FDA

FDA proposes adding bemotrizinol as a permitted sunscreen ingredient

December 16, 2025

FDA has proposed adding bemotrizinol as a permitted active ingredient in over-the-counter sunscreens, citing its ability to protect against UVA and UVB rays, low systemic absorption, and minimal risk of skin irritation. If the action is finalized, the ingredient would be recognized as safe and effective for use in adults and children 6 months and older, expanding consumer choice. The proposal follows a request from DSM Nutritional Products LLC and reflects broader efforts to streamline OTC drug regulation under the CARES Act. Bemotrizinol is already used internationally, and FDA is seeking public comment before issuing a final order.

Source:

(2025, December 11). FDA. FDA Proposes Expanding Sunscreen Active Ingredient List [Press Announcement]. https://www.fda.gov/news-events/press-announcements/fda-proposes-expanding-sunscreen-active-ingredient-list