Written on: June 10, 2026 by SprayTM
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On June 9, 2026, the U.S. Food & Drug Administration (FDA) added bemotrizinol to the list of permitted sunscreen active ingredients; it is the first new active ingredient added to the over-the-counter (OTC) sunscreen monograph since the late 1990s.
FDA finalized this action within seven months of issuing the proposed order. The new ingredient has been marketed as a sunscreen ingredient in Europe and many countries around the world for years, according to the FDA, who further noted that bemotrizinol provides protection against both ultraviolet A and B rays and has low levels of absorption through the skin into the body. The FDA considers bemotrizinol to be generally recognized as safe and effective (GRASE) for use in sunscreens by adults and children six months of age and older.
An OTC monograph drug, such as a sunscreen product, can enter the market without an approved drug application if it meets certain requirements, including conditions established in its monograph such as permitted active ingredients, uses, and doses. The FDA can modify an OTC monograph through an administrative order, and a drug company may start the process by submitting an OTC monograph order request.
DSM Nutritional Products LLC submitted an OTC monograph order request to add bemotrizinol, at concentrations up to 6%, as a new active ingredient in the OTC monograph for sunscreens. The FDA reviewed the request and proposed to amend the OTC monograph to add bemotrizinol as a sunscreen active ingredient. The agency issued a proposed order on December 12, 2025, to this effect, and the public could submit comments from December 12, 2025 – January 26, 2026. The agency reviewed public comments on the proposed order and is now issuing the final order.
