The 2026 Guide to FDA Cosmetic Labeling Requirements

1. Information on the Outer Container

The outer container is the packaging that holds the product’s primary container. This includes items like cartons, boxes, sleeves, or wrapping.

This packaging must display the required labeling information, so consumers can identify the product and access essential details before purchasing.

2. Information on the Inner Container

The inner container is the package that directly holds the cosmetic product itself, such as a bottle, jar, tube, or pump dispenser.

This container must also include required labeling information, especially if consumers may discard the outer packaging after purchasing.

3. Ideal PDP Size

4. Products With More Than One Principal Display Panel

If a product has multiple PDPs (for example, packaging designed to be displayed from different angles), all required PDP information must appear on each PDP.

5. Products With Very Small Package Sizes

If the product contains less than 0.25 oz, a tear-away tag or attached tape may be used to provide the required Principal Display Panel information when there isn’t enough space on the container itself.

Readable cosmetic labels help consumers understand what’s in the product and make informed purchasing decisions. Clear labeling also reduces the risk of legal issues and misbranding by ensuring that required information is easy to find and understand.

Below are four factors that improve the prominence and conspicuousness of a cosmetic label and make it compliant and readable.

1. Panel Placement

Required information must appear on the panels most likely to be seen by consumers at the time of purchase, unless the package is too small to accommodate all details.

This ensures critical information is visible without the consumer needing to search for it.

2. Panel Size and Type Requirements

Labels must be large enough to display all required information clearly and prominently.

A. Type size and style

The label type and size vary according to the area of the Principal Display Panel (PDP).

B. Ingredient Declaration

• If the label has a sufficient surface area, ingredient text must be no smaller than 1/16 inches in height.
• If the available labeling area is less than 1/12 inch (excluding raised or decorative surfaces), the ingredient text may be reduced, but not smaller than 1/32 inch.

C. Net Contents Declaration

The Principal Display Panel (PDP) area determines the type size of the net contents declaration.

For certain small or decorative containers, such as cosmetic compacts, pencils, pillboxes, or products weighing less than ¼ oz, the type size must be determined based on the container’s dimensions.

Under the FDA cosmetic labeling requirements, skin care and cosmetic product labels must present specific information in a standardized format. This ensures consistency across the market, helps consumers make informed decisions, and prevents misleading or incomplete product communication.

The sections below outline what information must appear on cosmetic labels and how it must be formatted.

1. Statement of Identity

The statement of identity includes:

• The brand or product name
• The nature of the cosmetic product

The nature of the cosmetic may be expressed in descriptive, fanciful, or illustrative terms, as long as the product’s purpose is clear.

Example:

If your product is called GlowDew Body Lotion:

• GlowDew = brand or product name
• Body lotion = identity of the cosmetic

Formatting requirements:

• The type must be bold and reasonably sized.
• The statement must be parallel to the base on which the package typically rests.

2. Name and Place of Business

The label must include the name and principal place of business of the manufacturer, packer, or distributor.

The business address must contain:

• Street address
• City and state
• ZIP code

If the address listed is not the manufacturer’s, it must be preceded by wording such as:

• “Manufactured for…”
• “Distributed by…”

Address Declaration Guidelines

The template for the correct address declaration is given below:

3. Net Quantity of Contents Declaration

The net quantity of contents represents the total amount of product in the package. It must be accurately stated using U.S. customary (Imperial) units. Metric units may be included in addition, but not as a replacement.

Weight Declarations

• Expressed in avoirdupois pounds and ounces.
• Must be preceded by “Net weight” or “Net wt.”

Fluid Declarations

• Expressed in U.S. gallons, quarts, pints, or fluid ounces.
• Prefixes like “Net contents” or “Net” are optional but may improve clarity.

Common Unit Abbreviations

A few examples of acceptable declarations are:

• Net wt. 3 oz.
• 3 oz. Net wt.
• Net 3 qt.
• 3 fl. oz.
• Net contents 3 fl. oz.

A. Fractional Declarations

Fractions between ½ and 1/32 may be expressed as common fractions or decimals
with no more than two significant digits.

Examples:

• Net wt. 24 oz. (1 1/2 lb.)
• 56 fl. oz. (1 qt. 1 1/2 pt.)

B. Supplemental Statements

Supplemental quantity statements may appear on panels other than the PDP.
These statements must not exaggerate or misrepresent the amount of product.

Acceptable uses include:

1. Package Size Descriptions
   Terms like economy size or large may be used only if:
   • The product is sold in more than one size.
   • There is at least a 5% price difference between sizes.
2. Descriptive Quantity Terms
   Phrases like giant pint or full quart may be used if they are not misleading.
   
