Sunscreen Summary — What Works and What's Safe

Authors: Sean Gray, Senior Analyst; Sonya Lunder, MPH, Senior Analyst; Kristan Markey, Analyst (former); Rebecca Sutton, Ph.D., Staff Scientist; Nneka Leiba, MPH, Researcher; Jane Houlihan, Vice President for Research

In a new investigation of 952 name-brand sunscreens, the Environmental Working Group (EWG) found that 4 out of 5 sunscreen products offer inadequate protection from the sun, or contain ingredients with significant safety concerns. Leading brands were the worst offenders: None of market leader Coppertone's 41 sunscreen products met EWG's criteria for safety and effectiveness, and only 1 of 103 products from Banana Boat and Neutrogena, the second- and third-largest manufacturers, are recommended by EWG.

Many products on the market present obvious safety and effectiveness concerns, including one of every seven that does not protect from UVA radiation This problem is aggravated by the fact that FDA has not finalized comprehensive sunscreen safety standards they began drafting 30 years ago. Overall we identified 143 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.

• Only 15% of 952 products analyzed met EWG's criteria for safety and effectiveness, 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 detailed review of hundreds of 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. Our analysis found that 7 percent of high SPF sunscreens (SPF of at least 30) protect only from sunburn (UVB radiation), and do not contain ingredient combinations known to protect from UVA, 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. Paradoxically, 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 48% 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
• Broad-spectrum protection
• All day protection
• Waterproof
• Chemical-free
• Read full list
• Questionable product claims are widespread. Many products on the market bear claims that are considered "unacceptable" or misleading under FDA's draft sunscreen safety standards. 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 spurred 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. Powder and spray sunscreens with nano-scale ingredients raise greater concerns, since particles might absorb more easily through the lungs than the skin. Studies of 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 29 are approved for use in the E.U. FDA has approved only 4 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 could disrupt hormone systems, several are strongly linked to allergic reactions, and others may build up in the body or the environment. FDA has not established rigorous safety standards for sunscreen ingredients that fully examines these effects.

After 30 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. FDA now stands in direct violation of 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: 143 products
• Caution: 314 products
• Avoid: 495 products

	Effective	Moderately Effective	Not Effective
Low Hazard	28 products	10 products	2 products
Moderate Hazard	212 products	198 products	9 products
High Hazard	233 products	240 products	20 products

Source: EWG analysis of ingredients in 952 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 952 name-brand products including Coppertone, Banana Boat, 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 5 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 1 million searches a month.

For this sunscreen analysis we obtained ingredient listings for 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 3 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 database compiled from a review of industry and peer-reviewed studies of how quickly different sunscreen ingredients break down in the sun). 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 30 years drafting sunscreen standards (FDA 2007a), which it urges manufacturers to follow voluntarily. FDA issued its latest draft standards in August 2007, which include a proposal for first-ever UVA standards, but still has failed to finalize the standards to make them 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 industrial compounds and pollutants: remarkably, federal health standards do not require companies to test most products for safety before they are sold, including nearly all chemicals in sunscreen and other personal care products. Little is known about the safety of most industrial chemicals. In the absence of data the federal government approves new chemicals for the market using computer models to predict if they are toxic to humans. This is concerning given that these pollutants cross the placenta, subjecting the developing fetus to hundreds of chemicals. A recent study conducted by EWG found an average of 200 chemicals in umbilical cord blood from 10 newborn babies [read more]. Two recent studies highlight widespread exposure to the common sunscreen chemical oxybenzone, and associate concentrations of this chemical in pregnant women to lower birthweight in their daughters (Calafat 2008, Wolff 2008).

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 finalize 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 or expects.
• FDA must approve new, effective and safe sunscreens for use in the U.S. Some sunscreen chemicals have been under review at FDA 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.

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 UVB rays. But these products don't necessarily block UVA rays, the more deeply penetrating radiation 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 7% of high SPF products (30 and higher); in 11% of the 507 products marketed as having "broad spectrum" protection; and in 14% of sunscreens overall.

7% of high SPF products (SPF 30 and higher) have poor UVA protection

product	spf	uva rating
Banana Boat Kids Tear Free Sunblock Lotion, SPF 30	30	9
Joesoef Moisturizing Lotion, for All Skin Types, SPF 30	30	8
Coppertone KIDS Lotion Spray Sunscreen, SPF 45	45	8
Coppertone KIDS Lotion Spray Sunscreen, SPF 30	30	8
No-Ad Sunscreen Continuous Spray, SPF 30	30	8

See more >>

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 952 sunscreens shows that 48% 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.

