For the first time in 30 years, the Food and Drug Administration has issued new rules tightening standards on how the manufacturers of sunscreen can label their products and make claims about whether or not they are waterproof.
The FDA said the new rules, which go into effect June 2012, bring existing regulations up to date with the latest scientific data and safety standards.
“FDA has evaluated the data and developed testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and consumers can be well-informed on which products offer the greatest benefit,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a press release.
Under the new regulations, a sunscreen that passes FDA testing may call itself “broad spectrum” if it can protect consumers from both UVB (ultraviolet B) and UVA (ultraviolet A) light. If a product meets the standards for broad spectrum and is at least SPF 15, it may also claim to reduce the risks of skin cancer and early skin aging. Products that do not meet the broad spectrum standards, or are broad spectrum with an SPF between 2 and 14, must carry a warning that the product has not been shown to help prevent skin cancer or early skin aging, the FDA said.
In addition, manufacturers can no longer advertise sunscreen as “waterproof,” “sweatproof,” or “sun block.” Instead, labels can claim that products are “water-resistant” and work for a period of 40 minutes or 80 minutes, depending on test results. Products that are not water-resistant must now carry a warning to consumers to use a water-resistant product if they will be exposed to sweat or water.
And all sunscreens must now include a standard “Drug Facts” information box on the back or side of the container.
The agency also released a proposed rule that would limit the maximum SPF value on sunscreen labels to “50+,” as the FDA said that insufficient evidence currently exists to show that products with higher than 50 SPF provide greater protection. The agency said that manufacturers could submit data to support higher SPF values, however.
Still remaining on the agency’s radar: sunscreen sprays. The FDA released an advance notice of proposed rulemaking and requested information about the safety and effectiveness of sunscreen sprays, as well as comments on possible warnings for sprays.
To read the new rule, click here.
To read draft guidance for the industry, prepared by the FDA, click here.
Why it matters: While the new rules don’t take effect until next summer (with an exception for manufacturers with annual sales of less than $25,000, who have two years to comply), companies should begin to work toward compliance to be ready for the deadline.