Reading: FDA approves New Sunscreen Ingredient Bemt after 25-year wait

FDA approves New Sunscreen Ingredient Bemt after 25-year wait

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Federal health regulators on Tuesday approved bemotrizinol, the first new sunscreen ingredient for the U.S. market in more than 25 years, opening the door to products that can protect against both UVA and UVB rays. The decision also clears the way for to bring the ingredient to the United States under the brand name Parsol Shield later this year.

The approval matters now because Americans have waited decades for a meaningful update to sunscreen chemistry, even as the ingredient was already in use in Europe and elsewhere. , a senior scientist at the , said Americans have used outdated sunscreen technology for decades while the rest of the world moved forward, and added that the approval of bemotrizinol will help change that.

The Food and Drug Administration said bemotrizinol met its standards for protecting against dangerous ultraviolet rays while causing little irritation or absorption into the skin, and that it is safe for adults and children 6 months and older. Experts say the ingredient should help consumers find broad-spectrum protection without the white streaks associated with some mineral-based sunscreens. Under FDA rules, sunscreens must protect against both UVA and UVB rays.

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Bemotrizinol has been a long time coming. European authorities authorized it in 1999, and the ingredient first was filed with the FDA for review in 2005. Its approval on Tuesday also makes it the first ingredient to move through a streamlined process authorized by Congress in 2020, a path created to speed up changes that had been bogged down for years by the agency’s slow update system for over-the-counter drug ingredients.

That delay is the part of the story that still hangs over the approval. In 2011, the FDA banned terms like waterproof and required sunscreens to filter out UVA and UVB rays, and in 2021 it proposed additional measures, including capping SPF numbers and requiring stronger UVA protection. Yet the basic ingredient list barely changed, even though mineral-based ingredients such as zinc oxide can block both types of rays while leaving a chalky white residue.

DSM Nutritional Products is expected to launch Parsol Shield later in the year, and after an 18-month exclusivity period, other manufacturers will be able to use bemotrizinol as well. said the FDA is committed to ensuring Americans have access to the most effective and safe therapies, including over-the-counter products like sunscreens, and the next test is whether that promise reaches store shelves quickly enough for consumers to notice the difference.

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