FDA Sunscreen Ingredient Update: Bemotrizinol Added to the U.S. OTC Monograph

The First New FDA Sunscreen Ingredient Addition in More Than 20 Years

The U.S. Food and Drug Administration (FDA) has added bemotrizinol to the list of permitted sunscreen active ingredients, marking the first new FDA sunscreen ingredient addition to the OTC sunscreen monograph since the late 1990s.

The decision represents an important regulatory milestone for the U.S. sunscreen industry and may create new opportunities for product innovation in the years ahead.

What Is Bemotrizinol?

Bemotrizinol is a broad-spectrum UV filter that helps protect the skin from both UVA and UVB radiation. The ingredient has been widely used in Europe and other international markets for many years and is known for its photostability and effectiveness in sunscreen formulations.

According to the FDA, bemotrizinol is considered Generally Recognized as Safe and Effective (GRASE) for use in sunscreen products intended for adults and children six months of age and older.

Under the final order, the ingredient may be used at concentrations of up to 6%.

Why This FDA Sunscreen Ingredient Update Matters

For decades, the United States has had fewer permitted sunscreen active ingredients than many international markets. As sunscreen technology evolved globally, formulators often faced limitations when developing products specifically for the U.S. market.

The addition of bemotrizinol as a permitted FDA sunscreen ingredient expands the range of formulation options available to manufacturers and may help support future innovation within the category.

This change also reflects broader efforts by the FDA to modernize regulatory pathways for over-the-counter products while maintaining safety and efficacy standards.

The CARES Act and the New OTC Monograph Process

Another reason this FDA sunscreen ingredient update is significant is that bemotrizinol is the first new sunscreen active ingredient added through the streamlined OTC Monograph reform process established under the CARES Act.

Under this framework, qualifying OTC drug products can enter the market by complying with established monograph conditions rather than obtaining an approved New Drug Application (NDA).

The FDA reviewed scientific data, public comments, and industry feedback before issuing the final administrative order.

What This Means for K-Beauty Sunscreen Brands

Many Korean sunscreen manufacturers already have experience formulating products with bemotrizinol for international markets.

As the FDA sunscreen ingredient landscape continues to evolve, K-Beauty brands may find new opportunities to leverage existing formulation expertise when developing products for the U.S. market.

However, companies should remember that sunscreen products in the United States remain regulated as OTC drugs and must comply with applicable FDA requirements, including labeling, establishment registration, drug listing, and monograph conditions.

The Future of FDA Sunscreen Ingredient Innovation

The addition of bemotrizinol is more than a routine regulatory update. It signals a renewed focus on sunscreen innovation and highlights the potential for future modernization of the U.S. sunscreen framework.

While the long-term impact remains to be seen, this FDA sunscreen ingredient update represents an important step toward expanding formulation possibilities and aligning the U.S. market more closely with global sunscreen innovation trends.

For sunscreen brands, importers, and manufacturers, it is a development worth watching closely.

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