Sunscreen Summary — What Works and What's Safe

In a new investigation of 1,022 name-brand sunscreens, the Environmental Working Group (EWG) found widespread evidence that many products on the market are not safe and effective, including one of every eight high-SPF sunscreens that does not protect from UVA radiation. We have also identified 147 products that offer very good sun protection with ingredients that present minimal health risks to users. Find out which in our best and worst lists.

More Americans than ever are using sunscreen to protect from sunburn and guard against skin cancer. Top choices include products with high SPF ratings, and that are waterproof or that advertise "broad spectrum" protection. Most people trust that the claims on the bottle will ensure that the product truly protects their health and their families'. Nothing could be less certain.

• Our comprehensive scientific review indicates that 86% of 1,022 sunscreen products offer inadequate protection from the sun, or contain ingredients with significant safety concerns. Only 14% of the products on the market are both safe and effective, blocking both UVA and UVB radiation, remaining stable in sunlight, and containing few if any ingredients with significant known or suspected health hazards. Our assessment is based on a review of nearly 400 scientific studies, industry models of sunscreen efficacy, and toxicity and regulatory information housed in nearly 60 government, academic, and industry databases.
• Many products lack UVA protection. Fully 12% of high SPF sunscreens (SPF of at least 30) protect only from sunburn (UVB radiation), and do not contain ingredients known to protect from UVA radiation, the sun rays linked to skin damage and aging, immune system problems, and potentially skin cancer. FDA does not require that sunscreens guard against UVA radiation.
• Sunscreens break down in the sun. Parodoxically, many sunscreen ingredients break down in the sun, in a matter of minutes or hours, and then let UV radiation through to the skin. Our analyses show that 53% of products on the market contain ingredients that may be unstable alone or in combination, raising questions about whether these products last as long as the label says. FDA has not proposed requirements for sunscreen stability.

COMMON MISLEADING CLAIMS

• All day protection
• Waterproof
• Chemical-free
• Read full list
• Questionable product claims are widespread. At least 40% of products on the market bear claims that are considered "unacceptable" or misleading under FDA's draft sunscreen safety standards. Our analysis of marketing claims on hundreds of sunscreen bottles shows that false and misleading marketing claims are common. Claims like "all day protection," "mild as water," and "blocks all harmful rays" are not true, yet are found on bottles. Until FDA sets an effective date for these standards, industry is free to use hyped claims. Companies' decisions to inflate claims has spawned recent class action lawsuits in California.
• Many sunscreens contain nano-scale ingredients that raise potential concerns. Micronized and nano-scale zinc oxide and titanium dioxide in sunscreen provide strong UVA protection, and are contained in many of our top-rated products. Repeated studies have found that these ingredients do not penetrate healthy skin, indicating that consumers' exposures would be minimal. Studies on other nano-scale materials have raised concerns about their unique, toxic properties. FDA has failed to approve effective UVA filters available in Europe that, if approved here, could replace nano-scale ingredients.
• The U.S. lags behind other countries when it comes to products that work and are safe. FDA has approved just 17 sunscreen chemicals for use in the U.S. At least twenty-nine are approved for use in the E.U. FDA has approved only four chemicals effective in the UVA range for use in the U.S., and has failed to approve new, more effective UVA filters available in the E.U. and Asia.
• Some sunscreens absorb into the blood and raise safety concerns. Our review of the technical literature shows that some sunscreen ingredients absorb into the blood, and some are linked to toxic effects. Some release skin-damaging free radicals in sunlight, some act like estrogen and could disrupt hormone systems, several are strongly linked to allergic reactions, and still others may build up in the body or the environment. FDA has not established rigorous safety standards for sunscreen ingredients.

After 29 years of debate, the government has failed to set mandatory sunscreen safety standards. Companies are free to make their own decisions on everything from advertising claims to product quality. In lieu of setting final standards, the Food and Drug Administration (FDA) advises people to stay out of the sun from 10 am to 4 pm. FDA now stands in direct violation a Congressional mandate requiring the agency to finalize sunscreen safety standards by May 2006, flouting not only Congress but also consumers, who are reliant on sunscreen to protect their health.

