The Food and Drugs Administration (FDA) has laid down strict labeling rules to provide consumers with accurate information on cosmetic packaging and prevent the sale of unsafe products. 

Failure to comply with these rules will result in setbacks and lead to the FDA labeling your product “misbranded.” If any appropriate wordings, directions, warnings, or other required information are not displayed according to regulations, or if the labeling is false or misleading under FDA regulations, your cosmetic labeling may be deemed as misbranded.

Oversight in cosmetic labeling also means bearing the brunt of seizures and paying hefty penalties to the FDA. 

That’s why we’ve created a comprehensive guide that’ll lay out FDA cosmetic labeling requirements along with exceptions and additional requirements wherever applicable. 

Let’s get started. 

‍

Disclaimer: This blog post derives information from the U.S. Food and Drug Administration (FDA) website and is updated as of March 1st, 2024. Do refer to the FDA website for final and updated information regarding regulations. Artwork Flow is a software designed to streamline compliance for brands, not a service providing legal or regulatory advice.

‍

Legal definition of terms related to cosmetic labeling

Let’s look at the definition of a few legal terms (for clarity’s sake) before we go into FDA cosmetic labeling requirements.

1. Cosmetics

The Federal Food, Drug, and Cosmetic Act (FD&C Act) describes cosmetics as products meant to be put on or applied to the human body, like for cleansing, making someone look better, enhancing attractiveness, or changing appearance. Lotions, creams, deodorants, lipsticks, mascaras, baby care products, etc. all come under cosmetics.

When is a cosmetic also a drug?

If a product’s intended use includes preventing and treating diseases apart from enhancing appearance, it’s both a cosmetic and a drug. Such products need to meet the FDA labeling requirements for both cosmetics and drugs.

For instance, shampoo is a cosmetic. However, an anti-dandruff shampoo is both a cosmetic and a drug as it can prevent and treat dandruff, which is a form of seborrheic dermatitis (disease). The same goes for toothpaste that has fluoride, antiperspirant deodorants, and skincare and makeup that claim to protect from the sun.

2. Package

A package includes the container or wrapper in which you’ve displayed the product or delivered it to retailers. Covers of lotions, creams, and other products come under packages.

‍

3. Label

The label refers to any printed or graphic material appearing directly on the product or its attachments. 

4. Principal Display Panel (PDP)

The Principal Display Panel (PDP) is the part of a label that a consumer is most likely to see or read first, and it refers only to the front panel of the label on the outer package. 

5. Information Panel (IP)

The Information Panel (IP) refers to the back and side panels of a label. 

PS: Utilizing label management software can aid in efficiently incorporating the necessary details and ensuring compliance with FDA cosmetic labeling requirements.

‍

What are the cosmetic labeling guidelines issued by the FDA?

Most cosmetic packaging labels include an outer and inner container. Each container must be labeled appropriately to direct consumers toward important information and ensure you adhere to FDA cosmetic labeling requirements.

1. Information to be displayed on the outer container 

The package that houses the container holding the actual product is called the outer container. Boxes, wrapping papers, cartons, etc. are examples of these.

2. Information to be displayed on the inner container

The inner container holds the actual product and can be bottles, jars, etc.  

3. Ideal PDP size

4. Displaying information when the product has more than one PDP

In the case when your product has more than one PDP, you must duplicate all the required information on all the other PDPs.

5. Display information when the product contents are less

If your product weighs less than 0.25 oz, you must use a tear-away tag or affix a tape to the container to act as a PDP. 

4 things that constitute a readable label

Readable labels will inform consumers of what goes into their cosmetics and help them make an informed decision. They also help you avoid legal discrepancies and reduce chances of misbranding. 

So, we’ve included 4 things that enhance the prominence and conspicuousness of a label and make it readable.

1. Panel display

You must display the required information on panels that consumers are most likely to view at the time of purchase unless the product size is small. 

2. Panel size

Your labels must be large enough to display all the required information 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

The type size of ingredients mustn’t be less than 1/16” if your label has enough surface area. 

If the available label area is less than 1/12” (excluding raised and decorative surfaces), the type size mustn’t be less than 1/32”.

