FDA Approves Bemotrizinol Sunscreen Ingredient After 25-Year Gap in New Approvals
The approval reflects a shift in how the FDA evaluates cosmetic-style ingredients under updated regulatory pathways, with consumer access implications for a market that has long lagged behind...
The U.S. Food and Drug Administration has approved bemotrizinol as a new active sunscreen ingredient, marking the first such approval in approximately 25 years, according to an FDA announcement reported by Fox News on June 11, 2026. The chemical has been commercially available in sunscreen products sold in the European Union, Australia, and several Asian markets for decades, where it has been regulated under different cosmetic or drug frameworks than the United States applies.
Bemotrizinol is a broad-spectrum UV filter, meaning it absorbs both UVA and UVB radiation. The FDA's evaluation process for sunscreen active ingredients in the United States is governed by the Over-the-Counter (OTC) Monograph System, which was reformed under the CARES Act of 2020 (Public Law 116-136). That law created a new pathway — the OTC Monograph Order — allowing the FDA to update ingredient approvals without the full new drug application process previously required. The specific FDA order authorizing bemotrizinol has not yet been publicly linked to a docket number in available reporting; the full administrative record would be located in the FDA's OTC Monograph docket system at regulations.gov.
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Prior to this approval, eight UV filter ingredients that manufacturers had sought to add to the U.S. market — including bemotrizinol — had been under FDA review since at least 2019, when the agency issued a proposed rule identifying which existing sunscreen ingredients were recognized as safe and effective. That 2019 proposed rule, published in the Federal Register at 84 FR 6204, found only two ingredients — zinc oxide and titanium dioxide — to be fully recognized as safe and effective without additional data. Bemotrizinol was among the ingredients for which the FDA at that time said more safety data were needed.
The domestic sunscreen market is estimated by industry analysts to exceed $2 billion annually, though the specific market-share impact of bemotrizinol's approval on individual manufacturers is not yet determinable from public filings. Companies seeking to incorporate the new ingredient into commercial products will still be required to comply with FDA labeling requirements under 21 CFR Part 352 or successor OTC monograph orders, including SPF testing standards.
What remains unknown as of publication is the precise effective date of the FDA's bemotrizinol order, which formulation concentrations will be permitted, and whether any manufacturers have already submitted products for market under the new authorization. The full order, when published, will be accessible through the FDA's OTC Monograph database and the Federal Register, and would answer questions about permissible concentration ranges and any required post-market safety reporting conditions.