Beachgoers reaching for the sunscreen this summer may notice some new labels on the bottles, including warnings that the product may not protect against skin cancer.
This is the first summer that the Food and Drug Administration’s rules for over-the-counter sunscreen labeling are in full effect. Labels will now feature information about whether the products protect against both UVA and UVB rays; whether they help prevent sunburn, skin cancer and premature aging; and if and for how long they are water-resistant.
A group of nine senators, however, wants the FDA to do much more. Although the agency has finalized many of the regulations it proposed in 2011, it has yet to complete them all — including rules regarding spray sunscreens and sunscreens advertising SPFs of 50 or higher. SPF stands for sun protection factor.
“We urge you to do more to ensure that consumers can purchase sunscreen products and products containing sun protection with the knowledge that they meet the FDA’s enforceable standards and offer the strongest possible protection,” the senators wrote in a recent letter to FDA Commissioner Margaret A. Hamburg.
The lawmakers emphasized that the new labeling rules are necessary to educate consumers and protect them against skin cancer. The National Cancer Institute estimates that this year more than 76,000 people will be diagnosed with melanoma, the most dangerous form of skin cancer, and almost 9,500 will die from it.
According to the American Cancer Society, more than 2 million of the skin cancers diagnosed each year could be prevented by protecting against sun exposure and avoiding indoor tanning.
The FDA’s new labeling rules are already a big change for sunscreen manufacturers. They can no longer promote their products as “waterproof” or “sweatproof” or say they provide “instant protection” without FDA approval. In addition, products that don’t offer broad-spectrum coverage or have an SPF above 15 must carry alerts that they do not prevent skin cancer or premature skin aging.
The final regulations became effective in June 2012, but the FDA postponed compliance dates for most sunscreen products until December 2012 to avoid a potential shortage last summer — a delay the lawmakers criticized.
Although the senators praised the agency for enforcing those regulations this summer, they pushed the agency to do more. They asked Hamburg to strengthen labeling by finalizing a proposed regulation that would require sunscreen products with SPF values of more than 50 to be labeled as “50+.”
The FDA has said there is insufficient data to show that products with SPFs of more than 50 provide greater protection against the sun than products with SPF 50 — and the senators agree.
“For instance, one product with an SPF of 30 was found to protect against 97 percent of the sun’s UVB rays, while a product labeled with an SPF of 100 may protect against 98 percent of the sun’s rays,” they said in the letter.
Dec. 10, 2013, 6:14 p.m.
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Dec. 10, 2013, 4:37 p.m.