C. Net contents declaration

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

Suppose your product comes in a boudoir-type container with decorative cosmetic containers, pillboxes, compacts, pencils, and cosmetics weighing less than ¼ oz. 

In that case, you must calculate the size according to the container’s dimensions.

3. Warning statements

The type size of warning statements mustn’t be less than 1/16”. 

If the size of your package can’t accommodate the warning statement in the given height, submit a petition to the Division of Docket Management. You can then make the amendment and ask the help of the Commissioner for an alternate method. 

4. Background contrast

The label’s background mustn’t interfere with the readability of the printed matter. So, it must provide sufficient contrast and be devoid of graphical designs that obscure the printed information. 

Language requirements for cosmetic labeling

Your cosmetic labels must appear in English unless your products are distributed in a region like Puerto Rico, where English isn’t the predominant language. 

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. 

For instance, as per Canadian cosmetic labeling requirements, your labels must be presented in both English and French.

What information must appear on a cosmetic product?

According to the FDA labeling requirements for skin care products and cosmetics, cosmetic labels must include important information in a preset format to maintain uniformity and prevent misinformation.

Below is an FDA cosmetic label example.

‍

Here, on this label of Neutrogena's sunscreen, you can find every information from product identity to ‘warning’ that is stated under FDA cosmetic labeling requirements.

The following sections explain the information you must include on your cosmetic label and the format you must present it in.

1. Statement of identity

The statement of identity includes the product name and the name of the cosmetic. You may express the latter in fanciful terms or illustrative form if the nature of the cosmetic is obvious. 

For example, if your product is GlowDew body lotion, GlowDew is your product name, and body lotion is the identity of the commodity or the nature of the cosmetic. 

2. Name and place of business 

The name and place of business must include details of the manufacturer, packer, or distributor (like the firm name and the principal place of business). 

The address on the cosmetic label must contain:

• Street address
• Name of the city and state
• Zip code

If the manufacturer’s address isn’t included on the label, you must add “manufactured for…” or “distributed by…” in front of the address. 

The template for the correct address declaration is given below:

3. Net quantity of contents declaration

The net quantity of contents is the product's total weight. It must be expressed accurately on the cosmetic label using the Imperial System of Measurement. 

Weights should be expressed in avoirdupois pounds and ounces. You must prefix the weight statement with the terms “net weight” or “net wt.”

Fluid measurements must be expressed in US gallons, pints, and quarts. Prefixing terms isn’t compulsory, but you may add the terms “net contents” or “net” before the fluid measurements to improve clarity.

‍

You can also include the measurements in the Metric System along with the Imperial System. 

Here are some examples of correct net quantity declarations:

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

A. Declaration of fractions

You can either use common fractions between ½ and 1/32 or switch to decimal fractions with less than two significant numbers. 

Here are some examples of correct net quantity declarations with fractions:

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

B. Supplemental statements

You may use supplemental statements to describe the net quantity of the product on any other panel except the PDP. 

If you choose to make a declaration with a supplemental statement, you mustn’t use any term qualifying weight, measure, or count which deceives the user and exaggerates the net quantity. 

Here are a few ways to use supplemental statements without running the risk of a misbranded label:

(i). Package size

You may state representations of size (economy, large, etc.) only if the product is available in more than one size and there’s a 5% price difference between the two packages. 

(ii). Giant pint

‍You may describe the net quantity of your product using terms like a giant pint, a full quart, etc. as long as the statement isn’t deceptive. 

(iii). Number of applications

You may supplement numerical declarations of quantity with the number of applications when the product is used according to instructions. 

Here’s what a correct supplemental statement will look like:

"Net 10 fl. oz." and "Ten Applications"

‍

C. Location 

The net quantity of content declarations must appear within the bottom 30% of the label if the product is displayed in an external container and the IP of the inner container. 

4. Cosmetic warning labels

Cosmetic labels must include warning statements wherever appropriate to inform consumers of potential health hazards arising from the use of the product. 

