Cosmetic Labeling Requirements & Guidelines
To ensure consumer safety, it is crucial for cosmetic manufacturers to be meticulous in labeling their pTo protect consumer safety, cosmetic manufacturers must ensure accurate, complete, and transparent labeling. As many cosmetic products are widely accessible without prescription, clear ingredient information allows consumers to make informed choices about their makeup, skincare, and haircare products.
PRODUCT IDENTITY AND PRINCIPAL DISPLAY PANEL
Cosmetic products sold in the United States must meet FDA labeling regulations under the FD&C Act and the FP&L Act. “Labeling” includes all printed, written, or graphic material displayed on or accompanying the product. Required statements under the FD&C Act must appear on both inner and outer packaging. FP&L Act requirements—such as ingredient lists and net quantity of contents—apply only to the outer container. These requirements are codified in 21 CFR Parts 701 and 740. Products with false or misleading labeling or labels that do not meet regulatory standards are considered misbranded and may face enforcement action.
IDENTITY LABELING
The cosmetic’s identity may be presented using:
- The common or usual name
- A descriptive name
- A fanciful name (if the product’s nature is obvious)
- An illustration
The identity statement must be printed in bold type, sized proportionately to the most prominent text (typically the product name), and oriented parallel to the base of the package.
PRINCIPAL DISPLAY PANEL (PDP)
The PDP is the part of the label most visible to consumers under normal retail display conditions—typically the front of the outer package. Labels may include multiple panels, with back and side panels generally used for additional product information.
INGREDIENT LISTING AND ALLERGEN INFORMATION
Cosmetic Ingredient Labeling Rules
Cosmetic ingredient listing requirements, established in the 1970s, mandate that all ingredients—excluding fragrance, flavor, and trade‑secret ingredients—must be listed in descending order of predominance on the outer container of retail cosmetic products.
This requirement does not apply to:
- Products used solely by professionals
- Free samples not customarily sold at retail
ACCEPTABLE INGREDIENT NAMES
Ingredients must be identified using:
- FDA‑established names (21 CFR 701.30)
- Names from approved references such as:
- CTFA Cosmetic Ingredient Dictionary
- United States Pharmacopeia
- National Formulary
- Food Chemical Codex
- USAN and USP Dictionary of Drug Names
- Consumer‑recognized names
- Chemical or technical descriptions
ORDER OF INGREDIENT DECLARATION
- List in descending order of predominance.
- Exceptions include:
- Active drug ingredients
- Ingredients present at less than 1%
- Color additives
NET CONTENTS, BATCH CODE, AND EXPIRY DATE
Net Quantity of Contents
Placement Requirements:
- For products sold in an outer container, the net contents statement must appear within the bottom 30% of the PDP of the outer container and on an information panel of the inner container.
- The bottom‑placement requirement is waived for PDPs smaller than 5 square inches.
The PDP may be presented as a tag, tape, or display card panel for small or decorative containers.
Prominence Requirements:
- The declaration must be clearly separated from surrounding text by spacing equal to at least the lettering height and twice the width of the letter “N.”
Conspicuousness Requirements:
- Print must be bold, easily legible, and contrasting with the background.
- Minimum letter height must equal that of a lowercase “o.”
- Height‑to‑width ratio must not exceed 3:1.
Minimum Type Size by PDP Area:
- 1/16 inch for PDP ≤ 5 sq. in.
- 1/8 inch for PDP > 5 to 25 sq. in.
- 3/16 inch for PDP > 25 to 100 sq. in.
- 1/4 inch for PDP > 100 sq. in.
Exemptions:
- Packages under 1/4 oz. (weight) or 1/8 oz. (volume) are exempt if attached to a compliant display card or placed in a properly labeled outer container.
WARNING STATEMENTS
Under 21 CFR 740.1, cosmetic labels must include warning statements when necessary to protect consumer health. Omission of a required warning can render the product misbranded under FD&C Act Section 602(a).
Warning Statement Requirements:
Lettering must be at least 1/16 inch in height
Must be prominent and noticeable to the consumer at purchase and use
Must use bold type on a contrasting background
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