Sunscreen products sold on U.S. shelves -- and eventually products sold in Canada as well -- will soon be required to follow a standardized labelling system that specifies which products offer the best protection and bans the terms "sunblock" and "waterproof."
The U.S. Food and Drug Administration announced the new labelling requirements on Tuesday in Silver Spring, Md.
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 aging," Woodcock said.
The labelling rules will be in place no later than next summer, 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 false 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 requiring 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.
She said the FDA's new rules will, for the first time, standardize testing and labelling for sunscreen products sold across the U.S. The FDA has been under pressure to standardize labelling rules for sunscreen manufacturers for years.
The FDA announced back in 1978 it wanted to draft sunscreen regulations but didn't publish them until 1999. The agency then delayed finalizing the regulations for years, until now.
Here in Canada, Health Canada said Tuesday it's been in communication with the FDA about its changes and is planning changes of its own.
"Health Canada requires testing for UVB," it said in a statement. "Currently, the department is revising its Sunburn Protectants Monograph. This will include internationally acceptable test methods for UVA and UVB."
The revised Canadian monograph will reflect similar changes to those of the United States, the department said.
"Differences will remain in areas where there are different regulatory frameworks. For example, products that contain single ingredients, namely zinc oxide or titanium dioxide, will continue to be regulated as Natural Health Products," the statement said.