With no mandatory, comprehensive sunscreen standards in place, products vary widely in safety and effectiveness.

• Recommended: 147 products
• Caution: 409 products
• Avoid: 466 products

	Effective	Moderately Effective	Not Effective
Low Hazard	28 products	13 products	2 products
Moderate Hazard	218 products	282 products	22 products
High Hazard	174 products	269 products	14 products

Source: EWG analysis of ingredients in 1,022 name-brand sunscreens, based on a review of publicly available technical literature. [See methodology.]

Study Methodology

EWG's analysis of sunscreens includes customized safety and effectiveness ratings for 1,022 name-brand products ranging from Coppertone and Banana Boat to Hawaiian Tropic and California Baby. Our ratings are based on a unique, in-house compilation of standard industry, government and academic data sources and models that we have constructed over the past four years, and on an extensive review of the technical literature for sunscreen. We have built product ratings into our popular Skin Deep personal care product safety assessment guide, an online consumer tool that garners about one million searches a month.

For this sunscreen analysis we obtained ingredient listings for 1,022 sunscreens primarily from online retailers. We constructed health hazard ratings for each product based on our analysis of information from our in-house database comprising nearly 60 standard industry, academic, and government regulatory and toxicity databases. We rated products for overall effectiveness in sun protection considering three factors: UVB protection (using SPF rating as the indicator of effectiveness); UVA protection (using a standard industry absorbance model to compute two standard UVA protection factors); and stability (using a customized stability database compiled from a review of industry and peer-reviewed stability studies). Overall, the methods and content of our analysis are based on our review of the technical sunscreen literature, including nearly 400 industry and peer-reviewed studies.

We compiled the results of our analyses in an online interactive sunscreen guide, launched in tandem with this report. Our analyses show that products vary widely, both in their ability to protect from the sun's harmful UV radiation, and in the inherent safety of the ingredients themselves. FDA has set no mandatory standards for any of these factors, and manufacturers are free to make products that may not protect consumers from the sun and that may not be safe when slathered on the skin.

Recommendations

FDA has spent the past 29 years drafting sunscreen standards (FDA 2007), which it urges manufacturers to follow voluntarily. FDA has no public plan for setting a date by which these standards would finally become effective and mandatory. In lieu of enforceable standards, each sunscreen manufacturer decides on test methods, marketing claims, and the level of protection they are willing and able to provide consumers. Health authorities recommend sunscreen, but people are left wondering which of the hundreds of sunscreens on store shelves will best protect their and their families' skin from the sun.

Sunscreens are the tip of the iceberg when it comes to ways that the chemical industry and the government are failing to protect public health. An extensive body of scientific literature demonstrates that everyone in the world carries in their body hundreds if not thousands of industrial chemicals at any given moment, the result of exposures to contaminants in air, water, and food, and to ingredients in everyday consumer products.

No one understands the health implications of our exposures to complex mixtures of low doses of industrial compounds and pollutants: remarkably, federal health standards do not require companies to test their products for safety before they are sold, including nearly all chemicals in sunscreen and other personal care products, and the federal government approves new chemicals for the market using computer models to predict if they are toxic to humans. These are particularly risky methods given the many studies showing that these pollutants cross the placenta to contaminate babies even before the moment of birth, including a recent study conducted by EWG finding an average of 200 chemicals in umbilical cord blood from 10 newborn babies [read more].

This situation is unacceptable. To protect public health, including the health of the fetus, infant, child and others who are most vulnerable to toxic injury, we recommend:

• FDA must set mandatory sunscreen safety standards. As mandated by Congress, FDA must complete their safety standards (the "sunscreen monograph"), and establish a date by which these standards will become mandatory. This study confirms the need for mandatory standards — the voluntary system currently in place leaves the public with many sunscreen products that are not as safe and effective as the public needs and expects.

• FDA must develop UVA standards for sunscreen. While FDA has set guidelines for sunburn (UVB) protection, the agency has not established protocols and requirements for UVA protection. This is a critical gap in public health protection. UVA radiation is deeply penetrating and is linked to skin damage, including premature skin aging, wrinkling, and possibly cancer. FDA is charged with regulating sunscreen and protecting public health, and both of those charges demand that the agency set standards for UVA protection.

