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FDA Issues New Rules on Sunscreens
Date:6/14/2011

By Steven Reinberg
HealthDay Reporter

TUESDAY, June 14 (HealthDay News) -- The U.S. Food and Drug Administration said Tuesday it will require new labeling for sunscreens to identify products that are best for reducing the risk of skin cancer, early skin aging and helping to prevent sunburn.

Under the new rule, sunscreens that protect against both ultraviolet A rays (UVA) and ultraviolet B (UVB) rays can be labeled "Broad Spectrum." UVB rays and UVA rays both can cause sunburn, skin cancer, and premature skin aging; UVB rays are the main source of sunburn, FDA officials explained.

The new rules will also require sunscreens to have a sun protection factor (SPF) of 15 or more or they won't be able to claim that they help prevent sunburn and possibly reduce the threat of premature skin aging and skin cancer -- if used with other measures to protect against the sun.

"Sunscreens that meet the new test for Broad Spectrum protection and are also SPF 15 or above can, for the first time, include the statement 'used as directed reduces the risk of early skin aging and skin cancer when used with other sun protection measures,' " Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation, said during a Tuesday morning news conference.

The new labels will, for the most part, not been seen until next summer, she said.

Sunscreens with a SPF of 2 to 14 can be labeled as "Broad Spectrum," but only those Broad Spectrum products with an SPF of 15 or more can claim they reduce the risk of skin cancer and early skin aging, according to the new regulation.

Any sunscreen that is not Broad Spectrum or a Broad Spectrum sunscreen with an SPF between 2 and 14 will have to carry a warning saying the product has not been found to prevent skin cancer or early skin aging.

Sunscreens labels will also have a "Drug Fact Box," Woodcock said. And, sunscreens can no longer be called sunblocks, she said, "because w
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