FDA Approves New Sunscreen Ingredient After 20 Years: My Experience

In a significant update for skincare enthusiasts, the U.S. Food and Drug Administration (FDA) has approved bemotrizinol as a new sunscreen ingredient. This marks the first new active sunscreen ingredient to be authorized in the United States in over two decades.

The Benefits of Bemotrizinol

Bemotrizinol, a chemical UV filter, has been widely used in European and Asian sunscreen products for years. Its effectiveness stems from its ability to provide broad-spectrum protection against both UVA and UVB rays. Unlike many existing sunscreen ingredients in the U.S., bemotrizinol does not leave a white cast on the skin, making it a desirable option for consumers.

• Non-greasy texture: Many users praise it for its light, non-sticky feel upon application.
• Compatibility: It synergizes well with other sunscreen ingredients, allowing for lighter and more pleasant formulations.
• Stability: Bemotrizinol is more photostable than many other chemical ingredients, ensuring longer-lasting protection.
• Safety: It is expected to be recognized as safe and effective, alongside zinc oxide and titanium dioxide, the only current GRAS (Generally Recognized as Safe) sunscreen ingredients in the U.S.

Comparing Formulations

Products like Bioré UV Aqua Rich Watery Essence, popular in Asian markets, offer a glimpse into bemotrizinol’s potential. Dermatologists have highlighted the stark differences between this formulation and its U.S. counterpart, which lacks the same efficacy and texture.

Why Approval Took So Long

The review process for sunscreens in the U.S. is notoriously rigorous. Unlike in many countries where sunscreens are considered cosmetics, the FDA classifies them as drugs, which requires extensive testing for safety and efficacy. The last new ingredient was approved in 1996.

The approval of bemotrizinol became possible following the pandemic relief CARES Act of 2020, which streamlined the approval process for over-the-counter drugs, provided they meet safety standards. Given bemotrizinol’s long history of safe use in other countries since 2000, its approval was a logical step for the FDA.

The Future of Sunscreens in the U.S.

While the FDA’s decision on bemotrizinol is still pending finalization, experts anticipate that consumers can expect new and innovative sunscreen products on the market by the end of 2026. This could herald a new era of more effective and agreeable sunscreen formulations for the American public.