The Ultimate Guide To FDA Cosmetic Labeling Requirements (Plus Your Free Checklist)

 Explore FDA cosmetic labelling regulations guide to make your labeling artwork process simpler. Stay compliant & prevent instances of misbranding with accurate cosmetic labels. Get your free checklist!


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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’s 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 labeling requirements.


1. Cosmetics

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).


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.

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. 


3. Label

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 labeling requirements like size, type, and the information that must go on a PDP and IP, in the next section. 


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. 


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.

fda cosmetic regulations


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).

Panel Size [The Ultimate Guide To FDA Cosmetic Labeling Requirements (Plus Your Free Checklist)]


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

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. 

Declaration of Information

According to FDA regulations, 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. [Read More]

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