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HEALTH INDUSTRY JUNE 15, 2011

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Sharon Doyle puts sunscreen on the arm of9-year-old Savannah Stidham as they visit the beachin Fort Lauderdale, Fla.

By JENNIFER CORBETT DOOREN

The U.S. Food and Drug Administration released long-awaited sunscreen regulations Tuesday requiringproducts to pass certain effectiveness tests and adopt new labels designed to make it easier for consumers tochoose a sunscreen.

The SPF (sun-protection factor) number on sunscreens is currently based on how well and how long the productprotects against ultraviolet B (UVB) rays that primarily cause sunburn, not UVA rays. Both types of rayscontribute to wrinkles and skin cancer. The new regulations will require products that are labeled "broadspectrum"—as is the case with many currently marketed ones—to pass tests for both UVB and UVA rays.

Sunscreens that don't offer enough protection against UVB andUVA rays will be required to carry a warning label stating thatthe products haven't been shown to prevent skin cancer.

Although currently marketed "broad spectrum" sunscreens dooffer protection against UVA rays, there is currently nostandard.

"You can be labeled broad spectrum and have wimpy UVAprotection," explained Janet Woodcock, the head of FDA's drugdivision. Right now there's no way for consumers to tell howmuch UVA protection they are getting when they use a "broadspectrum" sunscreen.

Sunscreens that meet the new "broad spectrum" tests andreceive a SPF rating of 15 or higher will be allowed to state that they reduce the risks of skin cancer and signs ofearly skin aging if used as directed and in combination with other sun protection measures. Sunscreens thathave an SPF rating less than 15 will be required to carry a warning label saying the product hasn't been shown tohelp prevent skin cancer or early skin aging.

Large companies, including Merck & Co., which sells Coppertone, and Johnson & Johnson's Neutrogena unitwill have a year to make changes to product labels. Companies with annual sales of less than $25,000 will havetwo years to comply, the FDA said.

In 2007, the FDA had proposed a "star" rating system for sunscreens but that plan was dropped. Dr. Woodcocksaid that many of the 3,000 comments the agency received on the proposal said it was confusing.

She said the new rules are simple. Consumers looking for themost protection will be able to look for products that are labeled

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Sunscreens Get New Labeling Rules

FDA Sets New Labeling Rules for Sunscreens - WSJ.com http://online.wsj.com/article/SB1000142405270230466590457...

1 of 2 7/2/11 3:56 PM

The FDA issued new guidelines for sunscreensTuesday requiring products to pass certaineffectiveness tests and adopt new labels that make iteasier for consumers to choose a sunscreen. JenniferCorbett-Dooren reports.

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to help prevent skin cancer.

The rules will also require companies to drop terms like water-or sweat-proof and instead pass a test for water resistance tokeep a water claim on the label.

The FDA announced a separate proposal that would cap themaximum SPF value at "50+," on the grounds there aren'tenough data to show products with a value higher than 50 offersmore protection.

Rep. Nita Lowey, (D., N.Y.), who has been pushing the FDA toissue new sunscreen regulations for several years, said the new rules "are an important first step." She said shestill believes the products that offer appropriate UVB and UVA protection should carry some type of symbol,such as a star, so consumers can easily figure out which sunscreens help prevent skin cancer.

FDA Sets New Labeling Rules for Sunscreens - WSJ.com http://online.wsj.com/article/SB1000142405270230466590457...

2 of 2 7/2/11 3:56 PM