FDA delays stricter sunscreen labeling rules

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The FDA has delayed new sunscreen labeling rules designed to help you protect your skin against the dangers of sun exposure. The rules, which were to take effect June 17, 2012, have been delayed six months to December 17, 2012, to give sunscreen manufacturers time to adapt their manufacturing, testing, labeling, marketing and sales processes.


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The new rules make major changes in how sunscreen products are labeled, to help consumers better determine the extent to which specific sunscreens will – or will not – protect their skin.

They require that all sunscreens offer “broad spectrum” protection against both ultraviolet A and B rays and have an SPF (sun protection factor) of at least 15, or else carry a warning label. That label will state: “This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”

Manufacturers will no longer be allowed to call their products “sunblock,” or to say they are “waterproof” or “sweatproof.” They also will not be allowed to claim to provide “all-day protection.” The FDA has determined those claims were overstated.

If a lotion or spray has an SPF of at least 15, its label can state that it protects against sunburn, early signs of aging and skin cancer. They can use the term “broad spectrum” if they protect against both ultraviolet A and B rays. Previous rules only addressed UVB rays and not UVA rays. Sunburn is primarily caused by UVB. Both UVB and UVA can cause sunburn, skin cancer, and premature skin aging. A certain percentage of a broad spectrum product’s total protection is against UVA.

Be aware that you will see some products in stores that already meet the new labeling requirements, while others are still operating by old rules until December 17.

According to the FDA, the final regulations include these additional labeling provisions:

  • Sunscreen products that are not broad spectrum or that are broad spectrum with SPF values from 2 to14 will be labeled with a warning that reads: “Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”
  • Water resistance claims on the product’s front label must tell how much time a user can expect to get the declared SPF level of protection while swimming or sweating, based on standard testing. Two times will be permitted on labels: 40 minutes or 80 minutes.
  • Manufacturers cannot make claims that sunscreens are “waterproof” or “sweatproof, or identify their products as “sunblocks.” Also, sunscreens cannot claim protection immediately on application (for example, “instant protection”) or protection for more than two hours without reapplication, unless they submit data and get approval from FDA.

In addition to the final regulations, FDA is proposing a regulation that would require any sunscreen products that have SPF values higher than 50 to be labeled simply as “SPF 50+.” FDA does not have adequate data demonstrating that products with SPF values higher than 50 provide additional protection compared to products with SPF values of 50.

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