FDA Announces New Sunscreen Rules in USA

Sunscreen Alone Isn't Enough

"This is really a remarkable day," Moy said at the news conference. "We thank the FDA for considering information submitted by AAD. Now we are glad there are consistent labeling instructions so the public can make informed decisions about sunscreens."

Moy and the AAD differ from the FDA on one point. The FDA recommends broad-spectrum, water-resistant sunscreens with an SPF of 15 or higher. The AAD recommends broad-spectrum, water-resistant sunscreens with an SPF of at least 30.

Moy stressed the importance of using plenty of sunscreen -- a golf ball-sized full ounce of sunscreen for a normal size adult body, reapplied every two hours.

Sunscreens alone are not enough to prevent skin cancer, Moy said. In addition to sunscreen, he recommends that people who go outdoors wear protective clothing and sunglasses and to seek shade whenever possible. And he strongly warns against the use of tanning beds.

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.
New Information on Sunscreen Labels continued...

These new rules will take effect by the summer of 2012, although Woodcock said some sunscreen makers may change their labels before that deadline.

A proposed new rule would prevent products from claiming an SPF factor higher than 50. The highest permitted rating will be "50+," because the FDA says there's no convincing data that SPF levels higher than 50 are meaningful. However, manufacturers will be given time to submit data on special populations that might benefit from sunscreens with SPF factors over 50.

The new rules are supposed to make it easier for people to buy and use sunscreens. But they raise a lot of questions. WebMD addresses these questions in an FAQ.

Spray Sunscreen Questioned

The FDA is asking the manufacturers of spray sunscreen products to prove how well the products work when used by consumers. There's concern that people may use too little of the products, thus failing to get the level of sun protection the label would lead them to expect.

Spray sunscreen makers also will have to prove there's no danger from accidentally inhaling the products while applying them to children and adults.

Consumer groups wanted a lot more from the FDA, which has been mulling the new sunscreen rules since 1978.

"It's now been 33 years since FDA first announced plans to implement safety standards for sunscreens," the Environmental Working Group said in a statement. "When FDA drags its feet for more than three decades to set up some standards for the sunscreen industry, it's clearly not the federal government's finest effort."

Consumers Union was more circumspect.

"Today’s announcement will take a lot of the guesswork out of reading sunscreen labels," Michael Hansen, PhD, Consumers Union senior scientist said in a statement. "The FDA’s introduction of a broad-spectrum test and associated labeling will require the sunscreen makers to first prove that their product provides such protection, and further, it will weed out the sunscreens that make broad spectrum claims without any evidence."

Many of the concerns over sunscreen involve the safety of their ingredients. Woodcock said the FDA has evaluated the available data.

"We are not at this time putting out any alerts or concerns," she said. "We feel some of these issues require further investigation. But at this time, the benefits of using sunscreens far outweigh the potential harms. People should use sunscreens if exposed to the sun."

Woodcock promised that if any ingredients are found not to meet FDA safety standards, the agency "will work with the manufacturers to remove the product from market."