Text Size A A

After decades of delay, the Food & Drug Administration issued a final regulation today that will for the first time require manufacturers to test and label sunscreens for both UVA and UVB protection. The rule allows manufacturers to label sunscreens that pass FDA's test for UVA and UVB protection as "broad spectrum," and it requires warning labels on sunscreens that do not pass the test.

Manufacturers are currently required to label sunscreens with an SPF number, which indicates how much protection they provide against UVB radiation, the primary cause of sunburn. But consumers have had no way of knowing whether sunscreens will protect them from UVA rays, the leading cause of skin cancer and premature skin aging.

Under the new rule, sunscreens that meet FDA's broad spectrum standard will be allowed to make the claim that they reduce the risk of skin cancer and early skin aging. Those that do not pass the test must indicate that they do not reduce such risks.

The rule also prohibits manufacturers from using misleading labels such as sunblock, waterproof, or sweatproof, but they can use the label "water resistant" if they include information on the label regarding how long water resistance lasts. In addition, the rule forbids manufacturers from claiming that sunscreens are effective for more than 2 hours unless they submit evidence to FDA to prove it. The new labels will be required beginning in the summer of 2012 for products made by companies with annual sales of $25,000 or more. All other companies will have two years to comply with the regulation.

Consumer groups and some members of Congress who have been urging FDA to strengthen sunscreen regulations for years called the announcement a victory for consumers. "These new sunscreen standards are going to give consumers better, more accurate information," Sen. Jack Reed (D-RI), said in a statement. "By next summer, products that don't meet these standards will be taken off the shelves, or exposed for offering inadequate protection."

FDA also released a proposed rule today to limit the maximum SPF number on sunscreens to 50. "We don't have sufficient evidence to show that sunscreen with SPF values higher than 50 provide greater protection for the consumer," Janet Woodcock, director of FDA's Center for Drug Evaluation & Research, explained during a briefing today. Under the proposed rule, sunscreens with higher SPF values would be labeled 50+.

In addition, FDA announced that it intends to propose a regulation to examine the safety and effectiveness of spray sunscreens. The agency is particularly concerned about the potential for inhalation of aerosols.

FDA is continuing to study the safety and effectiveness of sunscreen ingredients that are currently on the market, particularly those that contain nanoscale titanium dioxide and zinc oxide. But the latest evidence suggests that nanoparticles do not penetrate the skin, Woodcock said at today's briefing.