Squalene (SQUALENE)
Commonly Found In
Overview
SQUALENE is a cosmetic ingredient primarily used for EMOLLIENT and ANTIOXIDANT properties. It is a polyunsaturated triterpene with six double bonds that provides skin softening and protective benefits, though less stable than its hydrogenated form, squalane.
Also known as: Squalene, Spinacene, trans-Squalene, Supraene
Key Benefits
Squalene is naturally present in human sebum and may contribute to the skin's own lipid barrier function. Studies suggest it provides emollient properties and antioxidant activity in its native form; however, its six double bonds make it prone to oxidation, and oxidized squalene has been associated with comedogenesis and inflammatory responses in some research.
Supporting Research
- β’ Zouboulis et al. (2014) β squalene oxidation products linked to inflammatory acne pathogenesis (Dermatoendocrinol)
- β’ Kohno et al. (1995) β squalene as a natural antioxidant in human sebum (Biochim Biophys Acta)
Skin Compatibility Ratings
Comedogenic Rating
Score 2 reflects risk of oxidized squalene being comedogenic; fresh/unoxidized squalene at lower ratings. In cosmetics, squalane (hydrogenated form) is preferred for stability.
Source: Kligman & Mills comedogenicity scale; Zouboulis oxidation research
Irritancy Rating
Fresh squalene has low irritancy; oxidized squalene may trigger inflammatory responses in predisposed individuals
Source: CIR Expert Panel; cosmetic dermatology literature
Typical Use Concentration
Range
1β15%
Optimal
2β5%
Used in cosmetic formulations where non-hydrogenated form is desired. Stability concerns mean squalane is generally preferred. Some high-end formulations use squalene with antioxidant protection.
Works Well With / Avoid
Works Well With
Use With Caution
Highly susceptible to oxidation; formulations should include antioxidants (tocopherol, vitamin C) and use opaque, air-restricting packaging. Most cosmetic applications now prefer squalane (the hydrogenated, stable form).
Commonly Found In
Global Regulation Summary
Overview of current status across major international markets.
Detailed Regional Status
| Region | Status | Max Conc. | Conditions | Source |
|---|---|---|---|---|
| πͺπΊ EU | Unknown | - | - | Official β |
| πΊπΈ USA | Unknown | - | - | Official β |
| π―π΅ Japan | Unknown | - | - | Official β |
| π°π· Korea | Unknown | - | - | Official β |
| π¬π§ UK | Unknown | - | - | Official β |
π Why Regulations Differ
Squalene is permitted across all major markets without specific concentration restrictions. Both shark-derived and plant-derived sources have been used; sustainability concerns have driven a shift to plant-derived sources. No major recent regulatory changes.
Regulation Analysis
Category Comparison
There are 6 ingredients in the EMOLLIENT category.
πΏ Natural Sources
Deep-sea shark liver oil (96% content, particularly Squalidae family sharks living 600-1000m deep). Plant sources: virgin olive oil (0.8-13 g/kg or 200-7,500 mg/kg depending on cultivar and extraction), amaranth seed, rice bran, wheat germ, sugarcane. Also produced naturally in human sebum and skin.
π How It's Made
Traditionally extracted from deep-sea shark liver oil (Squalidae family). Modern sustainable production: extracted from olive oil during refining process, or produced by genetically modified yeasts and bacteria through fermentation. Genetic and metabolic manipulation significantly improved microbial production yields, offering sustainable alternative to shark harvesting.
π Uses in Cosmetics
Used to soften skin and provide moisturizing benefits. Contains six double bonds (polyunsaturated), making it prone to oxidation - less stable than hydrogenated squalane. Low acute toxicity in cosmetic concentrations, not a significant contact allergen or irritant. Most squalene is converted to squalane for cosmetic use due to stability concerns.
π¬ Other Applications
Critical pharmaceutical use as vaccine adjuvant (MF59, AS03) to boost immune response by facilitating antigen transport to immune cells. Reduces antigen amount needed, enabling faster vaccine production scaling. Used in flu, tuberculosis, malaria, HIV, schistosomiasis, herpes zoster vaccines. Pharmaceutical demand much smaller than cosmetic, but essential for vaccine manufacturing.
π‘ Fun Facts
- β’ Discovered in 1906 by Japanese researcher Mitsumaru Tsujimoto in shark liver oil - named from Latin 'squalus' meaning shark
- β’ Deep-sea sharks use squalene's low density (lighter than water) to maintain buoyancy at 600-1000m depths where they live without swim bladders
- β’ Sustainability crisis led to innovation: estimated 3 million sharks killed annually for cosmetic squalene before plant-based and biotech alternatives became viable in recent decades
Related Skin Concerns
Data Sources
- β’ CIR Expert Panel report on squalane and squalene
- β’ Zouboulis et al., Dermatoendocrinol 2014
- β’ Kohno et al., Biochim Biophys Acta 1995
- β’ EU CosIng database
Last data verification: 2026-04-12
Related Ingredients
Perhydrosqualene
SQUALANE
Ξ±-Arbutin
ALPHA-ARBUTIN
Beta-Arbutin
ARBUTIN
Nonanedioic Acid
AZELAIC ACID
CANNABIDIOL - DERIVED FROM EXTRACT OR TINCTURE OR RESIN OF CANNABIS
CANNABIDIOL - SYNTHETICALLY PRODUCED
Learn More
Frequently Asked Questions
What is SQUALENE used for in cosmetics?
SQUALENE is primarily used for emollient in cosmetic products. It also serves as skin conditioning, antioxidant. The ingredient is commonly found in moisturizers and skin softening products.
Which countries regulate SQUALENE?
SQUALENE is approved for cosmetic use in all major markets: , with no significant restrictions.
Where can I find official regulation information about SQUALENE?
Official information about SQUALENE regulations can be found on government websites: EU CosIng database, US FDA Cosmetics page, Japan MHLW cosmetics standards, UK Government cosmetics guidance, and Korea MFDS. Always verify regulatory status with these official sources before making formulation decisions.
Disclaimer
The information on this website is for educational and informational purposes only and is not intended as medical advice. While we strive for accuracy based on official government databases, cosmetic regulations change frequently. Always consult with a qualified professional or refer to the latest official regulatory documents for compliance. We are not responsible for any actions taken based on the information provided here.