FDA Adds Bemotrizinol to OTC Sunscreen Monograph, First New Ingredient in Over 20 Years

The FDA's final administrative order adding bemotrizinol to the OTC sunscreen monograph signals the first substantive test of the CARES Act streamlined process, and sets a procedural benchmark that OTC drug manufacturers should map against their own monograph order strategies. The agency finalized the action within seven months of issuing the proposed order on December 12, 2025, a timeline that compresses what had previously been a multi-decade bottleneck in OTC ingredient authorization.

Bemotrizinol, submitted by DSM Nutritional Products LLC, is permitted at concentrations up to 6 percent as a sunscreen active ingredient. FDA reviewed the request, issued a proposed order, accepted public comment through January 26, 2026, and has now issued the final order, completing the full administrative order cycle under 21 CFR-aligned OTC monograph reform. The ingredient carries a GRASE designation for adults and children six months and older, covering both UVA and UVB protection with documented low dermal absorption.

For regulatory affairs leads, the procedural architecture here is the more consequential development. Under the pre-CARES Act framework, adding a new active ingredient to an OTC monograph required rulemaking that routinely stretched across decades, bemotrizinol itself had been in regulatory limbo in the U.S. while remaining in active commercial use across European markets for years. The administrative order pathway, by contrast, allows FDA to act on an OTC monograph order request from a drug company and move through proposal, comment, and finalization within a defined cycle.

Plant heads and QA directors preparing sunscreen formulations with bemotrizinol will need to confirm that finished product labeling, concentration controls, and in-process testing align with the conditions established in the final order. Because OTC monograph drugs enter the market without an approved drug application, compliance with monograph conditions, permitted active ingredients, uses, concentrations, and doses, constitutes the primary regulatory control point. Any deviation from those conditions shifts the product outside monograph coverage and into NDA territory.

The seven-month proposed-to-final timeline will serve as a reference point as additional OTC monograph order requests move through the pipeline, with FDA's Office of Nonprescription Drugs indicating intent to apply the same science-driven, administratively efficient approach to future submissions.

Source: U.S. Food and Drug Administration press release via FDA.gov, June 9, 2026.