The Sunscreen Innovation Act was enacted on November 26, 2014, to help expedite the approval process for UV filters by the US Food and Drug Administration (FDA), given that no new filters had been approved in several years. Nearly 5 years later, on February 26, 2019, the FDA released a proposed rule (84 FR 6204)1,2 in response to the Sunscreen Innovation Act that addressed the classification and labeling of over-the-counter sunscreen products. A component of this FDA proposal is to classify the 16 sunscreen active ingredients (ie, UV filters) listed in the 1999 FDA final monograph into 3 categories: category I, generally recognized as safe and effective (GRASE); category II, not GRASE; and category III, insufficient safety data to support a positive GRASE determination. Currently, sunscreen manufacturers are working with the FDA to discuss safety data needed for 8 of the 12 active ingredients listed in category III.
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Mohammad TF, Lim HW. The Important Role of Dermatologists in Public Education on Sunscreens. JAMA Dermatol. Published online March 24, 2021. doi:10.1001/jamadermatol.2020.5393
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