The principal display panel, i.e., the part of the label most likely displayed or examined under customary conditions of display for sale (21 CFR 701.10) and generally bearing the name of the product. It must identify by descriptive name or illustration the nature or use of the product and bear an accurate statement of the net quantity of contents of the cosmetic in the package in terms of weight, measure, numerical count, or a combination of numerical count and weight or measure. The declaration must be distinct, placed in the bottom area of the panel in line generally parallel to the base on which the package rests, and in a type size commensurate with the size of the container as prescribed by regulation.
The net quantity of contents statement of a solid, semi-solid or viscous cosmetic must be in terms of the avoirdupois pound and ounce, and a statement of liquid measure must be in terms of the U.S. gallon of 231 cubic inches and the quart, pint, and fluid ounce subdivisions thereof. If the net quantity of contents exceeds one pound or one pint, it must be expressed in ounces, followed in parenthesis ( ) by a declaration of the largest whole units (i.e., pounds and ounces or quarts and pints and ounces). The net quantity of contents may additionally be stated in terms of the metric system of weights or measures.
The name and place of business of the firm marketing the product must be stated on an information panel of the label (21 CFR 701.12). The address must state the street address, city, state, and zip code. If a firm is listed in a current city or telephone directory, the street address may be omitted. If the distributor is not the manufacturer or packer, this fact must be stated on the label by the qualifying phrase "Manufactured for ..." or "Distributed by ..." or similar, appropriate wording.
The Tariff Act of 1930 (19 U.S.C. 1304) requires that all imported articles state on the label the English name of the country of origin. See also 19 CFR 134.
All label statements required by regulation must be in the English language
and must be placed on the label or labeling with such prominence and conspicuousness
that they are readily noticed and understood by consumers under customary
conditions of purchase (21 CFR 701.2).
Declaration of Ingredients
Cosmetics produced or distributed for retail sale to consumers for
their personal care are required to bear an ingredient declaration (21
CFR 701.3). Cosmetics not customarily distributed for retail sale, e.g.,
hair preparations or makeup products used by professionals on customers
at their establishments or skin cleansers made available to persons at
their place of work, are exempt from this requirement provided these products
are not also sold to consumers at professional establishments or workplaces
for their consumption at home.
The ingredient declaration must be conspicuous so that it is likely to be read at the time of purchase. It may appear on any information panel of the outer con-tainer, i.e., an information panel of the folding carton, box or wrapping if the immediate container is so pack-aged or, if not packaged in an outer container, an information panel of the jar, tube or bottle containing the product. The ingredient declaration may also appear on a tag, tape or card that is firmly affixed to the outer container. The letters must not be less than 1/16 of an inch in height (21 CFR 701.3(b)). If the total package surface available to bear labeling is less than 12 square inches, the letters must not be less than 1/32 of an inch in height (21 CFR 701.3(p)). Off-package ingredient labeling is permitted if the cosmetic is held in tightly compartmented trays or racks, it is not enclosed in a folding carton, and the package surface area is less than 12 square inches (21 CFR 701.3(i)).
The ingredients must be declared in descending order of predominance. Color additives (21 CFR 701.3(f)(3)) and ingredients present at one percent or less (21 CFR 701.3(f)(2)) may be declared after the ingredients present at concentrations exceeding one percent without regard for predominance. The ingredients must be identified by the names established or adopted by regulation (21 CFR 701.3(c)); those accepted by the FDA as exempt from public disclosure may be stated as "and other ingredients" (21 CFR 701.3(a)).
Cosmetics which are also drugs must first identify the drug ingredient(s)
as "active ingredients(s)" before listing the cosmetic ingredients (21
CFR 701.3(d)).
Label Warnings
Cosmetics which may be hazardous to consumers when misused must bear
appropriate label warnings and adequate directions for safe use. The statements
must be prominent and conspicuous. Some cosmetics must bear label warnings
or cautions prescribed by regulation (21 CFR 740). Cosmetics in self-pressurized
containers (aerosol products), feminine deodorant sprays and, children's
bubble bath products are examples of products requiring such statements.
For more information, see The FDA Cosmetic Handbook.