Cosmetic Ingredient Labeling

Before proceeding with a discussion of labeling requirements, it is helpful to understand what key labeling terms mean:
Labeling Helps Consumers Make Informed Choices About Cosmetics

Proper labeling is an important aspect of marketing a cosmetic or personal care product. Labeling is used to help inform consumers of a product's intended use and any related warnings, its ingredients and net quantity of contents, and its place of manufacture or distribution. The U.S. Food and Drug Administration (FDA) regulates cosmetic labeling under the authority of both the Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA) . These laws and their related regulations are intended to protect consumers from health hazards and deceptive practices and to help consumers make informed decisions about the personal care products they purchase.Federal regulations require ingredients to be listed on cosmetic product labels in descending order of concentration. Because cosmetic ingredients are often complex chemical substances, the list may be incomprehensible to the product's average user. However, if the same name is used by all manufacturers, consumers can compare different products and make reasonable judgments about them.

  • Labeling: This term refers to all labels and other written, printed, or graphic matter on or accompanying a product [FD&C Act, sec. 201(m); 21 U.S.C. 321(m)].
  • Principal Display Panel (PDP): This is the part of the label most likely displayed or examined under customary conditions of display for sale [21 CFR 701.10].
  • Information Panel: Generally, this term refers to a panel other than the PDP that can accommodate label information where the consumer is likely to see it. The information on this panel must be prominent and conspicuous.

 

As part of the prohibition against false or misleading information, no cosmetic may be labeled or advertised with statements suggesting that the FDA has approved the product. This applies even if the manufacturing establishment is registered or the product is on file with FDA's Voluntary Cosmetic Registration Program .All labeling information that is required by U.S. law or regulation must be in English. The only exception to this rule is for products distributed solely in a U.S. territory where a different language is predominant, such as Puerto Rico. If the cosmetic's label contains any representation in a foreign language, all label information required under the FD&C Act must also appear in that language [21 CFR 701.2(b)].

The following information must appear on the Principal Display Panel
  • An identity statement , indicating the nature and use of the cosmetic 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].

 

The following information must appear on an Information Panel:
  • Distributor statement: If the name and address are not those of the manufacturer, the label must say "Manufactured for..." or "Distributed by..." [21 CFR 701.12].
  • 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 cosmetic product has the potential to be misused.
  • 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]. Flammable cosmetics such as aerosols are an example of products that require specific warnings.
  • Ingredients: If a cosmetic product is sold on a retail basis to consumers, even if 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]. If the product is also an over-the-counter (OTC) drug, its labeling must comply with the FDA regulations for both OTC drug and cosmetic ingredient labeling.