FDA Cosmetic Labeling Requirements: Everything You Need to Know

When it comes to cosmetic labeling, it takes time to design a label that meets all legal requirements, no matter what your packaging looks like.

To make the situation even more frustrating, labeling requirements for cosmetics are unusually confusing. It’s not always clear what is and isn’t a cosmetic, and a misbranded product can cause serious delays for your place of business, ultimately affecting when your products hit the market. Not only that, but regulatory information can be difficult to understand.

Here’s what you need to know to ensure you’re meeting the Federal Food and Drug Administration’s (FDA) cosmetic labeling requirements while giving consumers the information needed to make informed decisions.

When You Need to Follow This Cosmetic Labeling Guide

The Federal Food, Drug and Cosmetic Act (FD&C Act) establishes the definition of what is a cosmetic and/or drug. A lot of the time, products will fall under both categories.

Cosmetic products are defined by their intended use. If it is going to be rubbed, poured, sprinkled, sprayed or applied to the human body to clean it, make it more attractive, or alter its appearance, then it is considered cosmetic.

Drugs, on the other hand, are used to diagnose, cure, treat, or prevent disease – or, affect the structure or function of the body.

If your product has two intended uses it can be both a drug and a cosmetic. For instance, feminine deodorants that also have antiperspirants along with a floral smell are both a cosmetic product and a drug – meaning you have to follow the regulations for both.

Drug ingredients include moisturizing agents like petrolatum. Creams containing these ingredients must follow the FDA’s drug labeling regulations as well as any required information for cosmetics not covered therein. The same goes for moisturizing creams that claim they will regenerate cells or any such products that claim they can affect the structure of the body.

Soaps whose sole cleaning agent is alkali salts of fatty acids are not considered a cosmetic. These fall under the jurisdiction of the Consumer Product Safety Commission. However, if any scent is added, it’s cosmetic.

No matter what you’re making, any organic product claims are regulated by the USDA’s National Organic Program (NOP).

If you’re still not sure if your product labeling needs to follow cosmetic regulations, the FDA has an in-depth guide on product categories.

Key Cosmetic Labeling Regulations

FDA labeling requirements are covered in the FD&C Act and the Fair Packaging and Labeling Act (FPLA). While there is some flexibility in label design, there are four principles guiding cosmetic manufacturing practices in the code of federal regulations:

• The product cannot contain any restricted ingredients.

• All color additives must be approved by the FDA. In some cases, these dyes must be tested by the FDA before they can be used in cosmetics.
• The product cannot cause harm if used as directed. If it can cause harm through misuse, warnings must be included that instruct users on how to avoid harm.
• The product must not be adulterated or misbranded in any way.

What Information Is Required By FDA Cosmetic Labeling Requirements?

All of the label information listed must appear on the outer container. All required information must be stated in English. This information is split between the principal display panel (PDP) and the information panel.

The PDP is the part of the label that faces the consumer when it’s on the shelf. It must cover the entire side of a rectangular container or 40% of a cylindrical container. This panel includes the following information:

Brand Name

Ingredients cannot be used as part of this name.

Net Quantity of Contents

Liquids are measured in volume, while solids and semi-solids are measured by net weight. Numerical counts of net weight must be stated in both customary and metric units, while liquids are expressed in terms of U.S. gallons, quarts, pints or fluid ounces.

This measurement must account for fluctuations in packaging and evaporation during storage, so it’s the same or less than the amount of product that reaches the consumer. The quantity must be printed on the bottom 30% of the PDP.

Identity Statement

This is the common name for the product, such as “shower gel” or “eyeliner.” If you use outer and inner containers, only the inner container needs an identity statement.

By comparison, the information display panel goes to the right of the principal display panel. If there isn’t enough space, this panel can go on the back of the container. It includes the following pieces of information:

Safe Use Directions

Safe use directions need to be displayed in a noticeable, prominent way.

Declaration of Ingredients (in order of predominance)

Ingredient declaration must be stated in order of weight from highest to lowest under their industry standard names. Ingredients that make up less than 1% of the product can be listed in any order. Color additives must be at the end of the ingredient list. According to ingredient labeling regulations, any ingredients that are a trade secret can be listed as “other ingredients.”

International Nomenclature Cosmetic Ingredient (INCI) names are preferred for ingredient names. If your product has ingredients not included in the INCI, you can use names from the United States Pharmacopeia (USP) dictionary, the Food Chemical Codex, the American Medical Association’s United States Adopted Names (USAN), or the National Formulary.

Warnings

Warning-related information must be prominent on the label. While FDA regulations don’t clearly define “prominent,” best practices include the use of bold text for “Warning” along with large print for the notice.

Business Information

Business information includes the manufacturer, distributor or packager of the product. The name as well as the business’s street address must be included. If the company listed isn’t the manufacturer, the statement “distributed by” or “manufactured for” must be included. If the product is imported, there must be a country of origin statement.

Best by dates and lot numbers aren’t included in labeling requirements for cosmetics, but they are allowed where needed. These ensure consumers are using fresh products, and help with issuing recalls and identifying production problems. Our print and apply labelers make it easy to add this information to each container.

Common Required Warnings for the Labeling of Cosmetics

While the warnings needed to meet FDA labeling requirements vary from product to product, there are a few warning statements that cosmetic manufacturers need to regularly use.

Adult products should include the statement “Keep Out of Reach of Children.” Products for children should include the statement “Keep Out of Reach of Children Except Under Adult Supervision.”

Cosmetic aerosols under pressure must include this warning: “Warning – Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at a temperature above 120°F. Keep out of reach of children.” For glass containers, replace “puncture” with “break.” Products that don’t spray, like shaving cream, don’t need the phrase “Avoid spraying in eyes.”

Any product with 10% or more propellant that is over 0.5 ounces in size must include this warning:  “Warning — Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.”

Tanning products that don’t contain sunscreen must use this warning: “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.

If there isn’t conclusive evidence that the product and all of its ingredients are generally considered safe, it needs this warning: “Warning: The safety of this product has not been determined.”

No Matter What You’re Labeling, We Have Equipment that Fits Your Products

CTM Labeling Systems manufactures pressure sensitive labeling equipment for a wide range of containers and applications (including everything from semi-automatic vial labelers for travel-size products to our Top Bottom Split Conveyor System for high-speed box labeling).

If you’re looking for a better labeling system, contact us today. Our local distributors will work with you to find the perfect solution for your products.