Sunscreen Labeling to Warn against Danger from the Sun

FDA Consumer, September 1993 | Go to article overview

Sunscreen Labeling to Warn against Danger from the Sun


All sunscreen and suntan p would carry information about the sun's potential harm and the products' ability to protect users, under new labeling requirements proposed by FDA in the May 2, 1993, Federal Register.

One such statement proposed by the agency reads: "Sun Alert: The sun causes skin damage. Regular use of sunscreens over the years may reduce the chance of skin damage, some types of skin cancer, and other harmful effects due to the sun."

"There is overwhelming evidence that overexposure to radiation from the sun is a health hazard," said FDA Commissioner David A. Kessler, M.D. "Consumers should not have to guess how much protection, if any, they'll get from the sunscreen and tanning products on the market."

The agency proposed that SPFs (sun protective factors) be limited to a maximum of 30 and that cosmetic tanning products containing no sunscreen display a warning that they do not protect against sunburn. SPF numbers above 30 may be used until a final regulation becomes effective, but such values are not considered necessary for most consumers. (The higher the SPF number, the more protection is provided.)

The proposed labeling advises that products for children between 6 months and 2 years of age provide a minimum SPF of 4, and that parents consult a physician about using sunscreen on children younger than 6 months. …

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