbotteau Y, et al. 2004. Nuclear microscopy and electron microscopy studies of percutaneous penetration of nanoparticles in mammalian skin. 34th EDSR meeting Abstract 64. Gottbrath S, Muller-Goymann CC. 2003. Penetration and visualization of titanium dioxide microparticles in human stratum corneum – effect of different formulations on the penetration of titanium dioxide. SÖFW Journal 129(3): 11-17. Herzog B. 2002. Prediction of sun protection factors by calculation of transmissions with a calibrated step film model. Journal of Cosmetic Science 53(1): 11-26. Herzog B. 2005. Prediction of Sun Protection Factors and UV-A Parameters. In: Sunscreens: Regulations and Commercial Development (Shaath NA, ed). New York: Taylor and Francis Group, 954. Herzog B. 2006. Ciba Sunscreen Simulator. Available: http://www.cibasc.com/ pccibasunscreensimulator [accessed July 20 2006]. Herzog B, Hueglin D, Osterwalder U. 2005. New Sunscreen Actives. In: Sunscreens: Regulations and Commercial Development, 3rd edition (Shaath NA, ed). Boca Raton, FL: Taylor & Francis. Herzog B, Mongiat S, Dehayes C, Neuhaus M, Sommer K, Mantler A. 2002. In vivo and in vitro assessment of UVA protection by sunscreen formulations containing either butyl methoxy dibenzoyl methane, methylene bis-benzotriazoyl tetramethybutylphenol, or microfine ZnO. Int J Cosmet Sci 24: 170-85. Inbaraj J, Bilski P, Chignell C. 2002. Photophysical and photochemical studies of 2-phenylbenzimadazole and UVB sunscreen 2-phenylbenzimidazole-5-sulfonic acid. Photochem Photobiol 75(2): 107-16. Klein K, Palefsky I. 2005. Formulating Sunscreen Products. In: Sunscreens: Regulations and Commercial Development, 3rd edition (Shaath NA, ed). Boca Raton, FL: Taylor & Francis. Krishnan R, Carr A, Blair E, Nordlund T. 2004. Optical spectroscopy of hydrophobic sunscreen molecules absorbed to dielectric nanospheres. Photochemistry and Photobiology 79(6): 531-39. Menzel F, Reinert T, Vogt J, Butz T. 2004. Investigations of percutaneous uptake of ultrafine TiO2 particles at the high energy ion nanoprobe LIPSION. Nuclear Instruments & Methods in Physics Research Section B-Beam Interactions with Materials and Atoms 220: 82-86. McKinlay A, Diffey B. 1987. A reference action spectrum for ultraviolet-induced erythema in human skin. CIE Journal(6): 17-22.

46 | Environmental Working Group

Nanox 2009. Nanox 200 Series. Elementis Specialties. Available: http://www.essentialingredients. com/pdf/NANOX%20200%20Brochure.pdf [accessed May 17 2010]. Nohynek GJ, Lademann J, Ribaud C, Roberts MS. 2007. Grey goo on the skin? Nanotechnology, cosmetic and sunscreen safety. Crit Rev Toxicol 37(3): 251-277. Oneill JJ. 1984. Effect of Film Irregularities on Sunscreen Efficacy. Journal of Pharmaceutical Sciences 73(7): 888-91. Roscher N, Lindemann M, Kong S, Cho C, Jiang P. 1994. Photodecomposition of several compounds commonly used as sunscreen agents. J Photochem Photobiol A 80: 417-21. Sánchez C, Cuesta J. 2005. Materias Primas de Perfumería y de Cosmética. Filtros solares. Available: http://www.abacovital.com/fichastecnicas/filtros/filtros.htm [accessed June 20 2006]. Schlossman D, Shao Y, 2005. Inorganic Ultraviolet Filters In: Sunscreens: Regulations and Commercial Development (Shaath NA, ed). New York: Taylor and Francis Group, 251-253. Schwack W, Rudolph T. 1995. Photochemistry of dibenzoyl methane UVA filters part I. J Photochem Photobiol B Biol 28: 229-34. Serpone N, Salinaro A, Emeline AV, Horikoshi S, Hidaka H, Zhao JC. 2002. An in vitro systematic spectroscopic examination of the photostabilities of a random set of commercial sunscreen lotions and their chemical UVB/UVA active agents. Photochemical & Photobiological Sciences 1(12): 97081. Shaath N, Fares H, Klein K. 1990. Photodegradation of sunscreen chemicals: solvent considerations. Cosmet Toilet 105: 41-44. Shaath NA. 2005. Sunscreen Evolution. In: Sunscreens: Regulation and Commercial Development, 3rd edition (Shaath NA, ed). Boca Raton, FL: Taylor & Francis. Stamatakis P, Palmer B, Salzman G, Bohren C, Allen T. 1990. Optimum particle size of titanium dioxide and zinc oxide for attenuation of ultraviolet radiation. J Coating Technol 62(789): 95. Stanfield JW. 2005. In Vitro Techniques in Sunscreen Development. In: Sunscreens: Regulations and Comericial Development (Shaath NA, ed). New York: Taylor and Francis, 807 – 25. Steinberg DC. 2005. Regulation of Sunscreens Worldwide. In: Sunscreens: Regulations and Commercial Development, 3rd edition (Shaath NA, ed). Boca Raton, FL: Taylor & Francis. Turner P, Team GD, Stambulchik E. 2004. xmGrace Modeling Software. Vanquerp V, Rodriguez C, Coiffard C, Coiffard L, De Roeck-Holtzhauer Y. 1999. High-performance liquid chromatographic method for the comparison of the photostability of five sunscreen agents. J Chromatogr A 832: 273-77.