   
3. Number of Applications
   You may supplement numerical declarations of quantity with the number of applications
   when the product is used according to instructions.

   Example:
   “Net 10 fl. oz.” and “Ten Applications”
   
   

4. Multi-Item Kits
   If a kit contains multiple units, you may describe both the total quantity and individual contents. For example, if your product kit has 6 facial serums with 1 fl. oz. of fluid each, your net quantity declaration will look like: Net 6 fl. oz. and 6 Bottles of 1 fl. oz. each.

C. Placement of Net Quantity Declaration

• Must appear within the bottom 30% of the PDP if the product has an outer container
• Must appear on the information panel of the inner container

Exception:
If the PDP area is less than 5 square inches, the net quantity declaration is not required on the inner container.

4. Cosmetic Warning Labels

Warning statements are required where necessary to inform consumers of potential health hazards. The required wording depends on the product type:

A. Cosmetics with Unsubstantiated Safety

All cosmetic ingredients must be substantiated for safety before marketing. Otherwise, the product is considered misbranded unless it carries this warning:

A warning is not required if:

• Safety was established before new, inconclusive data emerged.
• New data does not indicate human health risk.
• Ongoing studies are assessing safety.

B. Cosmetic Aerosols

Aerosols are products in self-pressurized containers (e.g., hairsprays) because many are flammable or irritating; they require this warning:

If the propellant contains hydrocarbon or halocarbon:

Note:

• If the product isn’t a spray, you may omit “Avoid spraying in the eyes”.
• If your product container is glass, you must replace the word “puncture” with “break”.
• Add the phrase “except under adult supervision” if it’s only intended for kids.

C. Feminine Deodorant Sprays

Federal regulation defines feminine deodorant sprays as “any deodorant spray intended to be used in the female genital area or all over the body.”

Deodorant sprays may cause irritation or itching. So, their FDA warning labels must include the following warning statement:

If the product does not use hydrocarbon propellants, you may omit “Spray at least 8 inches from the skin”. Moreover, terms like hygiene or hygienic should not be used in a way that implies medical benefit.

D. Tanning Products Without Sunscreen

Getting the perfect tan is an absolute joy, but tanning products that don’t contain sunscreen can affect your skin because of harmful UV rays from the sun. That’s why these product packaging must carry the following warning:

Cosmetic Claims: What They Mean

The FDA does not publish an approved list of cosmetic claims, but all claims must be truthful and not misleading.
Here are some examples of cosmetic claims and their requirements:

A. Alcohol-free

Permitted if the product contains no ethyl alcohol, even if other fatty or wax alcohols are present.

B. Organic

The USDA regulates the term organic, and it refers to produce grown on soil that had no prohibited substances for three years before harvesting. Products using the term must meet USDA organic standards in addition to FDA labeling rules.

For more information on the organic claim, please visit USDA’s website on organic labels.

C. Cosmeceutical

This term has no legal recognition under U.S. law. Products cannot be marketed as cosmeceuticals in a way that implies a drug-cosmetic hybrid category.

5. Cosmetic Ingredient Labeling Requirements

Under the Fair Packaging and Labeling Act, ingredients must be declared on retail product labels. These ingredients are typically listed in descending order of predominance.

Identifying Ingredients

Ingredient names must follow a standardized nomenclature. If the Commissioner has established a name, that name must be used.

If no official name exists, refer to the following sources in order:

1. CTFA Ingredient Dictionary
2. United States Pharmacopeia
3. National Formulary
4. Food Chemical Codex
5. USAN and USP Dictionary of Drug Names

If the ingredient is not listed in these, use its commonly recognized or technical name.

Order of Ingredient Declaration

Here’s the order in which you need to declare the ingredients of your cosmetic:

1. Cosmetics that are Also Drugs

If a cosmetic is also a drug, you must list the active ingredients before the cosmetic ingredients.

2. Products with Insignificant Concentration

You can list products with less than 1% concentration in any order after listing products with a concentration greater than 1% in descending order of predominance.

3. Color additives

You may list color additives in any order after declaring active ingredients (if applicable) and cosmetic ingredients. If your product has additives for color correction, you must list it on the label of each with the phrase “may contain”.

4. Incidental Ingredients

The FDA defines incidental ingredients as substances that are:

• Used to prepare declared ingredients.
• Added during the manufacturing process but removed before the cosmetic is packaged.
• Added for technical effect during manufacturing but don’t have any technical or functional impact on the finished product because of their low concentration.
• Insignificant in concentration and don’t hamper the functioning and effectiveness of the product.

