What you need to know about FDA cosmetic labeling requirements

Cosmetic product labels refer to any printed or graphic element that usually appears on the packaging or inside the container itself. If you plan to distribute cosmetic products across US retail outlets, labels are crucial for marketing and instructional purposes. It’s even more important that your cosmetic product labels comply with Food and Drug Administration (FDA) requirements. More specifically, labels should follow the provisions and regulations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FP&L Act).

FDA labeling requirements ensure that consumers know how to use a product and are aware of its potential hazards. Failure to comply with FDA labeling requirements can result in seizure of cosmetic products, injunctions, hefty fines, and criminal prosecution. To make sure your business meets FDA obligations, here are the most important cosmetic labeling requirements you should follow.

What should an FDA-compliant cosmetic label include?

FDA-compliant cosmetic product labels have two main parts: principal display panels and information panels.

Principal display panels are the part of the label found on the front of the product, and are usually facing outward on store shelves for retail sale. These panels contain the product’s name, design elements, and brief product descriptions that can be quickly examined by consumers. Principal display panels must cover one side of a rectangular package or 40% of a cylindrical container.

Meanwhile, information panels are located on either the back or sides of the outer package and the inner container holding the cosmetic product. Information panels contain important details about the product, including the directions for safe use, ingredient list, warnings, and the name of the cosmetic company.

What information must be included on the principal display panel?

In order for a cosmetic product to be compliant with FDA standards, its principal display panels must include the following information:

Brand name

Brand names indicate the name of the line of cosmetic products or the company that developed them. These are often prominently displayed at the forefront of the packaging, with special graphics and fonts to make them recognizable to the everyday consumer. There are no restrictions on brand names, but the FDA prohibits companies from using ingredient names as a brand name of a product to avoid any confusion.

Identity statement

The identity statement refers to a common name or description of your cosmetic product, such as “body lotion,” “shampoo,” or “perfume.” Companies can also use fanciful names and even simple illustrations when the nature or use of the product is obvious. If you opt for a printed identity statement, use a bold font and make sure it’s a reasonable size in comparison to the brand name. Additionally, when an inner container is packed in an outer package — a bottle inside a box, for instance — only the former needs to have an identity statement. 

Net contents

Net contents indicate how much of a cosmetic product is in the package based on weight, volume, numerical count, or a combination of these measurements. Solid or semi-solid products, such as those that can’t be easily poured, should be listed by their net weight in pounds, quarts, pints, or ounces. Liquid cosmetic products must be listed by their volume expressed as net fluid ounces (fl. oz.). When dealing with aerosol cosmetic products, these can be listed by the overall weight of contents expelled. The FDA accepts reasonable margins of error for net content statements since certain product weights or volumes may vary due to evaporation or small changes in manufacturing practices.

As for where net content statements should be displayed, the FDA requires them to be printed on the bottom 30% of the panel. The font should also be at least ⅛-inch high, so they’re visible to the consumer without obstructing the product branding. Keep in mind that the font size and placement requirements don’t apply if the principal display panel is less than 5 square inches.

What information must appear on the information panel?

The FDA also has many specific requirements on what details to include in your information panels and how they should be formatted. Here are the crucial elements of an FDA-compliant information panel:  

Ingredient declaration

To notify consumers of what’s inside the cosmetic product they’re purchasing, an ingredient declaration must be prominently displayed on the information panel of a package. Cosmetic products that are also classified as drugs, like those with physiological effects, must list the drug ingredients first under “active ingredients.” Then, the remaining ingredients should be listed as “cosmetic ingredients.”

According to the FDA, ingredients must be arranged in descending order of predominance. Moisturizer ingredient declarations, for example, will list chemicals with the highest concentrations first, such as water and emulsifiers. Trace ingredients or color additives that make up less than 1% of the product are at the bottom of declarations, but they can be mentioned in any order after listing common ingredients. Any combined ingredients like alcohol-based fragrances should also be listed as separate components. If you don’t want to disclose an FDA-accepted ingredient for trade secret purposes, you can simply state “and other ingredients” at the end of the declaration.

The FDA requires ingredients to be identified by their generally recognized names. Use the following ingredient dictionaries for reference:

What’s more, font sizes of ingredient declarations must be at least 1/16 inches in height so they’re easily visible to the consumer. The only exception is if the panel surface is less than 12 square inches, in which case the font cannot be shorter than 1/32 inches.

Warning statements

Warning statements and safety instructions are absolutely crucial on cosmetic products that may be hazardous when misused. In fact, certain types of cosmetic products must feature specifically worded warning statements. Some common warning statements from the Code of Federal Regulations include:
  • Cosmetics in self-pressurized containers
    • “Warning – Avoid spraying in eyes. Contents under pressure. Do not puncture (break) or incinerate. Do not store at temperatures above 120°F. Keep out of reach of children.”
    • “Warning – Use only as directed. Intentional misuse by deliberately concentrating and inhaling the content can be harmful or fatal.”
  • Foaming detergent bath products
    • “Caution – Use only as directed. Excessive use of prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness or itching occurs. Consult your physician if irritation persists. Keep out of reach of children.”
  • Feminine deodorant sprays
    • “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.”

The FDA strongly recommends cosmetic companies to conduct comprehensive tests to prove the safety of their products. If the safety of the product is not fully substantiated, however, you must include a statement saying “Warning – The safety of this product has not been determined” on the label. 

Name and place of business

Information labels must have a small section that states your company’s name and address. However, in cases where your company didn’t directly manufacture the product, labels must state “manufactured by” or “distributed by” to credit the relevant business partners. 

The name of the business must be an officially registered corporate name. Plus, the address provided should include your main headquarters’ street address, city name, state, and ZIP code. You should also include a telephone number, so consumers can contact customer service to file product complaints or comments.  

Following all the strict FDA regulations and requirements when it comes to cosmetic product labels can be a stressful endeavor for many businesses. That’s why you should regularly check the FDA’s website for more information on cosmetic product labeling and packaging requirements. 

Pro-Motion Industries is a labeling services provider that offers various label application and container sourcing solutions. Consult with our experts today at 856-809-0040 to get started. 

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