In a statement from US Food and Drug Administration Commissioner Scott Gottlieb, MD, the agency warns against companies marketing substandard sunscreen products, including pills, capsules, and dietary supplements with false claims of sun protection.

Warning letters were sent to GliSODin Skin Nutrients (Advanced Skin Brightening Formula), Napa Valley Bioscience (Sunsafe Rx), Pharmacy Direct, Inc. (Solaricare), and Sunergized LLC (Sunergetic). The FDA notes that these products are misleading consumers and creating a health risk by “giving consumers a false sense of security that a dietary supplement could prevent sunburn, reduce early skin aging caused by the sun, or protect from the risks of skin cancer,” according to the statement.

“There is no pill or capsule that can replace your sunscreen,” Dr Gottlieb emphasized.

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Dr Gottlieb also noted that the FDA is encouraging the sunscreen industry to conduct research on active ingredients in sunscreen products to help answer critical safety questions. Sunscreen use has increased overall, resulting in more contact with active ingredients. Advances in scientific understanding have “given rise to new questions about what information is necessary and available to support general recognition of safety and effectiveness for use in [over-the-counter] sunscreens.”

The 2014 Sunscreen Innovation Act created a new process for the FDA to review the safety and effectiveness of active ingredients in sunscreen. The FDA is continuing those efforts with new industry draft guidance for Maximal Usage Trials, Congressional reporting, and advancing scientific standards. The agency will also continue to examine sunscreen dosages and the effectiveness of SPF values.

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“Advancing [ultraviolet] protection has been a key goal of efforts by the healthcare community and government agencies,” said Dr Gottlieb. “We need to continue to take steps to build on these goals and efforts. That starts with making sure that products marketed to offer protection from the sun’s effects actually deliver these promises.”


Statement from FDA Commissioner Scott Gottlieb, MD, on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens [news release]. Silver Springs, MD: US Food and Drug Administration. Published May 22, 2018. Accessed May 29, 2018.