References

AAD (American Academy of Dermatology). 2009. Position Statement on Broad Spectrum Protection of Sunscreen Products. (Amended by the Board of Directors November 14, 2009) Available: http://web1.neton-line.com/forms/ policies/Uploads/PS/PS-Broad-Spectrum%20Protection%20of%20Sunscreen%20Products%2011-16-09.pdf AAD (American Academy of Dermatology). 2009. Position Statement on Vitamin D (Approved by the Board of Directors November 1, 2008) (Amended by the Board of Directors June 19, 2009). Available: www.aad.org/forms/ policies/uploads/ps/ps-vitamin%20d.pdf [accessed April 6 2010]. Aceituno-Madera P, Buendia-Eisman A, Arias-Santiago S, Serrano-Ortega S. Changes in the incidence of skin cancer

EWG’s 2010 Sunscreen Guide 47

between 1978 and 2002. 2010. Actas Dermosifiliogr 101(1): 39-46.

ACS (American Cancer Society). 2010. Skin cancer facts. Accessed May 12, 2010 at http://www. cancer.org/docroot/PED/content/ped_7_1_What_You_Need_To_Know_About_Skin_Cancer. asp. Adams JS, Hewison M. 2010. Update in vitamin D. J Clin Endocrinol Metab 95(2): 471-8. Adams LK, Lyon DY, Alvarez PJ. 2006. Comparative eco-toxicity of nanoscale TiO2, SiO2, and ZnO water suspensions. Water Research 40(19):3527-3532 Adams LK, Lyon DY, McIntosh A, Alvarez PJ. 2006. Comparative toxicity of nano-scale TiO2, SiO2 and ZnO water suspensions. Water Sci Technol 54(11-12): 327-34. Agin PP, Cole CA, Corbett C, Sanzare CM, Marenus K, Tedeschi JP, et al. 2005. Balancing UV-A and UV-B Protection in Sunscreen Products: Proportionality, Quantitative Measurement of Efficacy, and Clear Communication to Consumers. In: Sunscreens: Regulations and Comericial Development (Shaath NA, ed). New York: Taylor and Francis, 807 – 25. Allen JM, Gossett CJ, Allen SK. 1996. Photochemical formation of singlet molecular oxygen in illuminated aqueous solutions of several commercially available sunscreen active ingredients. Chemical Research in Toxicology 9(3): 605-609 AMA (American Medical Association). 2008. American Medical Association Complete Guide to Prevention and Wellness. John Wiley & Sons, Inc. Hoboken, NJ. Americhol. 2009. ZinCler IM Zinc Oxide Dispersions. Available at: http://www.dow.com/suncare/ literature/index.htm Anders A, Altheide HJ, Knalmann M, Tronnier H. 1995. Action spectrum for erythema in humans investigated with dye lasers. Photochem Photobiol 61(2): 200-5. AP (Associated Press). 2006. Sunscreen makers sued for misleading claims; popular brands exaggerate their effectiveness, nine lawsuits charge. Associated Press April 24, 2006. Ashby J, Tinwell H, Plautz J, Twomey K, Lefevre PA. 2001. Lack of binding to isolated estrogen or androgen receptors, and inactivity in the immature rat uterotrophic assay, of the ultraviolet sunscreen filters Tinosorb M-active and Tinosorb S. Regul Toxicol Pharmacol 34, (3), 287-91. ASTM. 2006. E 2456-06. Standard Terminology Relating to Nanotechnology, ASTM International, December 2006. http://www.astm.org/Standards/E2456.htm Autier P, Dore JF, Schifflers E, Cesarini JP, Bollaerts A, Koelmel KF, et al. 1995. Melanoma and use of sunscreens: an EORTC case-control study in Germany, Belgium and France. The EORTC Melanoma Cooperative Group. Int J Cancer 61:749-55. Autier P, Dore JF. 1998. Influence of sun exposures during childhood and during adulthood on melanoma risk. EPIMEL and EORTC Melanoma Cooperative Group. European Organisation for Research and Treatment of Cancer. Int J Cancer 77:533-7. Autier P, Dore JF, Reis AC, Grivegnee A, Ollivaud L, Truchetet F, et al. 2000. Sunscreen use and intentional exposure to ultraviolet A and B radiation: a double blind randomized trial using personal dosimeters. Br J Cancer 83(9): 1243-8. Autier P, Boniol M, Severi G, Dore J-F. 2003. Quantity of sunscreen used by European students. British Journal of Dermatology 144(2): 288-291.

48 | Environmental Working Group

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