Summary of Findings
EWG's 2009 Sunscreen Investigation
Section 1: Summary of Findings
See next section
Summer 2009 sees dramatic shift in sunscreen industry
In a sudden market shift, the number of sunscreens that block harmful UVA radiation more than doubled between summer 2008 and 2009, according to EWG’s analysis of 2,073 brand-name products.*
FDA does not require UVA filters in sunscreens, and most manufacturers have never included them in their formulations. Since the publication of our first sunscreen guide in 2007, EWG has pressured sunscreen manufacturers to provide products that protect the public from UVA radiation.
- In summer 2008 just 29% of sunscreens on the market contained any of the 4 strong UVA filters FDA has approved for use in sunscreens (avobenzone, Mexoryl, titanium dioxide, and zinc), according to EWG’s analysis of product ingredient labels.
- By summer 2009 this number had risen to 70%, a 2.4-fold increase. Many manufacturers reformulated products to include UVA filters, and others introduced new UVA-blocking products to the market. In EWG's database of more than 3,000 sunscreens, brands with at least 35% more products containing strong UVA filters in 2009 compared to 2008 include Solbar, Zia Natural Skincare, Nivea, L'Oreal, Hawaiian Tropic, and No-Ad.
Most sunscreens protect from UVB, or sunburn radiation. Higher SPFs indicate more protection. Far fewer brands contain ingredients that block UVA radiation, even though a growing number of studies show it is even more harmful than UVB radiation. UVA radiation hastens the progression of skin cancer, suppresses the immune system, and ages the skin over time.
Despite the increased use of UVA filters, 1 in 9 products confers dangerously low levels of UVA protection. In August 2007 FDA proposed a 4-star rating system for UVA protection and a requirement that the rating appear on sunscreen labels. FDA has not finalized this proposal. No brands are posting the new UVA rating voluntarily, according to EWG’s review of 1,694 sunscreens available in summer 2009, so consumers are left guessing which among the many products on store shelves will give them the UVA protection they need.
- 61 sunscreens with SPFs from 55-100+ might tempt you to stay out longer in the sun, but they block just 1-2% more sunburn (UVB) radiation than an SPF 30 sunscreen and aren't required to block UVA. Compared to an SPF 30 sunscreen, they also require 2-3 times more active ingredients, many of which absorb into the body.
- Hundreds of all-day moisturizers advertise SPF protection, but 1 in 5 offers little protection from harmful UVA rays. Some break down well before the day's end. A surprising new government report attributes an increasing incidence of malignant melanoma among people who work indoors to UVA rays shining through windows onto unprotected skin (Godar 2009).
- Lip cancer is most common on the bottom lip where sun exposure is most direct. Two of 5 lip balms with SPF offer poor UVA protection.
Less dramatic but still significant, a 19% drop in the use of oxybenzone, a hormone disruptor approved as an active ingredient in sunscreens, signals the industry's shift to safer ingredients. U.S. Centers for Disease Control and Prevention (CDC) has found detectable levels of oxybenzone in the urine of 97% of Americans over the age of six. In laboratory tests, oxybenzone been shown to disrupt the endocrine system and release reactive oxygen species that could contribute to skin cancer. Up to 9% of oxybenzone applied to the skin absorbs into living tissues and blood vessels below the surface.
- In summer 2008 52% of sunscreens on the market contained oxybenzone, according to EWG’s analysis of product ingredient labels.
- By summer 2009 this number had dropped to 42%. In EWG's database of 2,073 sunscreens*, brands with at least 25% fewer products containing oxybenzone in 2009 compared to 2008 include Solbar, B Kamins, MD Skincare, Vincent Longo, No-Ad, and KINeSYS.
EWG recommends that consumers avoid sunscreens with oxybenzone. Industry's shift away from the chemical may signal their recognition of the risks inherent in a hormone-disrupting chemical that readily absorbs through human skin.
FDA Fails to Protect Consumers from Ineffective and Unsafe Sunscreens
On August 27, 2007 the U.S. Food and Drug Administration (FDA) published proposed amendments to the final monograph for sunscreen drug products for over-the-counter human use. FDA has published this document in various versions beginning with the first version 31 years ago (FDA 1978). FDA’s delay in finalizing the monograph and enforcing its provisions has spurred a number of actions, including:
- 9 class-action, false-advertising lawsuits (Joseph Goldstein v. Schering-Plough Corporation, et al., 2006);
- A state Attorneys General petition requesting the Agency to set standards (Blumenthal 2006);
- A Congressional mandate for FDA to finalize the document (HR 2744, 2005); and
- At least two subsequent written requests from seven Senators urging the Agency to finalize the monograph in order to protect the public from skin cancer (Dodd 2007, Kerry 2007).
EWG’s research reveals serious deficiencies in the safety and efficacy of sunscreen sold in the U.S., deficiencies that persist because of FDA’s delay in finalizing the standards contained in the monograph (EWG 2007a).
Summary of 2009 Sunscreen Analysis
In an analysis of 1,694 name-brand sunscreens* on the market in summer 2009, the Environmental Working Group (EWG) found that 3 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 45 sunscreen products met EWG's criteria for safety and effectiveness, and only 2 of 158 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 1 of every 9 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 100 products that offer very good sun protection with ingredients that present minimal health risks to users.
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 6% of 1,694 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 5% 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 40% 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.
- 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: 113 products
- Caution: 1,296 products
- Avoid: 320 products
| Effective | Moderately Effective | Not Effective | |
| Low Hazard | 46 products | 36 products | 4 products |
| Moderate Hazard | 153 products | 552 products | 28 products |
| High Hazard | 197 products | 672 products | 41 products |
Source: EWG analysis of ingredients in 1,694 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 1,694 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.
- 1,694 sunscreens
- Sun hazard (effectiveness) ratings for UVA protection, UVB protection, and stability in sun
- Health hazard (safety) ratings for all ingredients
- 14 of 17 active ingredients approved in the U.S. (the ones found in products)
- 2 active ingredients approved in other countries (listed as "inactive" ingredients in U.S. sunscreen)
- 2,181 other ingredients (not sunscreen)
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 5% of high SPF products (30 and higher); in 8% of the 666 products marketed as having "broad spectrum" protection; and in 11% of sunscreens overall.
5% of high SPF products (SPF 30 and higher) have poor UVA protection
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 1,694 sunscreens shows that 40% 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.
685 products contain sunscreens that break down in the sun, with insufficient stabilizing chemicals.
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 43% 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.
43% 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; | 94 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; | 431 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; | 109 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; | 135 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+; | 318 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.
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 are 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.
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.
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.
FDA (U.S. Food and Drug Administration). 1999. Sunscreen Drug Products For Over-The-Counter Human Use; Final Monograph. Final rule. Federal Register: May 21, 1999 (Volume 64, Number 98), Page 27666-27693. (Stayed on December 31, 2007.)
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.
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
*Note: EWG's database of sunscreens on the market in 2009 contains 1,694 products. Most analyses presented in this investigation draw from this database. Analyses that compare 2008 and 2009 sunscreens are drawn from a database of 2073 products. To construct this database we pooled our 2008 and 2009 sunscreen databases, and then removed the subset of products manufactured by companies who have signed the Compact for Safe Cosmetics, so that the final database could represent a more accurate picture of the marketplace. (Compact signer's products are overrepresented in our database. Most of the sunscreens marketed by these companies are zinc or titanium; their inclusion in our 2008-2009 comparative calculations would skew the results.)
