JUN 2019

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Page 71 of 96

© GETTY IMAGES NEW FDA PROPOSALS On February 21, 2019, the FDA released a proposed rule aimed at increasing the safety and effi cacy of over-the-counter (OTC) sunscreens, and to help the agency fi nalize regulations as required by the Sunscreen Innovation Act of 2011. Public comments were to be submitted by the end of May. "The FDA made some major recommendations," says Robert Manzo, cosmetic chemist and founder of Skinprint, a manufacturer of physician-dispensed skin care and sunscreens. Here are the primary issues addressed. SUNSCREEN ACTIVES: There are 16 UV protectant actives approved for use in the U.S. The FDA made—for the fi rst time—a distinction between ingredients it considers "generally recognized as safe and effective" (GRASE) and those it doesn't. "Zinc oxide and titanium dioxide are the only actives considered GRASE for use in sunscreens. The FDA is saying that two other ingredients, PABA and trolamine salicylate, aren't GRASE and aren't to be used," says Manzo. He clarifi es that this doesn't mean other ingredients aren't safe and effective, nor that PABA and trolamine are toxic or carcinogenic. "In terms of the other 12 actives, which are organic—or chemical—versus physical, the FDA wanted to look at them in more detail and asked manufacturers to provide more information on effectiveness and dosing," explains Manzo. "Regarding the two non-GRASE ingredients, the concern isn't that they're toxic; it's that they give rise to adverse effects when tested on the skin, including infl ammation, swelling and redness." © GETTY IMAGES June 2019 • 69

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