FDA Approves Bemotrizinol, First New Sunscreen Filter in 25 Years
The FDA on Tuesday approved bemotrizinol, the first new sunscreen ingredient cleared for the U.S. market in more than 25 years, STAT News reported. The decision ends a long stretch in which American consumers had access to far fewer ultraviolet filters than people in Europe and Asia, where bemotrizinol has been used for years.
The ingredient, also known commercially as Tinosorb S, absorbs both UVA and UVB rays. Its arrival could give U.S. manufacturers a new tool to formulate broad-spectrum products, an area where domestic options have lagged because of the slow regulatory path for sunscreen actives.
Sunscreen ingredients in the U.S. are regulated as over-the-counter drugs, which has made approvals far slower than the cosmetic-style review used abroad. The bemotrizinol clearance signals movement on a backlog that dermatologists and industry groups have pressed the agency to address, potentially opening the door for additional filters already common overseas.
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