The type of warning statements vary according to the type of cosmetic products, and we’ve included a list of them below:

A. Cosmetics with unsubstantiated safety

Every ingredient in a cosmetic must be substantiated for safety prior to marketing the product. Otherwise, the product will be considered misbranded unless it includes a warning label that states:

If an ingredient’s safety is made questionable by new information that’s inconclusive, you needn’t display a warning label on your product under the following circumstances:

• The safety of the product was determined prior to the release of new information. 
• The new information doesn’t point to health hazards in humans.
• Studies are being conducted to determine the safety of the product.

B. Cosmetic aerosols

Cosmetic aerosols refer to products that come in a self-pressurized container intended to be expelled. For example, hair sprays or other hair care products. 

Most of them are inflammable and contain components that may irritate the eyes. So, your label must include the following warning statement:

If your cosmetic product contains a propellant made of hydrocarbon or halocarbon in a self-pressurized container, you must include a second warning as given below:‍

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. Therefore, their FDA warning labels must include the following warning statement:

Caution: For external use only. Spray at least 8 inches from the skin. Do not apply to broken, irritated, or itching skin. Persistent, unusual odor or discharge may indicate conditions for which a physician should be consulted. Discontinue use immediately if rash, irritation, or discomfort develops.‍

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 tanning products must come with the following FDA warning label:

What do cosmetic claims mean?

The FDA doesn’t have a list of approved or acceptable claims for cosmetics. However, cosmetic labeling claims must be truthful and not mislead the consumer about the potency of the cosmetic or drug. 

Here are some examples of cosmetic claims and their requirements:

A. Alcohol-free

Any cosmetic that doesn’t contain ethyl alcohol can make an “alcohol-free” claim, although it might contain other alcohols like cetyl, stearate, or lanolin alcohol. 

B. Organic

The USDA regulates the term “organic”, and it refers to produce grown on soil that had no prohibited substances three years before harvest. 

So, a product that makes an “organic” claim must comply with USDA regulations and FDA labeling requirements. 

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

C. Cosmeceutical

The term “cosmeceutical” refers to products that are both drugs and cosmetics. However, this term isn’t recognized by the law. So, cosmetic product companies can’t make a “cosmeceutical” claim on their product. 

5. Cosmetic ingredient labeling requirements

The FP&L Act requires that ingredients be declared only on the label of the product containers. And it doesn’t apply to products sold at establishments and distributed for free, unless they’re also sold at retail stores. 

Typically, product ingredients are declared in descending order of predominance i.e., ingredients with the highest concentration are listed first. 

Identifying ingredients

Sticking to standardized ingredient names prevents confusion and misrepresentation.

That’s why you must express ingredient names with the name established by the Commissioner (and not go with names like “Devil Red” for your red dye).

How must ingredients be listed on cosmetic labels?

If the Commissioner hasn’t established an ingredient name, you must consider the following compendia in the order listed below:

• CTFA’s (Cosmetic, Toiletry and Fragrance Association, Inc.) Ingredient Dictionary
• United States Pharmacopeia
• National Formulary
• Food Chemical Codex
• USAN and the USP Dictionary of Drug Names

If the ingredients aren’t listed in any of the above directories, you must use a commonly known name or the technical description of the ingredient on your label. 

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 the 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.

Also Read: Ensure Total 21 CFR Compliance

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
• Assortments of similar products

Conventional and alternate cosmetic ingredient labeling

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.

Meet cosmetic labeling requirements with ease using ComplyAI

Cosmetic and skincare label requirements are stringent, and staying compliant with FDA cosmetic labeling requirements can be tricky for brands attempting to stay compliant manually.

Artwork Flow’s ComplyAI offers a flexible label compliance solution. As a cosmetic brand, you can create rulesets for different FDA regulations and run a compliance check for each ruleset. The ComplyAI feature promptly flags any errors or inconsistencies within your label, allowing you to rectify them immediately. 

For instance, for the cosmetic label of a haircare product made of a glass container, the warning statement must replace the word “puncture” with “break”. With ComplyAI, you can customize your waning ruleset by setting the restricted word as “puncture” and the preferred word as “break”. The software instantly alerts you to the presence of the restricted word or the absence of the preferred word in the label copy so you can rectify it immediately.

We hope our cosmetic labeling guide helps you achieve accurate labels consistently. With Artwork Flow's label management and compliance software, simplify FDA labeling making cosmetic labeling a breeze for your brand. Book a demo to learn more.

‍