Lip Color

Facial Makeup Products

Facial Makeup Products are products that are used to color and highlight facial features. They can either directly add or alter color or can be applied over a foundation that serves to make the color even and smooth.

For ingredient and safety information on facial makeup products, use the links below.

Lip colors are products that apply color, texture, and/or shine to the lips using a brush or other applicator. Lip colors contain ingredients that apply color to the lips in a precise and controlled manner. Lip colors can also have multifunctional benefits, such as moisturizing, or may even include sunscreen for SPF protection.

Lip color product safety is established by selection of ingredients that are safe and suitable for this intended use and purpose. The colors themselves must be pre-approved by FDA and are listed in the color additive regulations before they may be used in cosmetics. These color additives are intended for specific use in lip products.

Additionally, some colors are also subject to the FDA certification process whereby every manufactured batch must be analyzed and found to meet required purity standards. In addition, lip colors are assessed for their potential to cause skin irritation or cause allergic reactions. Product safety is also substantiated though strict adherence to the principles of Quality Assurance and Good Manufacturing Practices (GMPs), for example, by testing the compatibility of the product with packaging as well as shelf-life stability. Companies also include contact information on their products where consumer comments or concerns may be reported. Finally, companies perform post-market monitoring of their products to track any consumer comments, questions or concerns.

Common Ingredients in Lip Products:

  • Ricinus Communis (Castor) Seed Oil
  • Glycerin
  • Propylene Glycol
  • Polybutene
  • Stearalkonium Hectorite
  • Mica
  • Titanium Dioxide
  • Zinc Oxide
  • Carbomer
  • Mineral Oil
  • Fragrance
  • Botanical Ingredients
  • Colorants
Common Ingredients: 

Lead in Lipstick

What is lead?

Lead is a bluish-gray, heavy metal that occurs naturally in the Earth’s crust and is present in trace amounts in the environment, in numerous foods and in some natural products.

Where does the lead come from?

Lead is part of the Earth and occurs at an average level of 0.0013 % (13 parts-per-million (ppm)) in the Earth’s crust. It is found in the air, water, and soil at levels that are usually below any concentration that would raise health concerns. Lead can be present in nearly all things that we use and consume on a daily basis, including food and cosmetics.

Should I be concerned about reports of lead in lipstick?

Consumers should be aware that lead is never used as an intentionally added ingredient in makeup products.  However, because lead is a naturally occurring metal, it is routinely detected in the air, water and soil.  Consequently, it may be found at extremely low levels as a trace contaminant in some raw natural ingredients that can be used to formulate products such as lipstick.

Reports about lead in lipstick are not new.  Indeed, there have been reports over the years about the presence of lead being detected in some lipsticks.  Usually, these reports allege that the levels found are at are dangerously high levels.  These reports are unfounded internet rumors without scientific merit that have been circulating for many years. 

The U.S. Food and Drug Administration (FDA) regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). These laws require that cosmetics marketed in the United States be safe under their intended and customary conditions of use, and be properly labeled.  Cosmetic regulations require pre-market approval for the color additives used as ingredients in cosmetics.  FDA has set limits for lead as an impurity in color additives as part of the requirements for the safe use of color additives.  Typically, the allowed levels are 10 to 20 parts-per-million (ppm). FDA has a regular testing program to determine compliance with these specifications.  

In December 2016, the FDA issued draft guidance, in response to the personal care product industry’s citizen petition, on the recommended maximum level of lead in cosmetic lip products (such as lipsticks, lip glosses, and lip liners) and externally applied cosmetics (such as eye shadows, blushes, shampoos, and body lotions).  The guidance supports FDA efforts to limit human exposure to lead in finished products by recommending a maximum level of 10 parts-per-million (ppm) lead as an impurity or trace contaminant in cosmetic lip products and externally applied cosmetics marketed in the United States.

The FDA determined that a maximum level of 10 ppm in such products does not pose a health risk.

Numerous in-market product surveys conducted by FDA between 2007 and 2013 indicated that levels of lead in cosmetic lip products and externally applied cosmetics are for the most part (99%) well below 10 ppm.  They concluded that a maximum level of 10 ppm for lead as an impurity in cosmetic lip products and externally applied cosmetics should be readily achievable by manufacturers that source their ingredients appropriately and use Good Manufacturing Practices (GMPs).  Furthermore, FDA felt that this guidance was consistent with lead limits set by other international regulatory bodies.  Additionally, the International Cooperation on Cosmetics Regulation (ICCR) a voluntary international group of cosmetics regulatory authorities from Brazil, Canada, the European Union, Japan and the United States that promotes regulatory convergence, has also endorsed a limit of 10 ppm lead as an impurity in cosmetics based on considerations of scientific risk assessment, Good Manufacturing Practices, technical feasibility, and appropriate analytical methods.  In addition, Health Canada has issued Guidance on lead impurities in cosmetics, also setting a limit of 10 ppm.Get more information on lead in cosmetic products.