The U.S. Food and Drug Administration (FDA) has added bemotrizinol to the list of approved active ingredients for over-the-counter (OTC) sunscreens, marking a significant update in sun protection options after two decades without new approvals.
What Happened
The FDA finalized its approval of bemotrizinol as an active ingredient in OTC sunscreens, the first new ingredient added since the late 1990s. Bemotrizinol has been widely used and considered safe in Europe and other countries for many years. The FDA issued the final order within seven months after proposing the addition in December 2025, following a public comment period.
Key Facts
- Bemotrizinol provides broad-spectrum protection against both UVA and UVB rays.
- The ingredient has low skin absorption and is considered generally recognized as safe and effective (GRASE) for use by children aged six months and older, as well as adults.
- This approval was granted under the streamlined OTC monograph process established by the CARES Act.
- DSM Nutritional Products LLC submitted the request to include bemotrizinol at concentrations up to 6 percent.
- The final FDA order followed review of public comments and scientific evaluation.
Why It Matters
This approval expands consumers’ sunscreen options with an ingredient already proven safe and effective internationally. It potentially improves competitive innovation in the U.S. sunscreen market, which has lagged behind other countries for decades. Enhanced protection options may help mitigate skin cancer risks associated with ultraviolet exposure.
Background
Since the late 1990s, no new sunscreen active ingredients have been added to the FDA’s OTC monograph. The U.S. process for approving new OTC sunscreen ingredients has been criticized for being slow and complex compared to systems in Europe and elsewhere. Bemotrizinol, long used abroad, was a candidate to modernize and diversify the U.S. sunscreen market.
Analysis
The expedited review and approval of bemotrizinol illustrate how recent regulatory reforms, including the CARES Act and the MAHA Strategy Report, aim to modernize FDA processes and accelerate access to new and safe OTC drugs. This development may signal future changes facilitating innovation in sunscreens and other nonprescription medications.
Who Is Affected
The approval impacts American consumers who will have access to sunscreens containing bemotrizinol, including adults and children over six months old. Manufacturers may now formulate products with this ingredient, potentially increasing variety and competition in the market.
Reactions / Official Statements
HHS Secretary Robert F. Kennedy, Jr. highlighted the approval as fulfilling a government commitment to advance sunscreen innovation. FDA officials emphasized the agency’s commitment to using sound science to ensure access to safe and effective OTC drugs. They praised the updated regulatory framework enabling quicker approval of new ingredients.
What Remains Unclear
This information was not confirmed in the reviewed sources: how rapidly sunscreen products containing bemotrizinol will reach the U.S. market and what impact this ingredient may have on consumer preferences and skin cancer outcomes over time.
What Comes Next
Companies may begin introducing sunscreens with bemotrizinol at allowable concentrations, offering additional protection choices. The FDA’s streamlined process may be used for future sunscreen innovations, potentially accelerating approvals of other new active ingredients.
Sources
This article is based on reporting and publicly available information from the following source:
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