• FDA must approve new, effective and safe sunscreens for use in the U.S. Some sunscreen chemicals have been under review at the Agency for over than a decade. Effective sunscreens not approved in this country are in widespread use elsewhere in the world. FDA sorely needs to streamline and modernize its sunscreen review process to give consumers access to the best products possible.

In the larger picture, our system of public health protections allows the vast majority of industrial chemicals to enter commerce with no requirement for premarket safety testing, even for chemicals that will end up in the bodies of Americans from their everyday exposures to ingredients in consumer products. Many state and local organizations and coalitions like the Campaign for Safe Cosmetics are working for important changes that help close the gaps in our system of public health protections.

We not only need sunscreens guaranteed to be safe and effective, but we also sorely need policies that would require companies to document the safety of chemicals before they go on the market. And, most importantly, we need policies that would require that chemicals be safe for the fetus, infant, and other vulnerable populations — a simple, commonsense idea completely absent from current federal law. Such advances would dramatically improve our understanding of health impacts from chemical exposures, and would go a long way toward sealing the gaps that leave consumers at risk from a lifetime of exposure to chemicals.

Study Findings

Because FDA has failed to set UVA standards, many high SPF sunscreens provide only half the protection you need.

People buy high-SPF sunscreens in advance of beach vacations or long days at the pool, assuming they've purchased products that maximize sun protection. High SPF ("Sun Protection Factor") products do protect you from sunburn, the well-known skin cancer precursor caused by the sun's ultraviolet B (UVB) radiation. But these products don't necessarily block UVA radiation, the more deeply penetrating rays linked to skin aging and wrinkling, immune system suppression, and possibly skin cancer.

FDA does not require companies to provide UVA protection in sunscreen, and our analyses show that despite high SPF ratings and "broad spectrum" marketing claims, only a fraction of products provide strong UVA protection. We found poor UVA protection in 12% of high SPF products (30 and higher); in 16% of the 504 products marketed as having "broad spectrum" protection; and in 17% of sunscreens overall.

12% of high SPF products (SPF 30 and higher) have poor UVA protection

product	spf	uva rating
Neutrogena Uva/Uvb Sunblock Lotion, SPF 30	30	9
Neutrogena Sunblock Lotion, SPF 30	30	9
Bronze Sensuale Bambino Carrot Lotion SPF-30, Broad Spectrum	30	9
Bronzo Sensuale Carrot Lotion Broad Spectrum Sun Screen, SPF 30	30	9
Cellex-C Sun Savvy Kit	30+	9

Some sunscreens break down quickly in the sun, becoming ineffective.

It may seem counterintuitive, but of the 17 "active ingredients" that FDA has approved for use as sunscreens in the U.S., at least 4 of them break down significantly when they are exposed to sunlight. They lose their ability to absorb the sun's harmful rays, and stop working effectively in as little as 30 minutes, ranging up to several hours. They require stabilizing chemicals to remain effective.

An ideal sunscreen would be stable in the sun. Instead, nearly every active ingredient (all but zinc oxide and titanium dioxide) works by first absorbing the sun's energy so it doesn't penetrate our skin, and then releasing that captured energy by breaking apart, reacting with other chemicals in the sunscreen, or even kicking off free radicals. Some active ingredients are more stable than others, but nearly all break down to some extent in the sun.

We scoured industry studies and the peer-reviewed literature to compile information on breakdown rates of active ingredients in the sun, combinations of ingredients that accelerate breakdown, and, conversely, chemical additives that can stabilize active ingredients and make them effective longer.

Our analysis of this data against ingredients in 1,022 sunscreens shows that 53% of sunscreens contain ingredients known to break down individually or in combination, with no known stabilizing ingredients in the formulation.

Manufacturers are not required to produce stable products. The test used to establish a product's UVB rating accounts for stability in part, since it tests the product in simulated sunlight on human volunteers over the time needed to produce a sunburn. A product's UVA protection, however, is not subject to testing and rating, and the filters that contribute to UVA protection in a product may or may not be stable.

