WASHINGTON - US regulators proposed Thursday a new labeling system for sunscreens in an effort to better inform consumers about how well a cream protects the skin against harmful sunrays.
The Food and Drug Administration (FDA) proposed standards for formulating, testing and labeling sunscreen products sold over the counter that provide ultraviolet A (UVA) and ultraviolet B (UVB) protection.
The proposals include a rating system for UVA protection on a scale of one to four stars, corresponding to low, medium, high and highest protection available in an over-the-counter sunscreen products.
If a sunscreen does not provide at least a one-star level of protection, FDA is proposing to require that the product bear a "no UVA protection" marking on the front label near the SPF value.
Sunlight is composed of the visible light and invisible ultraviolet light, of which there are two types: UVA light is responsible for tanning and UVB for sunburn. Both can damage the skin and increase the risk of skin cancer.
"For more than 30 years, consumers have been able to identify the level of UVB protection provided by sunscreens using only sunburn protection factor or SPF values," said FDA commissioner Andrew von Eschenbach.
SPF values refer to the time difference that ultraviolet light produces sunburn with and without sunscreen protection. An SPF of 15, for example, means the skin can bear 15 times the ultraviolet radiation before sunburn sets in.
"Under today's proposal, consumers will also now know the level of UVA protection in sunscreens, which will help them make informed decisions about protecting themselves and their children against the harmful effects of the sun," Von Eschenbach said.
The FDA proposal also revises existing SPF (UVB) testing procedures allowing new combinations of active ingredients, and also asking for comments on the issue of nanoparticles.
In addition, a "Warnings" statement in the "Drug Facts" box will be required of all sunscreen product manufacturers.
The warning will say: "UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen."
The FDA said the warning is intended to increase awareness that sunscreens are only one part of a sun protection program.
The FDA's proposals follow similar labeling regulations for sunscreen products adopted last month by the European Union.
08/23/2007 23:27 GMT