New Sunscreen Labels to Clarify Protection

The US Food and Drug Administration has released new guidelines requiring sunscreen manufacturers to label their products in more clear ways, a move which is sure to help parents choose the best sunscreens for their families.  Companies have until the summer of 2012 to implement the new labeling rules, which are meant to help consumers understand the difference between protecting themselves from sunburn and staving off premature aging and skin cancer.

Current sunscreens can claim to offer broad spectrum protection even if they don't do much against UVA rays -- the kind associated with wrinkling, age spots, and skin cancer. The sun protection factor, or SPF, number refers only to UVB rays, which cause sunburns and skin cancer. The new rules will require products to pass an FDA-specified test for UVA and UVB protection to make the claim "broad spectrum."

Any product that fails the test will have to carry a warning in a "drug facts" box on the back of the bottle stating that "this product has been shown only to prevent sunburn, not skin cancer or early skin aging." Products with an SPF lower than 15 will also have to carry that warning.

A sunscreen that both passes the broad spectrum test and has an SPF of 15 or higher can make the claim in the drug facts box that it "decreases the risk of skin cancer and early skin aging caused by the sun."

The American Academy of Dermatology applauded the new regulations. "For the first time, the FDA has clearly defined the testing required to make a broad-spectrum protection claim in a sunscreen and indicate which type of sunscreen can reduce skin cancer risk," said Dr. Ronald Moy, a dermatologist and president of the academy.

Products with an SPF of 15 -- which blocks 93 percent of UVB rays -- will have to provide the same proportional protection against UVA rays. "As the SPF number goes up," said Woodcock, "the UVA protection also has to go up." Thus, an SPF 30 product would be expected to provide more broad spectrum protection as well.

Dermatologists continue to recommend that people use products with an SPF of 30 or more because, Moy said, they often don't apply enough sunscreen -- the equivalent of at least a shot glass is recommended -- or reapply it often enough -- every two to three hours is best.

The new regulations don't allow for listing super-high SPFs like 80 or 90. Instead, these products can be described as having an SPF of "50 plus". "We have no evidence to show that going above an SPF 50 provides any additional benefits," [Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research] said.


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