Product Safety Essentials: Selling Cosmetic Products

Information and resources to promote safety and help you comply with applicable requirements.

This article is intended as a practical guide for sellers to address common product safety questions. Sellers are ultimately responsible for the safety and compliance of their products.

Friendly disclaimer: If you list products for sale on TuttiReal, you must comply with all federal, state, and local legal requirements and TuttiReal policies applicable to those products and product listings. This information provides an overview regarding non-exhaustive US requirements for educational purposes only, is subject to change over time, and is not legal advice. It is not intended to create, and receipt of it does not constitute, a lawyer-client relationship. The authors, TuttiReal, Inc. and TuttiReal Ireland UC disclaim all responsibility for any and all losses, damages, or causes of action that may arise or be connected with the use of or reliance on these materials. Requirements may vary depending on your location and where you make your products available. TuttiReal reserves the right to remove listings of products that do not comply or that may be unsafe for any other reason.

Is my product considered a cosmetic?

US law defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.” The definition covers makeup, creams, lotions, cleansing products, shampoo, conditioner, hair color, perfume, and more. If your product meets this definition, your product is considered a cosmetic under the law.

If your product meets this definition, your product is considered a cosmetic under the law—even if you categorize it as a “personal care,” “beauty,” or other type of product. In the US, cosmetics are regulated by the Food and Drug Administration (FDA), and some of the main regulatory requirements for cosmetics are discussed below. It’s your responsibility as an TuttiReal seller to make sure that your cosmetic products are safe and comply with all applicable requirements. 

What labels do I need to have on the cosmetics products I sell?

The US federal laws that cover cosmetics labeling are the Food, Drug, and Cosmetic Act, and the Fair Packaging and Labeling Act, which include extensive requirements for labeling cosmetics. Cosmetics that are not labeled correctly are considered “misbranded” and are illegal to sell. There may be additional state laws that apply to your products. Labels may not be false or misleading, and must include required information. Some of the main information required for cosmetics labeling include:

• Ingredient lists
• Identity/description of the product
• The name and contact information of the manufacturer, packager, or distributor
• Net contents
• Country of origin
• Any required warnings (see additional information below)
• Active ingredients for cosmetics that are also drugs (see additional information below)

The laws and regulations on labeling include requirements of where the information needs to be placed on the label, prominence, and more. For more guidance on labeling requirements please see FDA’s labeling guidance here. We reserve the right to request copies of your labels or ensure that label information is part of your listing. We also reserve the right to remove listings that may violate any legal requirement, including labeling. 

Are there any warnings or instructions I need to include on the labels?

Depending on the product, specific warnings may be required. If your product is on the list below, the FDA requires certain warnings:

• Cosmetics with unsubstantiated safety, meaning cosmetics where there is not enough information regarding the ingredients and/or finished product to substantiate their safety
• Cosmetics in aerosol containers
• Cosmetics in aerosol containers that use halocarbon or hydrocarbon as a propellant
• Feminine deodorant sprays
• Foaming detergent bath products
• Tanning products that do not contain sunscreen
• Hair dye using coal-tar (petroleum derived) colors

For more information on required warnings, please see FDA’s regulations here and FDA’s labeling guidance here. We also reserve the right to remove listings that may violate any legal requirement, including warnings, and to request any additional information necessary for us to assess compliance with our policies and with applicable requirements.

What coloring materials can I use in my cosmetics?

In the US, all cosmetics, with a narrow exception for certain specific types of hair dyes, can only contain color additives that are approved by the FDA. Some color additives can only be used if they are from a batch that was certified by the FDA. Cosmetics that are used near the eye (anywhere from the eyebrow to below the lower lashes), lipstick, and other cosmetics used on mucous membranes (e.g., lips, nose), can only contain color ingredients if the regulation for that additive specifically permits such use.

