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The FDA's New Rules for Sunscreens

Jun 3, 2013

This year’s quickly approaching summer season will see changes in how sunscreens are labeled, as most sunscreen on store shelves will have to conform to new U.S. Food and Drug Administration (FDA) labeling rules.

Under the new regulations, sunscreen products that protect against all types of sun-induced skin damage will be labeled "Broad Spectrum" and “SPF 15” (or higher) on the front. Those products that pass the broad spectrum test will provide protection against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA).

Sunburn is primarily caused by UVB; however, both UVB and UVA can cause sunburn, skin cancer, and premature skin aging. A certain percentage of a broad spectrum product’s total protection is against UVA; however, sunscreen not labeled as “Broad Spectrum” or with an SPF value of between 2 and 14 has only been shown to help prevent sunburn.

“Sunscreen is not a magic bullet,” Dr. Steven Q. Wang, director of dermatologic surgery and dermatology at Memorial Sloan-Kettering Cancer Center in Basking Ridge, New Jersey, told The New York Times. Dr. Wang is also a spokesman for the Skin Cancer Foundation, which receives funding from sunscreen manufacturers. “It’s just one of the defenses against the harmful effect of UV radiation, and that message gets lost,” he added.

To reduce the risks of skin cancer and early skin aging, the FDA urges consumers to spend less time in the sun, especially during the hours of 10:00 a.m. and 2:00 p.m., when the sun’s rays are the strongest, and to use sunscreens with broad spectrum SPF values of 15 or higher, according to the Times. Be sure to wear clothing and accessories that cover the skin; reapply sunscreen at least once every two hours if sweating or in and out of the water.

Sonya Lunder, a senior analyst for the Environmental Working Group (EWG) and an author of its sunscreen report, has criticized the agency, pointing out that Europe and Canada have stronger sunscreen standards. “In the U.S., you can make a bad sunscreen and just not call it ‘broad spectrum,’ but still sell it,” Lunder told the Times. “In Europe, the pass-fail test is stronger, and it must protect against both UVA and UVB.”

Lunder and the Times say that consumers should look for products that contain an SPF of 15 to 50 that are labeled “broad spectrum protection,” and they should keep babies under 6 months of age out of the sun—and not use sunscreen on infants. Also, children should be kept out of the sun during its peak hours, as a bad sunburn in younger years doubles the risks for melanoma later in life.

Avoid sunscreen sprays—powders are banned, although some might still be on shelves—as more data is needed on these products, which may contain insufficient sunscreen and which may be inhaled, the Times noted. Avoid products with vitamin A, retinol, or retinol derivatives (retinyl palmitate, retinyl acetate) as insufficient evidence on their safety exists. Canadian health authorities have expressed concern that these additives increase sun sensitivity. The EWG also recommends avoiding products containing oxybenzone due to its hormone-disrupting properties; use products with zinc oxide and titanium dioxide as active ingredients. And, try to use fragrance-free products when possible.

Be careful of hype and advertising. The Skin Cancer Foundation provides a “seal of recommendation” to sunscreens if their manufacturer has donated $10,000 to become a member of the organization, according to the Times.

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