FDA seeks more detailed sunscreen labels
WASHINGTON -- Sun lotions should be required to carry new ratings letting consumers compare for the first time how well the products guard against a form of skin-damaging ultraviolet rays, US regulators said.
Labels for sunscreens would display as many as four stars to indicate their effectiveness against the sun's UVA rays, the Food and Drug Administration said in a rule proposed yesterday. The products also would include a new warning saying ultraviolet rays from the sun increase skin cancer risks.
Consumer groups have called for the FDA to require sunscreens to specify how well they shield against UVA radiation because many now make imprecise claims such as "Extra UVA protection." The ratings would appear along with the SPF, or sun protection factor, numbers already used to measure how well the lotions fend off sunburn caused by another type of ultraviolet ray.
"It provides some consistency and reliability to the claims that are being made," said Richard Wiles, executive director of the Environmental Working Group, an advocacy organization that has studied sunscreens. "Manufacturers make claims about UVA, but you have no idea what it really means."
US sales of sunscreens were $650 million last year, according to Kline & Co., a Little Falls, N.J., market research firm. The proposed rules would affect products sold without a prescription, such as Coppertone, made by Schering-Plough Corp., and Hawaiian Tropic, from Playtex Products Inc.
The FDA is seeking public comment before adopting the rules. To give manufacturers time to test products and craft new labels, the regulations would go in effect about two years after adoption of the regulations.
The agency proposal also includes standards for claims that can be made on labels such as those dealing with water resistance.
Lawmakers and advocacy groups faulted the agency for failing to propose labeling standards sooner. The agency published rules in 1999 and put them on hold. The FDA then missed a deadline imposed by Congress to adopt new labeling guidelines by last year.