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U.S. FDA standardizes sunscreen labelling laws

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Sunscreen products are under the scanner once again.

The U.S. Food and Drug Administration has come up with a clear-cut requirement which says that sunscreen products sold in the United States and Canada will now be expected to follow a uniform labelling system that specifies which products offer the best protection and bans terms like ‘sunblock’ and ‘waterproof’.

Under the new system, only sunscreen products that protect against both ultraviolet B (UVB) and ultraviolet A (UVA) radiation, and have an SPF of 15 or higher, will qualify to be labelled as ‘broad spectrum’.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation, said the term will indicate that a product offers proven protection on multiple levels.

“Sunscreens that meet the new test for broad spectrum protection and also are SPF 15 or above can for the first time include the statement: ‘Using as directed reduces the risk of early skin aging and skin cancer when used with other sun protection measures,'” Woodcock told a news conference.

Conversely, sunscreen products that do not meet the FDA’s new standards will be required to include a warning on the label.

“Sunscreen that is not broad spectrum or is broad spectrum but is lower than SPF 15 will have to carry a warning statement saying it has not been shown to prevent skin cancer or early skin ageing,” Woodcock said.

The labelling rules will be in place no later than 2012, but may begin to appear earlier than that, she said.

The FDA is also banning use of the word ‘sunblock’ by sunscreen manufacturers, because it gives a incorrect impression of the protection offered by the product.

Woodcock said no sunscreen product will be allowed to carry an SPF value higher than 50 “because we don’t have sufficient data that sunscreens with SPF values higher than 50 provide greater protection.”

The FDA is also banning the use of the words ‘waterproof’ and ‘sweat-proof’ and says that sunscreen products claiming to be water-resistant must indicate how long the sunscreen remains effective, when exposed to water.

Finally, Woodcock said sunscreen products can no longer be described as offering protection for two hours or longer, and all products must include a drug fact box.

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