FDA Expands Sunscreen Options for the First Time in 20 Years

FDA Takes Action to Expand Available Sunscreen Ingredients

The U.S. Food and Drug Administration has announced a significant milestone in sunscreen regulation by expanding the list of permitted sunscreen active ingredients for the first time in more than 20 years.

The action adds bemotrizinol as an approved active ingredient for use in over-the-counter sunscreen products, providing manufacturers with an additional option for broad-spectrum UV protection.

According to FDA, bemotrizinol offers protection against both UVA and UVB radiation, demonstrates low skin absorption, and has been evaluated through the agency’s review process under the Sunscreen Innovation Act framework.

Why This Matters

Sunscreen products in the United States are regulated as over-the-counter (OTC) drugs. As a result, the introduction of new active ingredients requires FDA review and approval to ensure safety and effectiveness.

The addition of bemotrizinol is notable because it represents the first expansion of the FDA-approved sunscreen active ingredient list in more than two decades. The ingredient has been used in sunscreen products in numerous international markets and is recognized for its broad-spectrum UV filtering capabilities.

Potential Impact on Industry

The action may provide sunscreen manufacturers with additional formulation flexibility while expanding available options for consumers.

Potential benefits include:

• Greater flexibility in developing broad-spectrum sunscreen products
• Access to an additional UV filter already used in global markets
• Opportunities for product innovation within the sunscreen category
• Expanded options for achieving UVA and UVB protection goals

Companies involved in sunscreen, cosmetics, personal care products, and OTC drug development may wish to evaluate how the addition of bemotrizinol could affect future formulation strategies.

Continued Focus on Sunscreen Modernization

FDA has stated that the action supports broader efforts to modernize sunscreen regulation while maintaining established standards for safety and effectiveness.

The announcement also reflects ongoing industry interest in expanding access to sunscreen technologies that have been available in other regions of the world.

EAS Perspective

The addition of bemotrizinol represents an important regulatory development for sunscreen manufacturers and product developers. Beyond the introduction of a new active ingredient, the action signals continued movement toward modernization of the U.S. sunscreen regulatory framework.

Companies developing sunscreen and personal care products should monitor future FDA actions and guidance related to sunscreen ingredients, labeling, and product development.