If you are formulating your own cosmetics, you must make sure you are only using colors from the approved list. If you are sourcing cosmetics produced by others, you must make sure they are only using approved color additives. You must also make sure that colors are listed on the ingredient list as required by FDA regulations.

For more information on color additives in cosmetics, please see the FDA’s fact sheet here, and table of approved colors here. We also reserve the right to remove listings that may violate any legal requirement, including use of unapproved color additives, and to request any additional information necessary for us to assess compliance with our policies and with applicable requirements.

Are the cosmetics I sell also considered to be drugs?

Sometimes, because of their intended use or function, products can be both a cosmetic and a drug under US law. This occurs when a cosmetics product is also intended to cure, mitigate, treat, prevent, or diagnose a disease, or affect the structure or function of the body, which is the FDA’s definition of a “drug.” Products that often fall into both categories include fluoride toothpaste (while toothpaste is meant for cleansing purposes, the addition of fluoride to prevent tooth decay puts it in the drug category), anti-dandruff shampoo (meant to treat or prevent dandruff but also to cleanse hair), and sunscreen moisturizers (meant to prevent cancer and other sun-related skin damage and also to moisturize skin).

Please note that the FDA does not separately recognize the category of “cosmeceutical.” If a product is both a cosmetic and a drug, it would be prohibited by our Prohibited Items policy for drugs. For more information please see the FDA’s guidance here. Additionally, TuttiReal maintains strict policies against the selling of medical devices, drugs, and items with prohibited medical claims. We reserve the right to request documentation to assess compliance with our policies and applicable requirements, and to remove listings of non-compliant products.

Are there any products or ingredients that I may not use in my cosmetics?

As noted above, color additives that are not approved for use in cosmetics or the type of cosmetics being sold, are also prohibited. The FDA also has a list of additional ingredients that are either prohibited or restricted, which you can find here. Many states have also passed laws restricting certain chemicals in cosmetics and their packaging or requiring reporting of the use of such chemicals to the state. It’s your responsibility to know what ingredients are used in the products you sell, and to make sure they are permitted for use in these products. We reserve the right to request information regarding the ingredients in the products you sell and to remove listings that may contain banned, restricted, or potentially unsafe ingredients.

Are there any additional requirements for essential oils?

It is your responsibility to understand the requirements that apply to the essential oils you sell. Regulators such as the FDA and Consumer Product Safety Commission have established limitations and requirements for certain essential oil products. For example, essential oils that are used as massage oil to lubricate the skin or as a fragrance are cosmetics. Claims that the essential oils will cure or alleviate an illness or health condition are medical claims and can make your product subject to FDA regulations for drugs and subject to removal from TuttiReal per our policies. Additionally, if your essential oils contain methyl salicylate (which is common in wintergreen and birch essential oils), it must be packaged in child resistant packaging that complies with Consumer Product Safety Commission regulations. These examples are not intended to be exhaustive, and we urge you to consult a qualified expert to determine which requirements apply to your products.

Are there other tips for making sure the cosmetics I sell are safe?

It’s your responsibility to make sure that your cosmetics are safe. This means using approved color additives, avoiding banned or restricted ingredients, maintaining adequate substantiation for safety, and complying with labeling and warning requirements. It also means making sure your products are made, packaged, stored, and shipped in a way that will make sure they do not get contaminated by harmful microorganisms like fungi or bacteria, or by unsafe chemicals. You or your supplier should use Good Manufacturing Practices (GMP) to make sure that your cosmetics are made in a safe and clean environment. Buying all ingredients and supplies from trusted sources can ensure that you know exactly what goes into your products.

Cosmetics should be packaged in a way that will keep dirt and germs out, and stored or shipped in a way that will not cause them to spoil or get contaminated. If you become aware of potential safety or compliance issues relating to your products, you must immediately notify TuttiReal and the FDA, and take action to withdraw or recall the product as necessary. Please see additional FDA guidance for Small Businesses & Homemade Cosmetics here. FDA’s guidance to industry on recalls is available here.