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Better products coming but most still offer inferior protection or use concerning ingredients
Since 2007, EWG’s annual Guide to Sunscreens has exposed how many sunscreen products sold in the U.S. fall short of effectively and safely protecting people, and has advised consumers on safer and more effective choices. At the same time, we’ve pushed the Food and Drug Administration to update and improve sunscreen regulations, urging the agency to set stricter standards to better protect public health.
The good news: The FDA is finally proposing big changes that address many of our concerns, and should make all sunscreens safer and more effective.
But wait: Those changes will not be in sunscreens on the shelves this year. For this year’s Guide, we assessed more than 1,300 products with SPF, including 750 currently available beach and sport sunscreens, and found that about two-thirds still offer inferior sun protection or contain concerning ingredients, such as oxybenzone, a potentially hormone-disrupting chemical that is readily absorbed by the body.
The FDA first began the process of updating sunscreen regulations more than 40 years ago. In February, the agency at long last issued a proposed set of final rules. As written, the new rules would bring significant advances in both effectiveness and safety. But many big chemical manufacturers and sunscreen companies are lobbying heavily for a much weaker proposal that would likely leave the state of sunscreens in the U.S. largely unchanged.
Here are some of the most important changes proposed by the FDA, and how they relate to our advice in this year’s and previous years’ Guides.
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.
Now the FDA is for the first time proposing that active ingredients in sunscreen be sufficiently tested to determine the rate of absorption through the skin and the health impacts that may result from exposure to those ingredients. Based on existing test data, the agency’s proposal recognizes as safe and effective just two ingredients, zinc oxide and titanium dioxide. From the beginning, EWG’s Guide has recommended that consumers choose sunscreen products made with zinc oxide and titanium dioxide, which meet our standards for effectiveness and safety.
The FDA proposes that 12 other active ingredients commonly found in sunscreens, including oxybenzone, need additional data from safety and efficacy testing. Those ingredients are used in more than 50 percent of the sunscreens EWG assessed for this year’s Guide.
The test data the FDA is requesting on these existing ingredients are the same as those required by the agency for ingredients used elsewhere in the world that companies want to introduce in U.S. sunscreens. But the FDA will likely give companies additional time to conduct the tests and submit the data, and until then, those ingredients can remain in sunscreens sold in the U.S.
The FDA’s proposal also recognizes two active ingredients, PABA and trolamine salicylate, as unsafe based on 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 60 percent of the non-mineral sunscreens in this year’s Guide. In 2008, EWG called on the FDA to investigate the safety of oxybenzone use in sunscreen, because of mounting evidence that the chemical readily penetrates the skin and could potentially disrupt the human 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 sun protection factor values, or SPF, 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 backwards. 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 that UVA protection increase with UVB 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 will advocate that the final standard be even more protective. Our modeling predicts that many high SPF products would pass the proposed FDA test but still offer inadequate UVA protection.
When the FDA proposed its current UVA standard, in 2011, 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 sunscreen closer to that standard.
EWG is concerned that 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 proposes that all spray and powdered sunscreens be tested to ensure they cannot be inhaled deep into the lungs, where they could do irrevocable 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 are focused 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.
The FDA is expected to finalize the sunscreens rule before the end of the year. Regardless of the new rules, 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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