June 11, 2016 – fda.gov – FDA has received reports of adverse reactions to some “decal,” henna, and “black henna” temporary tattoos.
“Decal” Temporary Tattoos
Decal temporary tattoos are used to decorate any part of the body, including areas of the face and around the eyes, and may last for a day or up to a week or more. They are especially popular with children and at Halloween.
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There are two kinds of decal tattoos:
Some are images attached to a removable backing. The decal image is removed from the backing by wetting, and the image is then applied directly to the skin.
Others have a backing that adheres to the skin, creating a partial or complete barrier between the skin and the dyes used in the image.
The difference is important, because not all dyes are known to be safe for use on the skin. While an adhesive backing may protect the skin from unapproved colors, there may be other ingredients on or in the decal to help the image adhere better either to the backing or to the skin that may cause problems for some people.
FDA has received reports of reactions to some decal-type temporary tattoos. Before using a temporary tattoo on your face, it may be a good idea to try it on a less conspicuous part of your body.
Henna, or Mehndi, and “Black Henna”
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.
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.
Allergic reaction on a man’s hand. J. Cole/Photo Researchers.
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.
Allergic reaction on a 14-year-old girl. Dr. P. Marazzi/Photo Researchers.
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.”
Allergic reaction on an arm. Dr. P. Marazzi/Photo Researchers.
Finding out What’s in a Temporary Tattoo or Henna/Mehndi Product
Cosmetics 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 only 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.
FDA’s Authority over Color Additives in Cosmetics
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, and, for information on how color additives are approved, Color Additive Petitions.
FDA’s Authority over Other Cosmetic Ingredients
Cosmetics must be safe when consumers use them following directions on the label, or in the customary or expected way. Except for color additives, the law does not require cosmetic products and ingredients to have FDA approval before they are marketed. In addition, firms are not required to report their safety information, including complaints.
For a list of ingredients that are prohibited or restricted in cosmetics, see “Prohibited and Restricted Ingredients.”
For a list of color additives allowed in cosmetics, how they are allowed to be used, and links to their regulations, see “Color Additives Permitted for Use in Cosmetics.”
FDA Enforcement Action
FDA can take action against cosmetics on the market that don’t comply with the law. For example, we can issue Import Alerts and Warning Letters.
An Import Alert allows FDA to detain products that violate or appear to violate the Federal Food, Drug, and Cosmetic Act. We have two Import Alerts in effect for temporary tattoos. However, because not all shipments of imported cosmetics are inspected, it’s still possible for some unsafe or mislabeled products to be imported into this country.
An Import Alert is in effect for several foreign-made decal temporary tattoos because they contain colors not permitted for use in cosmetics applied to the skin, or they don’t have the required ingredient list on the label, or they are labeled as “FDA approved.”
An Import Alert is in effect for henna intended for use on the skin because it is an unapproved use of the color additive.
FDA issues Warning Letters to let companies know that they have violated the law and to tell them what corrective action they need to take. We have issued a Warning Letter to a company marketing “black henna” products: