FDA authorizes bemotrizinol for use in OTC sunscreens, the first new UV filter added to the U.S. sunscreen monograph in over 20 years, under the streamlined CARES Act framework.
Written By: Sana Khan, BPharm
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration (FDA) has authorized bemotrizinol for use in over‑the‑counter (OTC) sunscreens, marking the first new UV filter added to the U.S. sunscreen monograph in more than 20 years. The decision, finalized under the streamlined Coronavirus Aid, Relief, and Economic Security (CARES) Act order process, represents a landmark update to U.S. sunscreen regulation and consumer access.
Streamlined Pathway Under CARES Act
The CARES Act allows FDA to modify OTC monographs through administrative orders rather than traditional rulemaking, creating a more efficient pathway for reviewing nonprescription drug ingredients.
DSM Nutritional Products LLC submitted the OTC Monograph Order Request seeking authorization of bemotrizinol at concentrations of up to 6%. FDA issued a proposed order on December 12, 2025, followed by a public comment period that closed on January 26, 2026. After reviewing the submitted data and public feedback, the agency finalized the order within seven months.
The action establishes an important regulatory precedent and may help accelerate future reviews of sunscreen ingredients under the updated OTC framework.
Scientific Evidence Supports Authorization
FDA’s decision followed a comprehensive scientific review of bemotrizinol’s safety and efficacy. The agency evaluated data submitted through the monograph request, including two independent human clinical efficacy studies, nonclinical research, clinical pharmacology data, clinical safety studies, and evidence from independent literature reviews. Based on this assessment, FDA concluded that bemotrizinol is effective as a sunscreen active ingredient at concentrations up to 6% and has an acceptable safety profile for use in adults and children aged six months and older.
Authorized for OTC Sunscreen Use
FDA concluded that bemotrizinol is generally recognized as safe and effective (GRASE) for use in adults and children six months of age and older. The agency cited low levels of systemic absorption through the skin and evidence supporting the ingredient’s safety and effectiveness.
Manufacturers can now formulate OTC sunscreen products containing bemotrizinol at concentrations up to 6%, provided they comply with all applicable monograph requirements.
Broad-Spectrum Protection with Global Experience
Bemotrizinol is a broad-spectrum UV filter that protects against both ultraviolet A (UVA) and ultraviolet B (UVB) radiation, which contribute to sunburn, premature skin aging, and skin cancer risk.
The ingredient has been used in Europe and numerous other countries for decades, providing extensive real-world safety and performance experience. Its authorization addresses long-standing concerns that U.S. consumers have had access to fewer modern sunscreen filters than consumers in many international markets.
Market and Innovation Impact
Federal health officials described the decision as an example of how updated regulatory processes can improve access to scientifically supported consumer health products.
Health and Human Services Secretary Robert F. Kennedy Jr. noted that bemotrizinol’s long history of safe use abroad could increase consumer confidence while expanding competition in the U.S. sunscreen market. FDA leaders emphasized that the review was guided by current scientific evidence while maintaining established standards for safety and effectiveness.
Karen Murry, M.D., Director of FDA’s Office of Nonprescription Drugs, said the agency’s updated framework allows innovative products like bemotrizinol to reach consumers more efficiently while maintaining rigorous safety standards.
Market Implications
With the final order now in effect, sunscreen manufacturers can begin incorporating bemotrizinol into OTC formulations that meet monograph requirements.
The decision may encourage additional applications for UV filters that are widely available internationally but have not yet reached the U.S. market, potentially expanding sunscreen innovation and consumer choice while maintaining FDA’s safety and efficacy standards.
Reference
FDA Expands Sunscreen Options for the First Time in 20 Years | FDA
About the Writer
Sana Jamil Khan (LinkedIn) is a B. Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.