The FDA has added bemotrizinol to the OTC sunscreen monograph, making it the first new sunscreen active ingredient added to the monograph since the late 1990s.

According to the FDA, bemotrizinol provides protection against both ultraviolet A and ultraviolet B radiation and has low systemic absorption following topical use. The agency considers the ingredient generally recognized as safe and effective for use in sunscreen products among adults and pediatric patients aged 6 months and older.

The action permits bemotrizinol as an active ingredient in OTC sunscreen products that meet monograph requirements; it does not constitute approval of a specific sunscreen product.

DSM Nutritional Products LLC submitted an OTC Monograph Order Request seeking to add bemotrizinol, at concentrations up to 6%, as an active ingredient in OTC sunscreen products. The FDA issued a proposed order on December 12, 2025, and accepted public comments through January 26, 2026. After reviewing public comments, the agency issued the final order within 7 months of publishing the proposed order. The FDA noted that bemotrizinol has been marketed as a sunscreen ingredient in Europe and many other countries for years prior to its U.S. authorization.

According to the FDA, bemotrizinol is the first new active ingredient added to an OTC monograph under the streamlined process established by the Coronavirus Aid, Relief, and Economic Security Act. Under the OTC monograph system, products may enter the market without an approved drug application if they meet monograph requirements, including permitted active ingredients, uses, and doses.

Source: FDA