FDA Opens the Door to Sunscreen Innovation:

First New UV Filter Approved in Over 20 Years!

The U.S. Food and Drug Administration (FDA) has finalized an administrative order adding bemotrizinol to the Over-the-Counter (OTC) Sunscreen Monograph, making it the first new sunscreen active ingredient approved for inclusion in the U.S. OTC sunscreen framework in more than two decades.

This landmark decision represents a significant advancement in sunscreen innovation and highlights the FDA’s ongoing efforts to modernize the OTC monograph process and expand consumer access to safe and effective sun protection products.

What is Bemotrizinol?

Bemotrizinol is a broad-spectrum ultraviolet (UV) filter that provides protection against both UVA and UVB radiation. The ingredient has been widely used in Europe and numerous international markets for many years and has demonstrated a strong safety profile with low systemic absorption through the skin.

Under the FDA’s final order, bemotrizinol is considered Generally Recognized as Safe and Effective (GRASE) for use in sunscreen products intended for adults and children aged six months and older. The ingredient may be used in OTC sunscreen formulations at concentrations up to 6%.

Regulatory Background

The addition of bemotrizinol follows an OTC Monograph Order Request (OMOR) submitted by DSM Nutritional Products LLC. After reviewing the submitted safety and efficacy data, the FDA issued a proposed order on December 12, 2025, followed by a public comment period. The agency has now completed its review and issued a final order authorizing the ingredient’s inclusion in the OTC Sunscreen Monograph.

Importantly, this is the first new sunscreen active ingredient added through the streamlined regulatory pathway established under the CARES Act, which modernized the process for updating OTC monographs and accelerated the review of innovative OTC products.

Why This Matters for Industry

For years, U.S. sunscreen manufacturers have operated with a limited range of approved active ingredients compared to other global markets. The addition of bemotrizinol provides manufacturers with greater formulation flexibility and access to a UV filter that has an established history of use internationally.

This action also signals the FDA’s commitment to modernizing the OTC regulatory framework and may encourage future innovation within the sunscreen and broader OTC drug sectors.

Key Takeaways

• Bemotrizinol is the first new active ingredient added to the OTC Sunscreen Monograph in more than 20 years.
• The ingredient provides broad-spectrum UVA and UVB protection.
• FDA considers bemotrizinol GRASE for use in adults and children six months of age and older.
• Sunscreen formulations may contain bemotrizinol at concentrations up to 6%.
• The approval was finalized through the OTC Monograph administrative order process established by the CARES Act.
• The decision may create new opportunities for product innovation and market expansion within the U.S. sunscreen industry.

How MDI Consultants Can Help

As regulatory requirements continue to evolve, manufacturers must carefully assess the impact of regulatory changes on product development, formulation, labeling, and market strategy. MDI Consultants Inc., provides comprehensive regulatory support for OTC drug and sunscreen manufacturers, including regulatory strategy development, OTC monograph compliance assessments, labeling reviews, ingredient evaluations, submission support, and FDA communications.

Whether you are developing a new sunscreen product, evaluating the use of bemotrizinol in an existing formulation, or seeking guidance on FDA regulatory requirements, our team can help navigate the process efficiently and effectively.

For assistance with OTC drug regulations, sunscreen compliance, or FDA market-entry strategies, contact MDI Consultants at info@mdiconsultants.com. Our regulatory experts are ready to support your product development and compliance objectives.