What Is It?
Squalene and Squalane are oily substances that are common components of other oils. Both Squalene and Squalane are natural components of human sebum, a mixture of lipids produced by glands in the skin. In cosmetics and personal care products, Squalane and Squalene are used in the formulation of a wide variety of products including bath oils; hair products; eye makeup; foundations; lipstick; suntan and sunscreen products; body powders; and nail products as well as in cleansing, moisturizing, and skin care products.
Why is it used in cosmetics and personal care products?
Squalane and Squalene act as lubricating skin conditioning agents, which gives the skin a soft, smooth appearance, as well as hair conditioning agents. According to the 2020 U.S. Food and Drug Administration (FDA) Voluntary Cosmetic Registration Program (VCRP) database, Squalane and Squalene were used in 3,043 and 539 formulations, respectively. The results of concentration of use surveys conducted by the Personal Care Products Council (PCPC) in 2018 indicated, for Squalane, the maximum concentration of use was 96.8%. For Squalene, the maximum concentration of use was 1.2%.
Scientific Facts:
Squalene is found in large quantities in shark liver oil, and in smaller amounts in olive oil, wheat germ oil, rice bran oil, yeast, and in various other foodstuffs. It is the principal hydrocarbon of human surface lipids; it constitutes up to 11% of total surface fat and approximately 5% of adult skin surface sebum. In higher vertebrates and humans, it is a precursor of cholesterol. Moderate amounts are found in sites of active cholesterol synthesis, namely the liver and small intestine.
Squalane is made by completely hydrogenating shark liver oil, Squalene, or other natural oils. The hydrogenation of squalene can occur naturally in the human body. Squalane also exists as a normal constituent of human sebum. Next to Squalene, it is the most common hydrocarbon in these lipids.
Safety Information:
United States
CIR
The Cosmetic Ingredient Review
(CIR) Expert Panel first reviewed the safety of Squalene and Squalane in 1982, concluding both are safe as cosmetics ingredients in the present practices of use and concentration. In 2001, after considering new studies and updated use data on these two ingredients, the Panel determined to not re-open the safety assessment.Because it had been at least 15 years since the first re-review summary was published, in accord with CIR Procedures, the Panel considered whether the safety assessment of Squalene and Squalane should be re-opened in 2019. The Panel reviewed data that had been published since the 2001 re-review, as well as updated frequency and concentration of use data. The frequency of use of both of these ingredients had increased significantly. Clinical evidence supports the fact that these ingredients are not sensitizers; therefore, the Panel reaffirmed its original conclusion, and did not re-open this safety assessment. European Union (EU) Squalene and Squalane are listed on the EU’s Cosmetic Ingredient Inventory (CosIng) and may be used without restrictions in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European Union.
More safety Information:
CIR Safety Review: The CIR Expert Panel noted studies indicated Squalane was slowly absorbed through the skin, and both Squalene and Squalane were poorly absorbed from the gastrointestinal tract. The toxicity of these two ingredients by all routes was low. At 100% concentrations, both compounds were non-irritants to the skin and eyes. Products containing Squalene were not dermal irritants or sensitizers.
More Scientific Information:
Squalene is a branched-chain hydrocarbon with six carbon-carbon double bonds. Squalane is a saturated branched chain hydrocarbon (fully hydrogenated). Both ingredients function as skin and hair conditioning agents in cosmetics and personal care products.