June 14, 2011 -- Sunscreen labels will carry a "broad spectrum" label to show they offer some protection against UVA radiation as well as UVB radiation, according to a long-awaited new rule from the FDA.
"This is a very significant day for us. The FDA is announcing major changes in how sunscreens are regulated in the U.S.," Janet Woodcock, MD, director of the FDA center for drug evaluation, said at a news conference. "This will allow people to make better decisions and better protect themselves from sun-induced damage."
Products currently labeled as "broad spectrum" may or may not protect against UVA. The new rule reserving the "broad spectrum" claim only for products that protect against UVA and UVB will not take effect until the summer of 2012.
The old "SPF" designation still will show how well a product protects against UVB rays. But products with the new "broad spectrum" label will have to pass a test showing that they protect against UVA, too. The higher the SPF level on these broad-spectrum sunscreens -- up to SPF 50 -- the better they protect against both UVA and UVB.
UVB radiation is responsible for sunburn and plays a major role in causing skin cancer. It affects only the outer layer of the skin. UVA, while less intense than UVB, is 30 to 50 times more prevalent than UVB and penetrates to deeper layers of the skin. UVA is the dominant tanning ray and is closely linked to skin aging. It also damages skin DNA and causes skin cancer.
The "broad spectrum" designation carries a lot less specific information about UVA protection than the zero-to-four-star system the FDA originally proposed in 2007. But the FDA finally decided only to insist that UVA protection must increase as the SPF value goes up.
New Information on Sunscreen Labels
Also new to sunscreen labels will be a clear message stating how long water-resistant sunscreens maintain protection after a person swims or sweats. Labels will specify either 40 or 80 minutes of protection. Those that aren't water resistant will have to carry a warning to that effect.
Sunscreen labels now will be able to claim that a product protects against skin cancer if it has an SPF rating of 15 or higher. And the product can claim to protect against sun-related premature skin aging if it has the broad-spectrum designation.
However, products will not be allowed to claim they "block" the sun or that they prevent skin cancer or aging. They also can't say they last for more than two hours, unless proof of longer protection is submitted to the FDA.
Like other over-the-counter drugs, sunscreens will now carry a "drug facts" box on the back or side of the container. Within the box will be any appropriate safety warnings. For example, sunscreens with an SPF under 15 will have to warn that they do not protect against skin cancer.