544 products contain sunscreens that break down in the sun, with insufficient stabilizing chemicals.

product	unstable ingredients	stability rating
NeoStrata Oil-Free Lotion PHA 10 (SPF 15)		10
Nu Skin 180 UV Block Hydrator (SPF 18)		10
NeoStrata Oil-Free Lotion PHA 21 (SPF 15)		10
Dermalogica Multivitamin Hand & Nail Treatment		10
Ombrelle Sunscreen Lotion, SPF 15		10

Over-the-top marketing claims — products would be misbranded if FDA finalized sunscreen standards.

With unenforceable draft guidelines in place of mandatory sunscreen standards, companies are free to use marketing terms that FDA says are confusing, and they are free to sell products that would be considered misbranded if the Agency finalized its guidance. Our analysis shows that fully 40% of sunscreens are labeled with one or more terms that FDA considers indicative of a misbranded product, terms that are just flat out "unacceptable," or terms that could "mislead consumers by inducing a false sense of security."

These include chemical-free, non-chemical, sunblock, reflects, shields from, protects from, filters, screens out, sun's rays, sun's harmful rays, help prevent skin damage, and all SPF designations greater than 30.

We found other products claiming to be sand-proof, to provide "all day" protection, and to be "as mild as water," none of which are possible in the real world. Withough labeling restrictions, consumers are left wondering what is true and what is not. Consumers can be fooled into buying products that don't deliver what they sell.

40% of sunscreens bear claims that the FDA considers unacceptable or indicative of a misbranded product

Claims about...	FDA judgment in draft sunscreen standards...	Offending claims...	Total number of products
what's in the bottle	"likely to be unacceptable" (false and misleading)	chemical-free; non-chemical;	31 products
how sunscreens protect	"could provide the wrong message and a false sense of security to some consumers"	shields from; protects from; filters; screens out; reflects; sunblock;	319 products
the kinds of sunlight sunscreens protect against	"could provide the wrong message and a false sense of security to some consumers"	sun's rays; sun's harsh rays; sun's harmful rays; burning rays;	65 products
what sunscreens protect against	"unsupportable" health claims beyond sunburn	skin aging; wrinkling; premature skin aging; photoaging; lip damage; freckling; uneven coloration; prevent skin damage;	77 products
how well and how long sunscreens protect	"could provide the wrong message and a false sense of security to some consumers"	water proof; extended wear; protects for X number of hours; all day protection; sweat proof; spf >50+;	59 products

U.S. lags behind the world in sunscreen safety and effectiveness.

FDA has approved just 17 sunscreen active ingredients for use in the U.S. In Europe 29 have been approved, including some that are more effective than those available here, particularly for blocking UVA. When FDA issued their so-called final monograph for sunscreens (which they subsequently stayed indefinitely at the request of industry), they received multiple petitions urging that they review active ingredients approved for use in Europe. The Agency replied it would "address sunscreen active ingredients that have foreign marketing experience and data at a future time," a hollow promise if their 30-year track record on developing sunscreen standards is any indication.

FDA faces pressure from industry, states, and Congress to set UVA standards and approve new UVA sunscreens to protect the public. The industry's trade association petitioned the agency to approve new UVA filters beginning in 2003 (CTFA and CHPA 2003). In a May 2007 letter to FDA's commissioner, six senators urged the agency to finish setting UVA standards for sunscreen (Dodd 2007). They reminded the Commissioner that the agency had missed the Congressisonally mandated deadline of May 2006 for finalizing the draft sunscreen standards, including new UVA standards. "We continue to find this baffling [the lack of UVA standards] since many other countries, including the European Union, have adopted sunscreen standards including UVA to protect their citizens," they wrote.

