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FDA: Proposal to include bemotrizinol in the OTC monograph
- Daniel Jiménez
- 4 hours ago
- 2 min read
The US Food and Drug Administration has published an administrative proposal to amend the Over-the-Counter (OTC) Monograph M020 for sunscreens and allow the use of bemotrizinol as an active ingredient in over-the-counter sunscreens in the United States. This initiative responds to a request from the industry and opens a new chapter in the evolution of sunscreens in the US market, where no new active ingredient has been added for more than two decades.
Table of contents
Bemotrizinol, BEMT or Tinosorb S
Bemotrizinol (also known internationally as BEMT or Tinosorb S) is a broad-spectrum, liposoluble organic sunscreen capable of absorbing UVA and UVB radiation. It is characterized by its high photostability and favorable safety profile, with low systemic absorption and minimal reported skin irritation. Available scientific data show that this compound has been widely used in sunscreen formulations outside the U.S. for years, and its inclusion aims to bring U.S. regulations closer to the standards observed in other developed markets.
The proposed amendment establishes specific conditions of use: bemotrizinol could be used at up to a 6% concentration and combined with other recognized active ingredients, provided that the final product meets the requirements of the OTC monograph, including efficacy testing and labeling according to current regulations.
If the regulation were adopted in its final form, bemotrizinol would be considered "Generally Recognized as Safe and Effective" (GRASE) for sunscreens intended for adults and children over six months of age, allowing its marketing without the need for individual drug approval.
Conclusion
This regulatory move is part of a broader FDA effort to modernize the monograph system for over-the-counter drugs—including sunscreens—and promote scientific innovation in sun protection formulations. Although the proposal remains open for public comment until January 2026, its progress has already generated interest among formulators and dermatologists, who see bemotrizinol as a tool for delivering more effective formulations with an improved sensory profile.
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