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

product	unstable ingredients	stability rating
Neutrogena Summer Glow Dialy Moisturizer, SPF 15	AVOBENZONE (PARSOL 1789 | BUTYL METHOXYDIBENZOYLMETHANE); HOMOSALATE; OCTINOXATE (OCTYL METHOXYCINNAMATE)	8
Lumene Premium Beauty Rejuvenating Hand Treatment, SPF 15	AVOBENZONE (PARSOL 1789 | BUTYL METHOXYDIBENZOYLMETHANE); OCTINOXATE (OCTYL METHOXYCINNAMATE); OXYBENZONE (BENZOPHENONE-3)	8
Lumene Sun Defence Protective Sun Care, SPF 15	AVOBENZONE (PARSOL 1789 | BUTYL METHOXYDIBENZOYLMETHANE); OCTINOXATE (OCTYL METHOXYCINNAMATE); OXYBENZONE (BENZOPHENONE-3)	8
Lumene Vita-Nectar Vitalizing Day Cream, SPF 15	AVOBENZONE (PARSOL 1789 | BUTYL METHOXYDIBENZOYLMETHANE); OCTINOXATE (OCTYL METHOXYCINNAMATE)	8
Roc Retinol Correxion Deep Wrinkle Daily Moisturizer, SPF 15	AVOBENZONE (PARSOL 1789 | BUTYL METHOXYDIBENZOYLMETHANE); OCTINOXATE (OCTYL METHOXYCINNAMATE)	8

See more >>

Over-the-top marketing claims — many 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 has said are confusing, and they are free to sell products that would be considered misbranded if the Agency finalized its guidance (FDA 2007, FDA 1999). Our analysis of products showed that fully 53% of sunscreens were labeled with one or more terms that FDA has said are indicative of a misbranded product, terms that are "unacceptable," or terms that could "mislead consumers by inducing a false sense of security".

These include "chemical-free," "non-chemical," "help prevent skin damage," as well as terms like "sunblock," "reflects," "shields," "protects," "filters," "screens," "sun's rays," "sun's harmful rays," and all SPF designations greater than 50.

In addition to claims specifically targeted by FDA, we found many more that would also mislead consumers, including claims of "sand-proof," "all day" protection, "instant protection" or "as mild as water," none of which is possibly true. Without labeling restrictions, consumers are left wondering what is true. Consumers can be fooled into buying products that don't deliver what they sell.

53% 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;	43 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;	293 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;	87 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;	75 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+;	247 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, 6 senators urged the agency to finish setting UVA standards for sunscreen (Dodd 2007). They reminded the Commissioner that the agency had missed the Congressionally 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	status in the US	status in the EU, Australia, and Japan
1-(3,4-DIMETHOXYPHENYL)-4,4-DIMETHYL-1,3-PENTA NEDIENE		Approved in the EU
3-METHYLBENZYLIDENE CAMPHOR		Approved in Australia
4-(2-BETA-GLUCOPYRANOSILOXY) PROPOXY-2-HYDROXYBENZOPHENONE		Approved in the EU
4-METHYLBENZYLIDENE CAMPHOR	FDA review pending	Approved in Australia & Japan
BENZOCAINE		Approved in the EU
BENZOPHENONE-1		Approved in the EU
BENZOPHENONE-2		Approved in the EU
BENZOPHENONE-5		Approved in the EU & Japan
BENZOPHENONE-6		Approved in the EU
BENZOPHENONE-9		Approved in the EU
BENZYLIDENE CAMPHOR SULFONIC ACID		Approved in Australia & Japan
CAMPHOR BENZALKONIUM METHOSULFATE		Approved in Australia & Japan
DIETHYLAMINO HYDROXYBENZOYLHEXYL BENZOATE		Approved in Australia
DIETHYLHEXYL BUTAMIDO TRIAZONE	FDA review pending	Approved in Australia
DIISOPROPYL METHYL CINNAMATE		Approved in the EU
DISODIUM PHENYL DIBENZIMIDAZOLE TETRASULFONATE		Approved in Australia
DROMETRIZOLE TRISILOXANE		Approved in Australia & Japan
ETHYLHEXYL DIMETHOXYBENZYLIDENE DIOXOIMIDAZOLIDENE PROPIONATE		Approved in the EU
ETHYLHEXYL TRIAZONE	FDA review pending	Approved in the EU & Australia & Japan
FERULIC ACID		Approved in the EU
GLYCERYL ETHYLHEXANOATE DIMETHOXYCINNAMATE		Approved in the EU
GLYCERYL PABA		Approved in the EU
ISOAMYL P-METHOXYCINNAMATE	FDA review pending	Approved in Australia & Japan
ISOPENTYL TRIMETHOXYCINNAMATE TRISILOXANE		Approved in the EU
ISOPROPYL METHOXYCINNAMATE		Approved in the EU
METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL	FDA review pending	Approved in Australia & Japan
PEG-25 PABA		Approved in Australia & Japan
PENTYL DIMETHYL PABA		Approved in the EU
POLYACRYLAMIDOMETHYL BENZYLIDENE CAMPHOR		Approved in Australia
POLYSILICONE-15		Approved in Australia
TINOSORB S	FDA review pending	Approved in Australia

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, promote skin aging, and possibly raise risks for skin cancer. Some act like estrogen and may disrupt normal hormone signaling in the body. Others some may build up in the body and the environment. Details of the health concerns for active ingredients is presented here.

References

Calafat AM, Wong L-Y, Ye X, Reidy JA, Needham LL. 2008. Concentration of the sunscreen agent, benzophenone-3, in residents of the United States: National Health and Nutrition Examination Survey 2003-2004. Environmental Health Perspectives 116:7(893-7).

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.

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.

FDA (U.S. Food and Drug Administration). 2007. Sunscreen Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph; Proposed Rule. Federal Register: August 27, 2007 (Volume 72, Number 165). Page 49069-49122.

Wolff MS, Engel SM, Berkowitz GS, Ye X, Silva MJ, Zhu C, et al. 2008. Prenatal phenol and phthalate exposures and birth outcomes. Environmental Health Perspectives: DOI:10.1289/ehp.11007