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Better products coming but most still offer inferior protection or use concerning ingredients
Another summer is here, and shelves remain packed with sunscreen products that provide inferior sun protection and are made with ingredients that could negatively affect our health.
In the 1970s, pioneering research by Margaret Kripke and her colleagues showed that UV radiation can do systemic harm to the immune system. Subsequent studies by other researchers found that the immune protection of sunscreens was not correlated to their SPF, or sun protection factor, or the protection from UVB rays, but to the UVA protection.
Over the past decade, the FDA has made multiple proposals to strengthen UVA protection in sunscreen products, but none has been made law. Last year, the FDA again proposed changes to require greater UVA protection, but they were postponed.
For the time being, inferior products will remain on store shelves, despite scientific evidence that the most common ingredients are absorbed into the blood at levels that can cause harm, lack adequate safety testing and are formulated into products that may not adequately protect users from dangerous UVA rays.
Now more than ever, it’s a good idea for consumers to turn to EWG’s 14th Annual Sunscreen Guide to find safer, more effective products. This year we assessed more than 1,300 products with SPF, including more than 700 currently available beach and sport sunscreens, and found that only about a quarter of products offer adequate protection and do not contain concerning ingredients, such as oxybenzone, a potentially hormone-disrupting chemical that is readily absorbed by the body.
Last spring, the FDA published proposed sunscreen rules which indicated that most ingredients were inadequately tested for safety and implied that these ingredients would be removed from the market unless appropriate safety testing was conducted. The proposed rules were to be finalized by the end of 2019 but must now be re-proposed by the FDA. Given the delay, it remains unclear when consumers will see better sun protection products.
While the industry stalls, the FDA has been busy completing tests and proposing changes. The agency published two scientific studies last year showing that, with just a single application, all non-mineral sunscreen ingredients are readily absorbed through the skin and could be detected in our bodies at levels that could cause harm.
EWG continues to hone our recommendations by strengthening our criteria for assessing sunscreens, based on the latest findings in the scientific literature and commissioned tests of sunscreen product efficacy. This year we made additional modifications to our methodology to strengthen the requirements products must meet to make our list of top recommendations.
UVA protection is critical, and our changes strengthen the amount of UVA protection a sunscreen must provide. For products that fell short of our new standard, we invite companies to provide additional documentation in the form of verified laboratory test reports showing that the product meets not only the FDA’s UVA standards but also European UVA standards and to EWG’s even more stringent standard, to ensure the highest levels of UVA protection.
New sunscreen tests from the FDA show that with just a single application at the beach or pool, six commonly used chemical active ingredients were absorbed into the body and continued to be absorbed through the skin for days or longer. What is most alarming about these findings is that chemicals are being absorbed in significant amounts and have not been adequately tested for safety.
Nearly three weeks after applying sunscreen, it was still possible to detect the chemicals that had not yet been absorbed into participants’ skin. Levels on the skin went down significantly in the days between the first and third weeks, but most likely because the sunscreen was absorbed into the blood.
The FDA first began working to update sunscreen regulations more than 40 years ago. In February 2019, the agency at long last issued a proposed set of final rules, but they were never adopted. As written, the new rules would bring significant advances in both effectiveness and safety. Now the law requiring the FDA to finalize sunscreen rules has been rewritten, and new regulations will likely not come for at least two more years.
The FDA is likely to propose the same changes again. Here is what the agency proposed in 2019 that would make sunscreens better.
For decades, Americans have been told that sunscreen use is critical to prevent lasting skin damage and skin cancer from sun exposure. But the FDA has not ensured that the ingredients meant to provide such protection have been adequately tested for safety and efficacy.
Based on existing test data, the agency’s proposal recognized as safe and effective just two ingredients, zinc oxide and titanium dioxide. From the beginning, EWG has recommended that consumers choose sunscreen products made with zinc oxide and titanium dioxide, which meet our standards for effectiveness and safety.
The FDA proposed that 12 other active ingredients commonly found in sunscreens, including oxybenzone, need additional data from safety and efficacy tests. Those ingredients are used in about 50 percent of the sunscreens we assessed for this year’s guide. The FDA requested the same data that the agency requires for ingredients used elsewhere in the world that companies want to use in U.S. sunscreens..