5. Trade Secrets

The FDA has exempted the listing of trade secrets on the label. So, you may use the term “and other ingredients” to represent secret ingredients.
However, you must provide factual and legal grounds to the authorities before they consider your ingredients a trade secret and exempt them from the declaration.

If you’d like to learn more about trade secrecy and the regulations around it, refer to the Code of Federal Regulations, Title 21.

Cosmetic Labeling Requirements in Canada
The FDA also governs the cosmetic labeling regulations in Canada.

These rules ensure cosmetic products sold in Canada are safe, properly identified, and clearly communicated for consumer use.

Canadian cosmetic labels must include the following key elements:

• Ingredient list
• Common name of the product

• Net quantity
• Name and address of the manufacturer or distributor
• Warnings or cautions
• Directions for use

Language Requirements in Canada

Even though the cosmetic labeling elements in Canada are no different from the labeling requirements in the U.S, it is differentiated for one major reason.

Canada is a bilingual country and thus, according to Consumer Packaging and Labelling Act and Regulations (CPLA), following portions of your cosmetic labels must be listed in both English and French:

• The product’s identity
• The net quantity declaration
• The identity and place of business of the importer or manufacturer

If your label has foreign language representations, all the labeling statements must appear in that foreign language. The same information should also be presented in English for ease of understanding.

Ingredient Declaration for Multiple Products

Your ingredient declaration in the case of multiple products must be as follows:

Multi-unit Packages

Packages made of similar and dissimilar products.

For example, a gift set consisting of lotion, moisturizer, and sunscreen.

Multi-component Packages

If a package has two or more components used to make up a complete kit, it’s called a multi-component package.

For example, a hair dye kit consisting of a dye solution and hydrogen peroxide.

Multi-unit and multi-component packages must have ingredient declarations on the outer and inner containers if the latter is separated from the former during a retail sale.

Since these units have repetitive ingredients, they come with certain provisions for consolidated ingredient listing.

To understand the consolidating listing, you must be able to distinguish between 4 types of products, namely:

• Assortments of dissimilar products
• Assortments of similar products intended for similar use (area less than 12 sq. inches)
• Assortments of similar products intended for similar use

Here are the guidelines for conventional and alternate labeling for your cosmetic products:

Off-package Cosmetic Ingredient Labeling Requirements

Leaflets or padded sheets are off-package label holders that must be used only when the labeling surface area is insufficient and can’t include product information according to the regulations stated above.

The labeling requirements for leaflets and padded sheets are as follows:

1. They must be identical and contain the ingredient declaration for all products sold.
2. You must ship them with their products and include instructions to ensure that retailers display the leaflets.
3. If any person requests a copy of the ingredient declaration, the label firm must furnish them with the information.
4. In the event of a change in formulation, it is mandatory for the leaflet to acknowledge and disclose information pertaining to both formulations.

FDA Cosmetic Labeling Compliance Acts

While the FDA is the overarching legislation that has authority over cosmetics, outlining its general safety and labeling requirements, it has two acts under it to tighten the regulation strings even more.

1. Federal Packaging and Labeling Act (FPLA):

This act specifically addresses the net quantity of contents information on cosmetic packages. The goal is to streamline value comparisons and to prevent unfair packaging and labeling of consumer commodities.

It mandates specific information on labels, such as:

• Product identity
• Net quantity of contents
• Manufacturer/distributor information

2. Modernization of Cosmetics Regulation Act (MoCRA):

The MoCRA is a 2022 law that gives the FDA more control over cosmetic products. It requires cosmetic brands to register, products to list ingredients, and labels to disclose allergens.

Read more about the MoCRA labeling requirements here.

Meet Complex Cosmetic Labeling Requirements with Comply

Cosmetic and skincare labeling regulations are detailed and unforgiving. Keeping up with FDA cosmetic labeling requirements manually often leads to overlooked errors, repeated reviews, and last-minute corrections that delay launches.

An AI-powered label compliance tool, such as Comply, can simplify this process by bringing structure and automation to your cosmetic label compliance.

1. Automated FDA Checks

   With Comply, cosmetic brands can build regulation-specific rulesets aligned with FDA requirements and run automatic checks on artwork and copy. The system flags issues in real time, such as missing fragrance allergens, incorrect declarations, or mislabeling.

2. Centralized Collaboration

   Every cosmetic label involves multiple teams such as regulatory, packaging, marketing, and legal. Here, any stakeholder can review the same artwork in one place and comment directly on flagged issues.

3. Built Into Packaging Workflows

   Compliance checks don’t happen at the last minute. Teams can validate labels at multiple stages of artwork development, with a clear audit trail of changes and approvals. This helps catch problems earlier, shortens review cycles, and keeps launches on schedule.