The US Food and Drug Administration has added bemotrizinol to its list of permitted sunscreen active ingredients, marking the first addition to the over-the-counter sunscreen monograph since the late 1990s. The final order was issued on 9 June 2026, just seven months after the proposed order was published.
Bemotrizinol has been used as a sunscreen ingredient in Europe and other markets for years. The FDA notes that it offers protection against both UVA and UVB radiation and exhibits low dermal absorption. The agency has classified it as generally recognised as safe and effective (GRASE) for adults and children aged six months and older.
The approval follows an OTC monograph order request submitted by DSM Nutritional Products LLC, which sought to add bemotrizinol at concentrations up to 6%. The FDA published its proposed order in December 2025 and accepted public comments through late January 2026 before issuing the final ruling.
Under the OTC monograph system, sunscreen products can reach market without a full drug application, provided they meet conditions set out in the relevant monograph — including approved active ingredients, permitted uses, and dosage requirements. Amendments to a monograph are made via administrative order, typically initiated by an industry submission.
The addition of bemotrizinol is expected to broaden formulation options for sunscreen manufacturers operating in the US market.
FDA approves bemotrizinol as first new sunscreen active ingredient in nearly 30 years
