FDA Considers Approval of Advanced European Sunscreen Filter Bemotrizinol

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The United States Food & Drug Administration (FDA) is evaluating the addition of bemotrizinol, a chemical sunscreen filter widely used in Europe, to the list of approved ingredients for American consumers. This potential change comes amid growing scrutiny of existing US sunscreen standards and a desire to align domestic products with more advanced European formulations.

Why This Matters: A Gap in Protection

Currently, the FDA recognizes only zinc oxide and titanium dioxide as “Generally Recognized As Safe and Effective” (GRASE) sunscreen actives. Many common chemical filters, like oxybenzone and avobenzone, are under review for potential long-term health risks, leaving a gap in effective UVA protection. Bemotrizinol offers broader-spectrum coverage, particularly against long-wave UVA rays, which penetrate deeper into the skin and are strongly linked to skin cancer development.

What Experts Say: Superior Performance and Stability

Dermatologists are optimistic about the proposed change. According to Joshua Zeichner, MD, of Mount Sinai Hospital, bemotrizinol “provides broader protection against UV light” than many existing US filters. Unlike some current options, it is also photostable – meaning it doesn’t degrade rapidly in sunlight – potentially reducing the need for frequent reapplication.

Ife J. Rodney, MD, of Eternal Dermatology Aesthetics, highlights that bemotrizinol may be particularly beneficial for those with sensitive skin, as it is less likely to cause irritation. Gary Goldenberg, MD, adds that the ingredient “plays well with other sunscreen ingredients,” allowing for higher SPF ratings at lower concentrations.

The FDA’s Path Forward: Modernizing Regulation

The FDA has acknowledged the need to modernize sunscreen regulation, stating that Americans “deserve timely access to the best safe, effective, and consumer-friendly” products. The agency is now initiating a public comment period before finalizing approval for bemotrizinol.

The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad.

Long-Term Implications: Fewer Skin Cancers, Better Protection

If approved, bemotrizinol could contribute to a significant reduction in skin cancer rates, including melanoma. Dermatologists anticipate the ingredient’s wider availability will empower consumers with more effective tools for sun protection. The move is seen as a long-overdue step toward bringing US sunscreen standards in line with global best practices.

“This is excellent news and long overdue… We have been stuck in the past, while the rest of the world enjoys superior formulas.” – Gary Goldenberg, MD