FDA has received reports of adverse reactions to some temporary skin-staining products. The following information is intended to respond to questions about the safety and legality of such products.

 

Temporary tattoos, such as those applied to the skin with a moistened wad of cotton, fade several days after application. Under the law, color additives used in them must be approved by FDA for use on the skin.

FDA has received reports of allergic reactions to some decal-type temporary tattoos. An Import Alert is in effect for several foreign-made temporary tattoos. The temporary tattoos subject to the import alert are not allowed into the United States because they contain colors not permitted for use in cosmetics applied to the skin or they don't have the required ingredient declaration on the label.

 

Henna, a coloring made from a plant, is approved only for use as a hair dye. It is not approved for direct application to the skin, as in the body-decorating process known as mehndi. This unapproved use of a color additive makes these products adulterated and therefore illegal. An Import Alert is in effect for henna intended for use on the skin.

 

Because henna typically produces a brown, orange-brown, or reddish-brown tint, other ingredients must be added to produce other colors, such as those marketed as "black henna" and "blue henna." Even brown shades of products marketed as henna may contain other ingredients intended to make them darker or make the stain last longer on the skin.

 

So-called "black henna" may contain the "coal tar" color p-phenylenediamine, also known as PPD, which is only permitted for use as a hair dye. In some cases, the so-called "black henna" consists only of hair dye, which the artist mixes straight from the package and applies to the customer's skin.  

 

PPD and some other hair dye ingredients may cause reactions in some individuals. That's the reason hair dyes have a caution statement and instructions to do a "patch test" on a small area of the skin before using them.

 

FDA has received reports of injuries to the skin from products marketed as henna and products marketed as "black henna."

 

 

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.

 

 

By law, all color additives used in cosmetics must be approved by FDA for their intended uses, with the exception of coal tar colors intended for use in hair dyes. In addition, some color additives must not be used unless FDA has certified that the batch meets the regulatory requirements for composition and purity. Cosmetics, including temporary tattoo products, that do not comply with restrictions on color additives are considered adulterated and are illegal in interstate commerce. To learn more, see Color Additives and Cosmetics.

 

 

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 or environmental concerns. Importantly, cosmetic products and ingredients are required to be safe for consumers under labeled or customary conditions of use. Companies and individuals who manufacture or market cosmetics have a legal responsibility for the safety of their products. FDA can take action against cosmetics on the market that violate the law.

 

 

If you have concerns about temporary tattoos or any other cosmetic, please contact MedWatch, FDA’s problem-reporting program, on the Web or at 1-800-332-1088; or contact the consumer complaint coordinator in your area.