JUN 2019

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70 @dayspamagazine • June 2019 PROPER DOSING: The FDA also asked manufacturers to provide input on the percentage of actives used in their formulations. "In some cases, the FDA has specifi ed minimum and maximum levels for active ingredients," says Manzo, referring to the sunscreen monograph, which is the agency's standard of ingredients that covers dosage, labeling, indications, etc. "For the rest, you tend to see varying levels of actives from product to product. I'm sure that within three to fi ve years the FDA will create narrow dosage ranges for organic ingredients based on the feedback it receives." POWDERS VS. LIQUIDS: The proposed rule differentiated between liquid sunscreens—including sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks—and powder sunscreens. Powders may be eligible for the monograph, but fi rst the FDA wanted more data. Additionally, wipes, towelettes, body washes and shampoos that claim to offer UV protection may be categorized as new drugs, because the FDA doesn't have enough data for their inclusion in the monograph. "The FDA is saying that you can use these actives in sprays, lotions and gels because we know absorption rates for liquids. But when you put them into powders, there may be issues in terms of application and SPF protection, so we need more information," says Manzo. RAISING SPF LIMITS: The sunscreen monograph of 2011 limited SPF labeling claims to SPF 50+. This year, the FDA proposed raising the maximum value to SPF 60+. "A product with SPF 30 blocks about 95 percent of UV rays. For SPF 100, it's about 99 percent," says Larry MacPhee, general manager of physician-dispensed sunscreen and skincare manufacturer EltaMD. The initial cap of SPF 50 led to pushback from both industry and consumer groups, causing the FDA to propose the increase. "This is a big deal because it allows manufacturers to create more complex formulations and offer a diverse range of products. And it was due, in part, to consumer calls," says Manzo. "Now the FDA has said that yes, there is enough of a difference between SPF 50 and SPF 60 to have a real effect on skin health." BROAD SPECTRUM REQUIREMENTS: As of press time the proposed rule is still pending, but if it's fi nalized, all sunscreens with an SPF 15 value or higher must provide broad spectrum (UVA and UVB) protection, and the level of UVA protection must increase as the SPF level increases. TESTING CONSISTENCY: Currently, manufacturers use in-house and/or third-party labs to assess the safety and effi cacy of their sunscreen products. INGREDIENT BANS In 2018, Hawaii banned the sale of sunscreens containing oxybenzone and octinoxate due to concerns that they damage delicate coral reefs; Key West, Florida, followed suit in Januar y 2019. Although some in the sunscreen industr y dispute the risk, as the available research is inconclusive, the new legislation is affecting sunscreen formulation—namely the reworking of products to include actives in place of octinoxate. "Our goal is to provide sun protection that people are comfor table with and have confi dence using," says Larr y MacPhee, general manager of physician-dispensed sunscreen and skincare manufacturer EltaMD, who believes we'll see more of these regulations in the future. "I wouldn't be surprised if other oceanfront states adopt this kind of regulator y requirement, so formulators are getting ready by creating other options." BETTER PROTECTION © GETTY IMAGES

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