FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Proposes Tougher Testing of OTC Sunscreens

Feb. 28, 2019
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The FDA issued a proposed rule that would introduce tougher requirements for OTC sunscreen drug products.

The rule proposes to require that all sunscreen products with SPF values of 15 and above meet broad spectrum UV requirements. The agency says the rule will clear up confusion under the current labeling regime in which higher-numbered SPF products sometimes provide less protection than lower-numbered products.

The rule also proposes to require that all products with SPF values of at least 15 be labeled with a number that corresponds to the lowest number in a range of tested results. For example, products testing from SPF 15 to 19 would be labeled SPF 15.

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