25 Feb 2019
Proposal to Update Requirements for Most Sunscreen Products under Consideration
The Food and Drug Administration is seeking input by 27 May on a proposal that would update regulatory requirements for most sunscreen products in the United States. According to an FDA press release, the proposal is aimed at bringing non-prescription, over-the-counter sunscreens that are marketed without FDA-approved applications up to date with the latest science to better ensure consumers have access to safe and effective preventative sun care options. Among other things, the proposal addresses sunscreen active ingredient safety, dosage forms and sun protection factors, as well as broad-spectrum requirements. It also proposes updates to how products are labelled to make it easier for consumers to identify key product information.
According to FDA Commissioner Scott Gottlieb, given that some of the essential requirements of broad spectrum sunscreens with SPF values of at least 15 have not been updated in decades, the proposal represents “an important step in the FDA’s ongoing efforts to take into account modern science to ensure the safety and effectiveness of sunscreens” as it would “improve quality, safety and efficacy of the sunscreens Americans use every day.”