FDA has not reviewed or approved new, effective sunscreens available in other countries.

ingredient	US	EU	AU	Japan
1-(3,4-DIMETHOXYPHENYL)-4,4-DIMETHYL-1,3-PENTA NEDIENE		YES
3-METHYLBENZYLIDENE CAMPHOR			YES
4-(2-BETA-GLUCOPYRANOSILOXY) PROPOXY-2-HYDROXYBENZOPHENONE		YES
4-METHYLBENZYLIDENE CAMPHOR	FDA review pending		YES	YES
BENZOCAINE		YES
BENZOPHENONE-1		YES
BENZOPHENONE-2		YES
BENZOPHENONE-5		YES		YES
BENZOPHENONE-6		YES
BENZOPHENONE-9		YES
BENZYLIDENE CAMPHOR SULFONIC ACID			YES	YES
CAMPHOR BENZALKONIUM METHOSULFATE			YES	YES
DIETHYLAMINO HYDROXYBENZOYLHEXYL BENZOATE			YES
DIETHYLHEXYL BUTAMIDO TRIAZONE	FDA review pending		YES
DIISOPROPYL METHYL CINNAMATE		YES
DISODIUM PHENYL DIBENZIMIDAZOLE TETRASULFONATE			YES
DROMETRIZOLE TRISILOXANE			YES	YES
ETHYLHEXYL DIMETHOXYBENZYLIDENE DIOXOIMIDAZOLIDENE PROPIONATE		YES
ETHYLHEXYL TRIAZONE	FDA review pending	YES	YES	YES
FERULIC ACID		YES
GLYCERYL ETHYLHEXANOATE DIMETHOXYCINNAMATE		YES
GLYCERYL PABA		YES
ISOAMYL P-METHOXYCINNAMATE	FDA review pending		YES	YES
ISOPENTYL TRIMETHOXYCINNAMATE TRISILOXANE		YES
ISOPROPYL METHOXYCINNAMATE		YES
METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL	FDA review pending		YES	YES
PEG-25 PABA			YES	YES
PENTYL DIMETHYL PABA		YES
POLYACRYLAMIDOMETHYL BENZYLIDENE CAMPHOR			YES
POLYSILICONE-15			YES
TINOSORB S	FDA review pending		YES

Some sunscreens absorb into the blood and raise safety concerns.

Most sunscreen chemicals are far from innocuous. In sunlight some release free radicals that can damage DNA and cells, promoting skin aging and possibly raising risks for skin cancer. Some act like estrogen and may disrupt normal hormone signaling in the body, and some may build up in the body and the environment. Details of these risks are presented here.

References

CTFA (Cosmetic, Toiletry, and Fragrance Association) and CHPA (Consumer Healthcare Products Association). 2003. Docket No. 2003N-0233: Notice of eligibility; request for data and information. Letter from Thomas J. Donegan, Jr. of CTFA and Eve E. Bachrach of CHPA to the U.S. Food and Drug Administration. Oct 9 2003. Accessed online July 11, 2007 at http://www.chpa-info.org/Web/newsletter/archive/2003/11_13_03_xnl.html#4

Dodd, Christopher, Jack Reed et al. Dodd, Reed lead fight against skin cancer: Request higher standards for FDA's sunscreen labeling. Letter from Senators Dodd, Reed, Clinton, Biden, Carper, and Sanders to FDA Commissioner Dr. Andrew von Eschenbach. Accessed June 11, 2007 at http://dodd.senate.gov/index.php?q=node/3906.

EPA (U.S. Environmental Protection Agency). 2007. SunWise Program: Health effects of overexposure to the sun. Accessed June 11, 2007 at http://www.epa.gov/sunwise/uvandhealth.html.

FDA (U.S. Food and Drug Administration). 2007. The darker side of tanning. CDRH Consumer Information. Center for Devices and Radiological Health. Accessed June 11, 2007 at http://www.fda.gov/cdrh/consumer/tanning.html.

FDA (U.S. Food and Drug Administration). 2007. Rulemaking History for OTC Sunscreen Drug Products. Accessed June 11, 2007 at http://www.fda.gov/cder/otcmonographs/Sunscreen/new_sunscreen.htm.

NIH (U.S. National Institutes of Health). 2007a. Cancer Topics: What you need to know about melanoma. Accesseed June 11 2007 at http://www.cancer.gov/cancertopics/wyntk/melanoma.

NIH (U.S. National Institutes of Health). 2007. Cancer Topics: Skin Cancer. Accesseed June 11 2007 at http://www.cancer.gov/cancertopics/types/skin.

NIH (U.S. National Institutes of Health). 2007. Cancer Topics: Melanoma. Accesseed June 11 2007 at http://www.cancer.gov/cancertopics/types/melanoma.