The new regulations, which come into effect next year, will ban sunscreen manufacturers from claiming their products are waterproof or sweatproof because such claims are false, officials have said. Instead, manufacturers can claim, in minutes, the amount of time the product is water-resistant, depending upon test results.
The FDA says that sunscreens must protect equally against two kinds of the sun’s radiation — UVB and UVA — to be designated as offering “broad spectrum” protection. UVB rays cause burning, UVA rays cause wrinkling and both types cause cancer.
Sunscreens that have a sun protection factor, or SPF, of 15 or higher will be allowed to maintain that they help prevent sunburn and reduce the risks of skin cancer and early skin aging. Any sunscreen product that fails to offer proportional protection or has an SPF of 2 to 14 must include a warning that the product has not been shown to help prevent skin cancer or early skin aging. The new rules will standardize the testing that manufacturers must conduct for UVA protection.
“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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families.” “Most skin cancers are caused by sun exposure. FDA encourages consumers to protect themselves,” Woodcock added. “Not only should consumers regularly apply and reapply sunscreens with Broad Spectrum and SPF of 15 or higher, they should also limit sun exposure.”
The FDA is also proposing some additional changes that could affect sunscreens in the future. One proposal is to limit the maximum SPF on labels to “50+” because there isn’t enough information to prove that sunscreens with SPFs higher than 50 provide any greater protection for users.