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FDA Proposes New Sunscreen Regulations



The U.S. Food and Drug Administration (FDA) has prposed new federal regulations on over-the-counter sunscreen products intended to help protect consumers from skin damage, including skin cancer, caused by over-exposure to sunshine.

The new regulations - scheduled to take effect in June 2012 - will require sunscreen makers to apply a standard test to determine which, if any, of their products cab legally be labeled as "Broad Spectrum," protecting against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA).

Also See:Federal Regulations: The Laws Behind the Acts

While sunburn is caused mainly by UVB radiation, both UVB and UVA can cause sunburn, skin cancer, and premature skin aging, according to the FDA.

Details of the New Regulations

Under the new regulations, only sunscreen products proven to provide protection against both UVB and UVA radiation can legally labeled "Broad Spectrum" and "SPF 15" or higher.

Sunscreen products labeled as "Broad Spectrum" and "SPF 15" (or higher) will indicate that the sunscreen will not only protect against sunburn, but, if used as directed with other sun protection measures, can reduce the risk of skin cancer and early skin aging.

Any sunscreen tested as providing SPF (sun protection factor) values below SPF 15 (SPF 2 to 14) will be required to display a label reading, "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."

Other new FDA sunscreen labeling regulations include:
  • "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."
    "This new information will help consumers know which products offer the best protection from the harmful rays of the sun," said FDA's Lydia Velazquez, PharmD, in a press release "It is important for consumers to read the entire label, both front and back, in order to choose the appropriate sunscreen for their needs."

    FDA Sun Safety Tips

    Whether using a sunscreen or not, the FDA has long advised people to follow these four tips to reduce the risk of sunburn, skin cancer and early skin aging.
    • Use sunscreens with broad spectrum SPF values of 15 or higher regularly and as directed.
    • Limit time in the sun, especially between the hours of 10 a.m. and 2 p.m., when the sun's rays are most intense.
    • Wear clothing to cover skin exposed to the sun; for example, long-sleeved shirts, pants, sunglasses, and broad-brimmed hats.
    • Reapply sunscreen at least every 2 hours, more often if you're sweating or jumping in and out of the water.
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