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The Food and Drug Administration (FDA) is amending its list of permissible sunscreen ingredients for the first time in more than 25 years.
On Tuesday, the federal health agency signed off on allowing bemotrizinol to be added to sunscreen products after it met the FDA’s standard for protecting against dangerous ultraviolet rays and causing little irritation or absorption into the skin, according to the Associated Press.
This addition gives Americans access to a skin-protecting chemical that has been historically used in Europe and other parts of the world.
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Bemotrizinol will initially be sold in the U.S. as Parsol Shield, manufactured by Dutch company DSM Nutritional Products, expected to launch later in 2026, the AP reported. The ingredient will be available for use by other manufacturers after an 18-month exclusivity period.
DSM (the sunscreen ingredient company) submitted a format request for the FDA to approve bemotrizinol as a new sunscreen ingredient in the U.S., allowing its use in over-the-counter sunscreens at concentrations up to 6%.
In a December press release announcing the proposal of this request, the FDA noted that bemotrizinol is “generally recognized” as safe and effective for adults and children 6 months and older.
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FDA Commissioner Marty Makary, MD, MPH, commented in a statement that the agency has “historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad.”
“We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products,” he said in the release. “Americans deserve timely access to the best safe, effective and consumer-friendly over-the-counter products available.”
In the same news release, Karen Murry, MD, acting director of the Office of Nonprescription Drugs in Maryland, commented that bemotrizinol “would be a welcome addition to the current array of effective sunscreen active ingredients already available to American consumers.”
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“We look forward to working with other companies on bringing products containing other new active ingredients to market for a wide array of conditions in multiple therapeutic areas, in a much more timely fashion than was possible in the past,” she added.
The FDA continues to regulate sunscreen products to ensure that they meet safety and effectiveness standards, while encouraging the public to use numerous protective measures.
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This includes using broad-spectrum sunscreens SPF 15 or higher to help reduce the risk of skin cancer and signs of aging, along with wearing protective clothing and limiting time in the sun.
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