2001; Updated September 18, 2006
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.
What about "decal"-type temporary
Temporary tattoos, such as those applied
to the skin with a
moistened wad of cotton, fade several days after application. Many
contain color additives approved for cosmetic use on the skin. However,
FDA has received reports of allergic reactions to some temporary
import alert is in effect for several foreign-made temporary tattoos.
According to Consumer Safety Officer Allen Halper of FDA's Office of
Cosmetics and Colors, the temporary tattoos subject to the import alert
are not allowed into the United States because they don't have the
required ingredient declaration on the label or they contain colors not
permitted for use in cosmetics applied to the skin.
What about henna, or mehndi?
Henna, a coloring made from a plant, is
approved only for use as a
hair dye, not 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.
FDA has received reports of injuries to the skin from products marketed
Since henna typically produces a brown,
reddish-brown tint, other ingredients must be added to produce other
colors, such as those marketed as "black henna" and "blue henna."
So-called "black henna" may contain the "coal tar" color
p-phenylenediamine, also known as PPD. This ingredient may cause
allergic reactions in some individuals. The only legal use of PPD in
cosmetics is as a hair dye. It is not approved for direct application
to the skin. Even brown shades of products marketed as henna may
contain other ingredients intended to make them darker or make the
stain last longer.
In addition to color additives, these
skin-decorating products may contain other ingredients, such as
How do I know what's in a temporary
tattoo or henna/mehndi product?
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
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
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
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."
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. You can use the contact information in Your
Guide to Reporting Problems to FDA.