Sunscreens made by Merck & Co., Energizer Holdings Inc. and Johnson & Johnson will have to pass a test from U.S. regulators before they can be labeled as protection from skin cancer under a new rule.
Starting next year, only sunscreens shown to protect against both ultraviolet A and B rays with SPF values of 15 or higher may be marketed as reducing the risk of cancer and early skin aging, the Food and Drug Administration said today. The agency proposed banning SPF values higher than 50 because of insufficient data that they provide greater protection.
More than 2 million people were treated for skin cancer in 2006, according to the American Cancer Society. Lawmakers have urged the FDA for more than a decade to revise sunscreen labels to address cancer-causing UVA rays that penetrate deeper into skin cells and aren’t blocked by window glass.
“Twenty percent of Americans will develop skin cancer in their lifetime,” said Ronald L. Moy, president of the American Academy of Dermatology, in a press conference today at FDA headquarters in Silver Spring, Maryland. “Ultraviolet exposure is the most preventable risk factor for skin cancer.”
SPF, or sun protection factor, refers to a product’s ability to deflect UVB rays that cause sunburn. The rating reflects the amount of time it will take skin to turn red; sunscreen rated SPF 15 will provide 150 minutes of protection for someone who normally burns in 10 minutes.
Companies will be able to use simple lab tests to demonstrate that their UVA and UVB protection is proportional, the FDA said. Some existing products probably meet the standard already, according to Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research.
Sunscreens that fail the test for UVA and UVB rays or have an SPF value of less than 15 must carry a new warning that they haven’t been shown to prevent skin cancer or early skin aging.
Companies will be prohibited from using the phrases “waterproof” or “sweat proof;” claims of “water resistant” will be allowed based on test results. The phrase “sun block” will also be banned because it implies the sunscreens work better than has been proven, Woodcock said.
The FDA has considered changes to sunscreen labeling since 1978. The agency proposed in 2007 to rank UVA protection with an illustration of one to four stars. Many of the almost 3,000 people who submitted feedback to the plan said it was too confusing, according to Woodcock.
“While my preference for the labeling rule would have been a clear graphic indicating whether a product offers UVA protection, this is clearly a step in the right direction,” said Representative Nita Lowey, a New York Democrat, in an e-mailed statement today.
The FDA will accept comments for 90 days on the proposal to ban SPF values higher than 50. Several products on the market now claim to protect to SPF 100 or higher.
Higher demand for Coppertone sun-care products helped Whitehouse Station, New Jersey-based Merck generate $1.3 billion in sales of consumer products last year, according to the company’s annual report. Merck acquired Coppertone in its $49 billion acquisition of Schering-Plough in November 2009.
Energizer Holdings’ Banana Boat and Hawaiian Tropic brands together hold a leading market share in the U.S., according to the company’s annual report for the fiscal year ended Sept. 30.
Annual sales increased 10 percent and have climbed for the past five years because of increased consumer awareness of skin damage from the sun, an aging population and more convenient sprays, the St. Louis-based company said in November.
J&J’s skin care business had $3.45 billion in sales last year, or 5.6 percent of revenue. The New Brunswick, New Jersey-based company sells Neutrogena and Aveeno sunscreens.
E-mail and voice-mail messages seeking comment from Merck, Energizer Holdings and J&J weren’t immediately returned.