December 11, 2025

Based on FDA’s review, bemotrizinol provides broad-spectrum protection against both UVA and UVB rays, shows low systemic absorption, and rarely causes skin irritation. If finalized, the ingredient would be considered generally recognized as safe and effective (GRASE) for use in sunscreens for adults and children aged 6 months and older, at concentrations up to 6 percent.

The proposal follows an OTC Monograph Order Request (OMOR) submitted by DSM Nutritional Products LLC. Although bemotrizinol has been used in sunscreens internationally for years, it has not previously been approved in the U.S. or included in the FDA’s sunscreen monograph.

FDA Commissioner Marty Makary, M.D., M.P.H., emphasized that the agency is working to modernize sunscreen regulation, noting that Americans have historically had fewer sunscreen options than consumers abroad. FDA officials also highlighted that reforms under the CARES Act have streamlined the OTC monograph process, enabling faster review of new ingredients.

The FDA is now seeking public comment on the proposed order. If the agency ultimately determines that bemotrizinol meets GRASE standards, it will issue a final order adding the ingredient to OTC Monograph M020 for sunscreens.

The FDA continues to encourage sunscreen use, along with other sun-protective measures, to help prevent sunburn, skin cancer, and premature skin aging.