On Tuesday, after 34 years of review, the Food & Drug Administration released its updated sunscreen monograph, one that will greatly affect how manufacturers make, market and label their sunscreen products and how consumers shop for these items.


The monograph, which is 174 pages long, addresses dozens and dozens of scientific sunscreen points, but a three-minute public announcement found on the FDA’s Web site delivers several top line nuggets to quickly outline to consumers what the monograph change means first and foremost.


In the announcement, consumers learn that beginning June 18, 2012, labels on sun care products (and all items that carry an SPF, such as cosmetics) that pass FDA’s broad-spectrum test procedure may be labeled as “broad spectrum” on packages. Only broad-spectrum sunscreens with an SPF 15 or higher can claim to reduce the risk of skin cancer and early signs of aging. Consumers are explained the difference between UVA and UVB broad spectrum rays and how not all sunscreens protect from both, as UVA rays are responsible for aging and cancer risks and UVB rays are tied to skin burning. Labels must also list whether the item is water resistant and for how long it is water resistant. Manufacturers may no longer list the words sunblock, waterproof or sweat proof on products, and sunscreens cannot say they last longer than two hours without reapplication. Items containing SPF must also clearly state drug facts on the side of the package, including cosmetics products with SPF, such as a lipstick.


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“There is no relief for small-sized packages and most makeup is under three ounces so there will be a lot of design rigmarole,” said Farah Ahmed, the chair of Personal Care Products Council Sunscreen Task Force.


“There are also serious concerns that there may be enough sunscreen. When you have to re-label an entire packaging line,” said Ahmed, it could be challenging. But she reminded that “anything labeled on or after June 18, 2012 has to comply” to the monograph, so current product can sell through next year if available.
Not mentioned in the announcement is what is still under debate, and that is the FDA proposed rule that would limit SPFs to 50, as no sufficient data has been found that items over SPF 50 work better than those with lower SPFs. FDA is open to public comment on this matter, and has no definite date when it will release a firm rule on SPFs over 50.


“This is the biggest conversation in the industry: whether items with SPF over 50 are still relevant in the marketplace. [FDA] wants more information about the clinical benefits between a SPF 50 and higher than 50. The extra amount of burn protection between 50 and higher [is minimal] but what these higher levels could mean for skin cancer and antiaging [isn’t known] so some companies want to continue to research this until the proposed rule is finalized,” said Ahmed.


Manufacturers of sunscreen products, overall, believe the monograph will help consumers get better protection from the sun, but also recognize that it will be a challenge to make the necessary packaging and marketing changes.


Coppertone, the leading suncare brand in the U.S., said it will collaborate with cross-functional internal teams as well as external partners and vendors to meet the new labeling rules set forth by the FDA and said all Coppertone products with an SPF of 15 or greater already meet the  newly announced 2012 standard for “broad spectrum” protection.


Maria Dempsey, executive vice president of marketing for Clarins, said, “For our business, it puts a lot of pressure because it’s a lot more difficult to market the product. You need to have much more strict testing, packaging is more stringent.” But Clarins will have it much easier than other manufacturers, she added, since they won’t have to discontinue any formulas and since they never claimed their formulas are waterproof. The company also “never believed in SPF above 50. Mostly our sku’s are between SPF 15 and SPF 50. We used to have [items] below SPF 15 but this year we made the decision to only have SPF 15 or above.”


Eric Bone, head of Research & Innovation for L’Oréal USA, which makes the La Roche-Posay skin care line, said the firm is in favor of capping SPFs at 50, however the subject “is really an industry level conversation,” one it will be participating in and listening to closely.


Johnson & Johnson Group of Consumer Cos., maker of Neutrogena and Aveeno sunscreens, issued a release stating it supports the efforts by the FDA but that it “continues to believe that SPF products over 50 provide additional sun protection for consumers and we have submitted data in support of our position. We believe that limiting labeling for SPF values higher than 50 may deter consumers from receiving the highest levels of sun protection.”


Beth St. Raymond, marketing director, Banana Boat and Hawaiian Tropic, said that the “new rules mainly affect the labeling of sunscreens, and will not require a change in most Banana Boat and Hawaiian Tropic brand sunscreen formulas [since] formulas with SPFs higher than 15 already meet the newly announced FDA requirements for providing safe and effective UVA and UVB protection. We will be implementing the new regulations on broad spectrum labeling in a timely manner.” In regard to the FDA proposal to set an SPF limit of 50, Energizer Personal Care believes that “products with SPFs higher than 50 provide a benefit to those people with a higher sensitivity to sun damage, and also because generally, people do not apply the proper amount of sunscreen. Not only would omitting products with SPFs higher than 50 limit consumers’ options, but it could inhibit the industry from innovating to develop new products with advanced protection.”


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