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FDA Rules & Regulations for Sunscreen

The Food and Drug Administration (FDA) is taking steps to help protect consumers from skin damage caused by excessive sun exposure.

The measures include the following:

• final regulations that establish standards for testing the effectiveness of sunscreen products and require labeling that accurately reflects test results
• a proposed regulation that would limit the maximum SPF value on sunscreen labeling to “SPF 50+”
• a data request for safety and effectiveness information for sunscreen products formulated in certain dosage forms (e.g., sprays)
• a draft guidance for sunscreen manufacturers on how to test and label their products in light of these new measures.
• These measures are necessary, says Lydia Velazquez, PharmD, in FDA’s Division of Nonprescription Regulation Development, because “our scientific understanding has grown. We want consumers to understand that not all sunscreens are created equal.”

“This new information will help consumers know which products offer the best protection from the harmful rays of the sun,” Velazquez says. “It is important for consumers to read the entire label, both front and back, in order to choose the appropriate sunscreen for their needs.”

Everyone is potentially susceptible to sunburn and the other detrimental effects of exposure to UV radiation.

FDA's Final Regulations

The final regulations, which become effective June 18, 2012, establish a standard test for over-the-counter (sold without a prescription) sunscreen products that will determine which products are allowed to be labeled as “Broad Spectrum.”

However, to avert a shortage of sunscreen in the upcoming months, FDA has extended the compliance dates for testing and labeling until Dec. 17, 2012 for most over-the-counter sunscreen products. This decision followed a review of timelines and other data submitted by trade associations representing sunscreen manufacturers.

“With summer coming, we wanted to ensure we had sunscreen products available on store shelves for everyone,” says Velazquez.

Products that pass the broad spectrum test will provide protection against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA). 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.

Under the new regulations, sunscreen products that protect against all types of sun-induced skin damage will be labeled "Broad Spectrum" and “SPF 15” (or higher) on the front.

The new labeling will also tell consumers on the back of the product that sunscreens labeled as both “Broad Spectrum” and “SPF 15” (or higher) 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. For these broad spectrum products, higher SPF (Sun Protection Factor) values also indicate higher levels of overall protection.

By contrast, any sunscreen not labeled as “Broad Spectrum” or that has an SPF value between 2 and 14, has only been shown to help prevent sunburn.

Reynold Tan, a scientist in FDA’s Division of Nonprescription Regulation Development, notes that FDA has been developing testing and labeling requirements for sunscreen products for decades. However, only recently have the data become sufficient to establish an accurate and reliable test for broad spectrum UV protection, he says.

To help consumers select and use sunscreens appropriately, 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.

FDA Proposed Regulations, Data Requests, and a Draft Guidance
In addition to the final regulations, in June 2011 FDA proposed a regulation that would require sunscreen products that have SPF values higher than 50 to be labeled 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.

FDA also requested data and information on different dosage forms of sunscreen products. The agency currently considers sunscreens in the form of oils, creams, lotions, gels, butters, pastes, ointments, sticks, and sprays to be eligible for potential inclusion in the OTC sunscreen monograph – meaning that they can be marketed without individual product approvals.

The agency currently considers wipes, towelettes, powders, body washes, and shampoo not eligible for the monograph. Therefore, they cannot be marketed without an approved application.

For sunscreen spray products, the agency requested additional data to establish effectiveness and to determine whether they present a safety concern if inhaled unintentionally. These requests arose because sprays are applied differently from other sunscreen dosage forms, such as lotions and sticks.

In addition, FDA issued a draft guidance to help sunscreen manufacturers understand how to label and test their products in light of the final and proposed regulations and the data request on dosage forms.

FDA has received numerous comments on the labeling proposal, draft guidance and requests for data. The agency is currently evaluating the data and information included in these comments.

Sun Safety Tips
Spending time in the sun increases the risk of skin cancer and early skin aging. To reduce this risk, consumers should regularly use sun protection measures including:

• 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.
• This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Updated May 17, 2012 - www.fda.gov 

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