The U.S. Food and Drug Administration (FDA) announced a major step forward in sunscreen product development on December 13, 2025. The agency has proposed a rule to admit bemotrizinol as a legally permissible active ingredient in sunscreen formulations marketed in the United States. This regulatory action is part of the FDA’s larger initiative to foster innovation within the nonprescription drug sector.
What changed?
Bemotrizinol was previously unavailable in U.S. sunscreens, despite its widespread approval and use in other global markets. With this proposal, it may become the first new sunscreen active ingredient permitted in decades by the FDA under OTC Monograph Reform. The agency’s decision signals greater alignment between U.S. regulations and international standards, addressing limitations cited by manufacturers and researchers.
Scientific and regulatory details
Bemotrizinol is classified as a broad-spectrum UV filter, offering protection against both UVA and UVB radiation. Developed to meet stringent safety and efficacy standards, it is known for its chemical stability, long-lasting photoprotection, and minimal skin absorption. These traits have made it a staple in European and Australian sunscreen formulations.
Under the FDA’s proposed rule, bemotrizinol must undergo scientific review and comply with procedural requirements specified in the CARES Act framework. Manufacturers planning to incorporate it into sunscreens need appropriate documentation proving its performance aligns with Generally Accepted Safety Standards for OTC drugs. This includes clinical studies and detailed toxicology reports supporting human safety.
Impact on industry
The proposed inclusion of bemotrizinol has widespread implications for sunscreen producers and distributors. Companies aiming to formulate high-SPF and broad-spectrum products will gain access to a critical ingredient that improves sunscreen effectiveness. Regulatory professionals should prepare to navigate compliance pathways under updated FDA rules.
In addition, introducing bemotrizinol may encourage innovation across the skincare and personal care sectors in the United States. Effective communication of ingredient changes and safety testing successes will be essential for maintaining consumer trust.
Clinical, quality, and regulatory teams are encouraged to remain attentive to public comments and eventual final rulemaking timelines.
Frequently Asked Questions
1. What is bemotrizinol?
Bemotrizinol is a broad-spectrum UV filter used in sunscreens to block harmful UVA and UVB rays. It is widely approved outside the United States.
2. When will this proposal become final?
The FDA has invited public comments on the proposal before progressing to final rulemaking. Timelines depend on the scope and response to reviews.
3. How does this affect existing sunscreens?
Current sunscreen formulations are not directly impacted. However, manufacturers could choose to update product lines to include bemotrizinol following the rule’s finalization.
Conclusion
The FDA’s action to propose bemotrizinol as an approved sunscreen ingredient marks a significant step toward modernizing U.S. sunscreen regulations. Specialized teams in regulatory affairs should monitor ongoing updates and prepare for potential changes to compliance requirements. Continued adaptation to FDA-approved ingredients will remain crucial for product innovation and consumer safety.
Disclaimer
This article is for informational purposes only and does not constitute legal or regulatory advice. Always consult a qualified professional for compliance guidance.
FDA Announcement
For full information about the announcement, see the link below.