- An identity statement, indicating the nature and use of the product, by means of either the common or usual name, a descriptive name, a fanciful name understood by the public, or an illustration [21 CFR 701.11].
- An accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure [21 CFR 701.13].
- Name and place of business. This may be the manufacturer, packer, or distributor. This includes the street address, city, state, and ZIP Code. You may omit the street address if it is listed in a current phone directory or city directory [21 CFR 701.12(a)].
- Distributor statement. If the name and address are not those of the manufacturer, the label must say "Manufactured for..." or "Distributed by...," or similar wording expressing the facts [21 CFR 701.12(c)].
- Material facts. Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded [21 CFR 1.21]. An example is directions for safe use, if a product could be unsafe if used incorrectly.
- Warning and caution statements. These must be prominent and conspicuous. The FD&C Act and related regulations specify warning and caution statements related to specific products [21 CFR part 700]. In addition, cosmetics that may be hazardous to consumers must bear appropriate label warnings [21 CFR 740.1]. An example of such hazardous products is flammable cosmetics.
- Ingredients. If the product is sold on a retail basis to consumers, even it it is labeled "For professional use only" or words to that effect, the ingredients must appear on an information panel, in descending order of predominance. [21 CFR 701.3]. Remember, if the product is also a drug, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling, as stated above. To learn more, see "Ingredient Names," "Color Additives and Cosmetics," "Fragrances in Cosmetics," and "'Trade Secret' Ingredients."
Declaration of Ingredients http://www.fda.gov/Cosmetics/Labeling/Regulations/ucm126438.htm#CosmeticsCosmetics 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 make-up products used by professionals on customers at their establishments and skin cleansing or emollient creams used by persons at their places 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 package, i.e., the folding carton, box wrapping if the immediate container is so packaged, and may also appear on a firmly affixed tag, tape or card. 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 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 ingredient(s)" before listing the cosmetic ingredients (21 CFR 701.3(d)).
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).
It is my recommendation that anyone making cosmetic products take the time to browse these pages for more information with regards to proper cosmetic labeling. Just being a small business does not exempt you from the law. The FDA fines small businesses as well as larger ones. The information contained within their website is informative and easy to follow.
is the link to the entire FDA Cosmetics Labeling Guide. This is a MUST read for
anyone making anything cosmetic. It includes the following: (this is
hyperlinked right to the FDA site.)
Available in PDF
Cosmetic Labeling Guide
The Cosmetics Labeling Guide provides step-by-step help with cosmetic labeling, with examples and answers to questions manufacturers often ask about labeling requirements under U.S. laws and related regulations.
On this page:
- Laws Regulating Cosmetic Labeling
- Legal Definitions of Terms
- Principal Display Panel
- Placement of Information on Labels
- Prominence and Conspicuousness
- Type Size
- Identity Labeling
- Name and Place of Business
- Net Quantity of Contents Declaration
- Warning Statements
- Ingredient Labeling
- Ingredient Identification
- Order of Declaration
- Fragrances and Flavors
- Trade Secret Ingredients
- Petitioning for Trade Secrecy
- Drug Ingredients
- Color Additives Added for Color Matching
- Incidental Ingredients
- Dissimilar Product Assortments
- Similar Product Assortments
- Branded Shade Lines
- Direct Mail Cosmetics
- Off-Package Ingredient Labeling
Happy Cosmetics Making!