Proper labeling is an important aspect of putting your products on the market if you make and sell cosmetics. Labels catch the customers’ attention and provide important information about a product’s intended use, ingredients, the net quantity of contents, and its place of manufacture or distribution. Cosmetic labels also help consumers distinguish one brand from another, compare different products, and make informed buying decisions.
The Food and Drug Administration (FDA) regulates cosmetics sold in the US. It has laid down strict labeling rules to ensure that products provide consumers with accurate information they need to stay safe and healthy. Regardless of the size of your business, it’s your responsibility to comply with the regulations and labeling requirements outlined by the FDA.
In this article, we share useful information that can help you understand FDA cosmetics labeling requirements and how to display them on your product correctly. If you need a thorough explanation of cosmetic labeling regulations, you should see the FDA’s Cosmetic Labeling Guide, where you can find examples and answers to common questions.
Laws and Regulations That Apply to Cosmetic Products
FDA regulates cosmetic labeling under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FP&L Act). These laws and related regulations were issued to protect consumers from unsafe or deceptively labeled or packaged products and help them make informed purchasing decisions.
How do you know if your product is regulated as cosmetics and not as another product category? It depends on a product’s intended use, determined by product claims, consumer expectations, and certain ingredients.
The Federal Food, Drug, and Cosmetic Act gives a legal definition of “cosmetics.” In section 201(i) of the FD&C Act, cosmetic is defined as a product intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions.
Products marketed as cosmetics include skin creams, lotions, lipsticks, perfumes, fingernail polishes, eye and facial make-up preparations, shampoos, hair colors, permanent waves, toothpastes, and deodorants. The raw materials used as ingredients of cosmetic products are also cosmetics by law.
And what about soap—is it a cosmetic? Traditional soap products that consist primarily of an alkali salt of fatty acid are not considered cosmetics under the law if their label statements refer only to cleansing the human body. If you make cosmetic claims on the label, for example, use such words as moisturizing, deodorizing, skin softening, etc., the product is a cosmetic. Cleansing products with active ingredients that are synthetic detergents are also considered cosmetics, although they may be labeled as “soap.”
Cosmetic products are also legally considered drugs when they are intended to cleanse, beautify, or promote attractiveness, treat or prevent disease, or otherwise affect the structure or function of the human body. For example, antidandruff shampoos and anticaries toothpaste are drugs and cosmetics. Cosmetics that are also drugs must comply with both the drug and cosmetic provisions of the law.
Remember that solid shampoo bars, eco-friendly alternatives to traditional liquid shampoos, are also cosmetics. They are popular among consumers who want to reduce plastic waste in their beauty routine. Of course, not all these cosmetic products are created equal—some shampoo bars may contain SLS and other harsh chemicals that leave the scalp dry and strip hair of its natural oils. That is why it’s always important to read the ingredient list and choose well-formulated shampoo bars that are gentle for hair and safe for the environment.
Cosmetic Labeling Requirements: How to Label Cosmetics to Comply with FDA
All cosmetic products distributed in the United States must comply with the labeling regulations published by the FDA under the authority of the FD&C Act and the FP&L Act.
It’s important to note that the label statements required under the authority of the FD&C Act must appear on the inside and any outside container or wrapper. As to the FP&L Act requirements, such as, for example, ingredient labeling and statement of the net quantity of contents on the principal display panel, they only apply to the label of the outer container.
The FDA’s comprehensive cosmetic labeling guide includes detailed information about the placement of information on labels and label content, as well as prominence, type size, and ingredient lists. Here, you’ll find a summary of the FDA cosmetic labeling requirements, including some of the most important points.
All labeling information required by US law or regulation must be written in English. The exception to this rule is only for cosmetics distributed solely in a US territory where a different language is predominant, such as Puerto Rico.
So, what labeling information is required?
The principal display panel (PDP)—the part of a label that the consumer sees or examines when the product is displayed for retail sale—must include:
- An identity statement indicating the nature and use of the cosmetic product. It can be the common or usual name, a descriptive name, a fanciful name understood by the public, or an illustration.
- An accurate statement of the net quantity of contents of the product in the package in terms of weight, measure, numerical count, or a combination of numerical count and weight or measure.
The information panel (a panel other than the PDP that can accommodate label information where the consumer is likely to see it) must include:
- Name and place of business. This may be the manufacturer, packer, or distributor. The address includes the street address, city, state, and ZIP Code.
- Distributor statement. If the name and address are not those of the manufacturer, the label must clearly state it by a qualifying phrase: “Manufactured for...” or “Distributed by…”
- Material facts, such as adequate directions for safe use, if a cosmetic product could be unsafe if used incorrectly.
- Warning and caution statements for cosmetics that may be hazardous to consumers (e.g., flammable aerosols, feminine deodorant sprays, tanning products without sunscreen). The statements must be prominent and conspicuous.
- Ingredient declaration—all ingredients in a cosmetic must be declared in descending order of predominance. The ingredient declaration must be conspicuous so that it is likely to be read at the time of purchase.
As you see, cosmetic labeling requirements are stricter and more extensive than the labeling requirements applicable to soaps. Still, you must comply with them to provide consumers with accurate product information. Failure to comply with these rules will lead to the FDA labeling your product “misbranded.” Since the FD&C Act prohibits the distribution of cosmetics considered misbranded, incorrectly labeling your product can land you in a host of legal problems.