The Food and Drugs Administration (FDA) has laid down strict labeling rules to provide consumers with accurate information on products 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.”
(defined as ‘a misleading label that doesn’t state the name and place of business, isn’t conspicuous, and doesn’t meet the special packaging requirements of the Poison Prevention Packaging Act when applicable.’)
Oversight in labeling also means that you have to bear the brunt of seizures and pay 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.
Without further ado, let’s get started.
Legal definition of terms
Let’s look at the definition of a few legal terms (for clarity’s sake) before we go into FDA cosmetic labeling requirements.
A cosmetic is defined as any product that enhances appearances or cleanses the body without altering its function. Lotions, creams, deodorants, lipsticks, mascaras, baby care products, etc. all come under cosmetics.
For a more detailed explanation on the different types of cosmetics, check out the FDA’s cosmetic products and ingredients page
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.
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).
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.
Note: The immediate container is the package if the product doesn’t come in a box or carton as in deodorants and aerosols where the jars or bottles holding them are the packages.
The label refers to any printed or graphic material appearing directly on the product or its attachments.
Note: Attachments include leaflets, display packs, inserts, risers, or any other promotional material included with the product.
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.
Note: Although products have labels on their inner and outer containers, they have only one PDP on the outer package.
5. Information Panel (IP)
The Information Panel (IP) refers to the back and side panels of a label. We'll discuss all about FDA cosmetic labeling requirements like size, type, and the information that must go on a PDP and IP in the next section. Utilizing Label Design 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 products have an outer and inner container and they must be labeled appropriately to direct consumers towards important information and ensure you adhere to FDA cosmetic regulations.
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.
Note: If your product is not displayed in an outer container, the inner container becomes the outer container.
For example, The bottle holding a deodorant acts as the internal and external container as it’s not displayed with the packaging it shipped in.
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.
Your 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 the same foreign language.
The same printed matter must also appear in English to ensure ease of understanding.
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 regulations.
Declaration of information
According to FDA regulation of cosmetics and personal care products, cosmetic labels must include important information in a preset format to maintain uniformity and prevent misinformation.
The following sections explain the information you must include on your 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. And 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.
Note: The type must be in bold and sized reasonably. It must also be parallel to the base on which the product usually rests.
2. Name and place of business
The name and place of business must include details of the manufacturer, packer, or distributor (like firm name and the principal place of business).
The address on the 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 by” or “distributed by” in front of the address.
Template for correct address declaration is given below:
3. Net quantity of contents declaration
The net quantity of contents is the total weight of the product. And it must be expressed accurately 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"
Note: If your product is a kit that contains multiple items, you may use supplemental statements that state the net contents of each item.
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"
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.
Note: If the area of the PDP is less than 5 sq.in, you needn’t display the net quantity content on the inner container.
4. Cosmetic warning statements
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 which states:
Warning: The safety of this product has not been determined.
Note: 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.
Most of them are inflammable and contain components that may irritate the eyes. So, your label must include the following warning statement:
Warning: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. Keep out of reach of children.
And 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:
Warning: Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
- 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 warning labels must include the following warning statement:
Caution: For external use only. Spray at least 8 inches from 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.
Note: If the deodorant doesn’t contain propellants made of hydrocarbon, you can omit “Spray at least 8 inches from the skin.” Don’t use the words hygiene or hygienic in the warning, as it might render your product misbranded.
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 warning label:
Warning: This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn.
Note: The term tanning products refers to all topical products (gels, creams, etc.) that rely either on UV exposure or permitted color additives to tan the skin.
5. Labeling claims
The FDA doesn’t have a list of approved or acceptable claims for cosmetics. However, labeling claims must be truthful and not mislead the consumer about the potency of the cosmetic or drug.
Here are some most common labeling claims and their requirements:
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.
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.
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.
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.
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).
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 <color additive>”
4. Incidental ingredients
The FDA defines incidental ingredients as substance that are:
- Used to prepare declared ingredients.
- Added during the manufacturing process but are 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 on trade secrecy and the regulations around it, refer to the Code of Federal Regulations, Title 21
Ingredient declaration for multiple products
Your ingredient declaration in the case of multiple products must be as follows:
Packages made of similar and dissimilar products.
For example, a gift set consisting of lotion, moisturizer, and sunscreen.
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.in)
- Assortments of similar products intended for similar use
- Assortments of similar products
Conventional and alternate labeling
Here are the guidelines for conventional and alternate labeling of your cosmetics:
Labeling requirements for leaflets
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 of leaflets and padded sheets is as follows:
- They must be identical and contain the ingredient declaration for all products sold.
- You must ship them with their products and include instructions to ensure that retailers display the leaflets.
- If any person requests a copy of the ingredient declaration, the label firm must furnish them with the information.
- In case the formulation changes, you must date the new leaflets or padded sheets if they’re not shipped with the product.
Note: While using leaflets or padded sheets with the display unit, you must include the following statement in type size not less than 3/16”
"Federal law requires ingredient lists to be displayed here"
Cosmetic and skin care label requirements are stringent, and staying compliant is tough as FDA cosmetic labeling requirements aren’t clear to laypersons attempting to divine it.