Implications of the FDA's Proposal to Expand Sunscreen Ingredients

The FDA has proposed adding bemotrizinol to the list of permitted sunscreen ingredients — the first substantive ingredient update in more than 20 years. Clinically, the change expands formulation options and brings U.S. sunscreens closer to international standards for broad-spectrum protection.

Bemotrizinol is a long-wave UVA/UVB organic filter that provides broad-spectrum coverage with notable photostability. In combination formulations, it acts as a stabilizer, helping preserve efficacy across UVA and UVB wavelengths without rapid degradation. Allowing bemotrizinol in U.S. regulations would give formulators flexibility to mirror international filter combinations, potentially producing products that sustain UV protection during longer exposures while improving cosmetic acceptability and wearability.

Widely used in European and Asian markets, bemotrizinol's post-market experience supports its role as a combination filter. Regulators and formulators note that adding a stabilizing filter can reduce reliance on higher concentrations of individual filters, which may enhance cosmetic acceptability and adherence.

The American Academy of Dermatology Association has welcomed the proposal, and its support signals professional endorsement for broader ingredient access. Current clinician guidance remains focused on daily use of a broad-spectrum sunscreen with SPF 30 or higher, prompt reapplication after swimming or heavy sweating and at least every two hours during prolonged outdoor exposure, plus complementary measures such as protective clothing and shade. These counseling points remain the cornerstone of patient guidance.

The United States currently lags behind many regions that permit additional sunscreen filters. Narrowing that gap could enable higher-performance U.S. formulations, including combinations that employ smaller-particle filters for improved aesthetics, enhanced photostability for longer effective wear, and stronger water-resistance for real-world use. Such formulation advances would broaden choices for patients seeking long-lasting, cosmetically acceptable protection.

The regulatory pathway—from proposal to public comment to a final rule—will determine timing and scope; review timelines vary, and label updates, stability testing and manufacturing scale-up can add months to years before broad product availability.

Key Takeaways:

• What’s new: The FDA proposal would permit bemotrizinol, expanding formulation options and aligning U.S. markets closer to international standards.
• Who’s affected: Patients seeking long-lasting, cosmetically acceptable broad-spectrum sunscreens and clinicians advising on product selection; formulators could introduce combination filters with improved photostability.
• What changes next: Expect a public comment period and a potential multi-year pathway to product availability; in the meantime, continue emphasizing daily SPF ≥30, regular reapplication, and protective behaviors, and monitor regulatory progress for expanded ingredient availability.