The FDA’s proposal also recognized two active ingredients, PABA and trolamine salicylate, as unsafe, as suggested by the available scientific literature. These ingredients are rarely, if ever, used in sunscreen anymore.
Particular concern about oxybenzone – especially for kids
Oxybenzone is one of the most commonly used sunscreen active ingredients, found in more than 40 percent of the non-mineral sunscreens in this year’s guide. In 2008, EWG called on the FDA to investigate the safety of oxybenzone in sunscreen, because of mounting evidence that the chemical readily penetrates the skin and could potentially disrupt the hormone system.
The FDA’s proposal confirms our position, saying that although oxybenzone is one of the more thoroughly tested sunscreen ingredients, additional data is needed because existing tests raise health concerns. Of particular concern to the FDA were test results showing:
The agency is requesting studies of oxybenzone that measure skin absorption and potential impacts on the hormone levels, reproduction and development.
According to the FDA, higher SPF values have not been shown to provide additional clinical benefit and may provide users with a false sense of security. To guard against this misconception, the agency proposes limiting products’ SPF claims to 60+.
The FDA is concerned that claims of excessively high SPF values give users a false sense of protection, leading to overexposure to UVA rays that increase the risk of long-term skin damage and cancer. The FDA emphasized that the SPF cap, along with proposed changes to the broad spectrum test, are needed to ensure that sunscreens provide more UVA protection.
This is not the first time the FDA has raised concerns about high SPF products. In 2011, an earlier draft of the proposed rules recommended a SPF cap of 50+. We see the latest proposal, recommending a cap of 60+, as a step backward. To justify this change, the FDA cites only studies of sunscreens with active ingredients that are not allowed for use in the U.S. Therefore, it remains unclear whether this change will be feasible or beneficial to the U.S. market.
More than 10 percent of the sunscreens in this year’s guide claim an SPF of greater than 50+. EWG recommends that consumers avoid products that claim an SPF higher than 50+.
The FDA proposal recommends changes to the method companies must use to evaluate sunscreens’ broad-spectrum UVA protection. The agency proposes a test it initially put forward in 2007, to ensure greater UVA protection. At the time, sunscreen manufacturers fought this change and the agency relented, enabling substandard and potentially harmful products to remain on the market for a decade more.
EWG is supporting this proposed change as an important improvement but advocates that the final standard be even more protective. Our modeling predicts that many high-SPF products would pass the proposed FDA test but offer inadequate UVA protection nonetheless.
In 2011, when the FDA proposed its current UVA standard, we estimated that 80 percent of products would pass without any changes to their formulations. The European Union sets a higher bar, requiring UVA protection to rise in proportion with SPF, and the latest FDA proposal would bring U.S.-sold sunscreens closer to that standard. This year we strengthened our UVA standard even further to go beyond what is required in Europe.
Sunscreen sprays pose an inhalation risk and may not provide an adequate coating on the skin to ensure proper protection. The number of sunscreen sprays on the U.S. market has been increasing, and more than a quarter of the sunscreens in this year’s guide are in spray form.
The FDA proposed that all spray and powdered sunscreens be tested to ensure they cannot be inhaled deep into the lungs, where they could do irreversible damage. In pilot testing, the agency found that three of 14 sprays would not meet its proposed standard but did not say which products consumers should avoid. EWG recommends that consumers avoid all spray and powder sunscreen products.
The agency has also proposed numerous other changes to the sunscreen regulations that should better protect consumers, including:
The changes proposed by the FDA focus on effectiveness and the safety of active ingredients. They do not address concerns EWG has raised about the use of other worrisome ingredients, such as retinyl palmitate, a form of vitamin A that may harm sun-exposed skin.
Whenever new rules are passed – if they are – consumers should make sun safety a daily habit by covering up with clothing, seeking shade, planning around the sun and using sunscreen when needed. Enjoy the summer and don’t get burned.
 Besides oxybenzone, they are avobenzone, homosalate, octinoxate, octisalate, octocrylene, cinoxate, dioxybenzone, ensulizole, meradimate, padimate O and sulisobenzone.
 A cap of 60+ means that although companies may consider their product’s formulation to have a higher SPF value than 60, they can’t label it with a higher number.
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Take EWG's Sunscreen Guide with you! Download the Healthy Living App Today