Does Your Cosmetic Contain Prohibited Ingredients?

Posted by Lisa Capote | Mar 24, 2017 | 0 Comments

If you're working to get your cosmetic on shelves, the process can seem challenging and at times, even frustrating. One way to increase your chances of success is to ensure your cosmetic does not contain ingredients prohibited by the FDA. Here's what you should know.

Cosmetics Are Not “Approved” by the FDA, and the Spirit of the Law Matters

The FDA does not have to approve cosmetics in the same way that they do prescriptions or even medical devices. For example, cosmetic manufacturers can use almost any raw ingredient, with a few exceptions, in their cosmetics under one condition. That condition is the ingredients cannot be harmful to a person when used in the manner they are intended. For example, an ingredient in mascara may not be harmful when used near the eyes, but may cause illness if ingested. This is allowed with proper warning labels.

List of Prohibited Ingredients

Although cosmetic manufacturers have a lot of leeway in what they can use in their cosmetics, there are some ingredients that are definitively prohibited from use, including:

  • Chloroform
  • Hexachloraphene
  • Mercury compounds or ingredients containing mercury
  • Bithional
  • Chloroflurocarbon propellants
  • Methylene chloride
  • Vinyl chloride
  • Sunscreens, if not used to protect product color and with proper labeling
  • Complexes containing zirconium

Cosmetics As Drugs

Some cosmetics may be subject to regulation by the FDA as a drug. If, for example, the cosmetic contains a sunscreen designed to protect the skin, the product would be subject to the same regulations as a drug. This also applies to many “acne free” cosmetics or cosmetics that contain chemicals to reduce or eliminate acne, such as salicylic acid and benzylkonium chloride.

Contact Us For Help Getting and Keeping Your Cosmetic Product on the Shelves

FDA laws and regulations are often difficult to understand and navigate, especially in the cosmetics industry. At, we can help you obtain the information you need to ensure that your cosmetic product meets the appropriate regulations for a product of its class. You'll want to be sure that you don't include any of the above listed ingredients in your cosmetic, but if you're unsure of whether or not an ingredient is or isn't approved for use by the FDA, we can assist you.

Contact us today for more information or to schedule a consultation to discuss your needs in detail. Call now at 786.871.5680.

About the Author

Lisa Capote

Ms. Capote is the founder and Managing Partner of Capote Law Firm. She founded the minority, woman owned law firm in 2006 with the goal to provide quality service to FDA regulated companies. Since that time her practice has grown to include other US federal agencies as well as an international trade component.


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