U.S. FDA Approves Bemotrizinol as First New Sunscreen Ingredient in 20 Years
The U.S. Food and Drug Administration (FDA) announced on October 25, 2023, that it has approved bemotrizinol as an active ingredient in sunscreens, marking the first addition to the list of approved filters in the United States in over two decades, according to the FDA’s official statement.
What is Bemotrizinol?
Bemotrizinol, a chemical UV filter, has been used in European sunscreens for decades and offers broader protection against UVA radiation compared to many existing U.S. filters, according to the FDA. It is classified as photostable, meaning it remains effective when exposed to sunlight, and is less likely to irritate sensitive skin, as noted by dermatologists. The ingredient also absorbs UV light across a wider spectrum, including long-wave UVA rays, which are linked to deeper skin penetration and higher skin cancer risk, explained Dr. Joshua Zeichner, director of cosmetic and clinical research at Mount Sinai Hospital in New York City.
Why This Matters for Sun Protection
The approval addresses a long-standing gap in U.S. sunscreen formulations. Currently, the FDA recognizes only two mineral filters—zinc oxide and titanium dioxide—as Generally Recognized As Safe and Effective (GRASE). Chemical filters like oxybenzone and avobenzone are under safety review, with ongoing debates about their long-term effects. Bemotrizinol’s low absorption rate and photostability place it in the GRASE category, according to the FDA, making it a safer option for widespread use.
What Dermatologists Are Saying
Dermatologists across the U.S. have welcomed the decision. Dr. Gary Goldenberg, a board-certified dermatologist in New York City, called the move “long overdue,” highlighting that European sunscreens have long incorporated more advanced, lightweight formulas. Dr. Ife J. Rodney, founder of Eternal Dermatology Aesthetics, emphasized that bemotrizinol’s compatibility with other ingredients could enhance SPF effectiveness at lower concentrations, reducing potential irritation.
“This will mean fewer skin cancers, including melanomas, which are potentially fatal,” said Dr. Zeichner, who added that the ingredient’s gentler profile could benefit patients with sensitive skin. The FDA’s approval is expected to align U.S. sunscreen standards with those of Europe, where bemotrizinol has been a staple for years.
When Will Bemotrizinol Be Available?
While the FDA’s announcement was recent, sunscreen manufacturers have been preparing for its inclusion, according to the agency. FDA Commissioner Dr. Marty Makary stated in a prior statement that “Americans deserve timely access to the best safe, effective, and consumer-friendly over-the-counter products available.” However, no specific timeline for product availability has been released. Dr. Zeichner, for his part, said he would “be the first in line to purchase it” once available.
How to Stay Protected in the Meantime
In the interim, dermatologists recommend using sunscreens containing zinc oxide or titanium dioxide, which are currently approved and effective. For those seeking chemical filters, products with avobenzone should be used cautiously, as the FDA continues its safety review. Experts also emphasize reapplication every two hours and using broad-spectrum formulas with an SPF of 30 or higher.