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Cosmetics including temporary skin-staining products that are sold on a retail basis to consumers must have their ingredients listed on the label. Without such an ingredient declaration, they are considered misbranded and are illegal in interstate commerce. FDA requires the ingredient declaration under the authority of the Fair Packaging and Labeling Act (FPLA).
Because the FPLA does not apply to cosmetic samples and products used exclusively by professionals--for example, for application at a salon, or a booth at a fair or boardwalk--the requirement for an ingredient declaration does not apply to these products.
Does FDA approve color additives?
By law, except for coal tar colors used in hair dyes, color additives used in cosmetics must be approved by FDA for their intended uses. Some may not be used unless FDA has certified in its own labs that the composition of each batch meets the regulatory requirements. Cosmetics--including temporary tattoo products--that do not comply with restrictions on color additives are considered adulterated and are illegal in interstate commerce.
Does FDA approve other cosmetic ingredients?
Except for color additives, FDA does not have the authority to approve cosmetic products or ingredients, although the use of several substances in cosmetics is prohibited or restricted due to safety concerns. However, if the safety of the product or its ingredients has not been substantiated, the product is misbranded--and therefore illegal in interstate commerce--if it does not have this warning on the label:
"Warning-The safety of this product has not been determined."
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How do I report an adverse reaction to a temporary tattoo or other cosmetic?
FDA encourages consumers to report any adverse reactions to cosmetics either to their nearest FDA district office or to FDA's Office of Cosmetics and Colors. Here's how:
* To contact your nearest FDA district office, you can find their phone numbers on FDA's Web site. These phone numbers also are included in the U.S. Government listings in the Blue Pages of the phone book under United States Government/Health and Human Services.
* To contact FDA’s Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS), call (301) 436-2405 or email CAERS@cfsan.fda.gov.