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FDA Demands Correction On Sunscreen Label

October 11, 1990

WASHINGTON (AP) _ The Food and Drug Administration has told a sunscreen maker to stop claiming its products protect against a broad spectrum of the sun’s rays.

In an Oct. 5 letter released Thursday, the FDA told Schering-Plough Corp. officials to correct the labeling on ″Shade″ and any of its other sunscreen products by removing references to protection against ultraviolet A rays.

The UVA protection claim is unproven because there are no generally recognized testing procedures for determining UVA protection, the FDA said.

Schering-Plough includes on the labels of its ″Shade″ products the designation ″APP,″ the company’s UVA protection factor expressed as a percentage of the spectrum blocked by the sunscreens.

UVA rays are longer, less intense rays that are believed to contribute to cancer, wrinkles and other skin damage.

Ultraviolet B, or UVB, rays are the shorter, burning rays that cause sunburn and some skin cancers. These rays can be measured and are often expressed as a sun protection factor, or SPF.

The agency gave the company 10 days after receipt of the letter to advise the FDA what corrective measure had been taken. Otherwise, the FDA said it was prepared to take the matter to court.

Lewis Nolan, a spokesman for Schering-Plough HealthCare Products, said the company wants to meet with the FDA as soon as possible to discuss the issue.

″The company believes that FDA questions over the type of information communicated to consumers about UVA protection can be resolved to the satisfaction of all parties,″ he said.

In letters to several companies last February, the FDA warned sunscreen makers that claims of UVA protection were ″unsubstantiated, and therefore, unacceptable.″

UVA protection claims can give consumers a false sense of security, the FDA said, because sunbathers who believe they are adequately protected may stay out in the sun longer.

The only company the FDA allows to make UVA protection claims is Herbert Laboratories’ Photoplex. The product contains a new ingredient, which required it to undergo a more intensive effectiveness review by the FDA.