FDA won't enforce name change for sunscreens.* The Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) announced it will not take enforcement action against sunscreen sunscreen /sun·screen/ (-skren) a substance applied to the skin to protect it from the effects of the sun's rays. sun·screen n. manufacturers who could not re-label products with the required name changes by Sept. 1. The name changes are required for four active ingredients: meradimate for methyl anthranilate, octinoxate for octyl methoxycinnamate octyl methoxycinnamate /oc·tyl meth·oxy·cin·na·mate/ (ok´til me-thok?se-sin´ah-mat) octinoxate. , octisalate for octyl salicylate and ensulizole for phenylbenzimidazole sulfonic acid Phenylbenzimidazole sulfonic acid (C13H10N2O3S) is a common sunscreen agent. In 1999, the United States Food and Drug Administration regulated that the name ensulizole be used on sunscreen labels in the United States. . The agency stated enforcement discretion, "is appropriate to avoid the need for drug manufacturers and distributors to incur extraordinary expenses in implementing the labeling changes immediately or to cease marketing certain drug products whose labeling cannot be changed in a timely manner." The agency said the technical amendment has no impact on the statutory requirement to comply with the name changes. |
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