Good Antioxidant Dermal Penetration

Idebenone

INCI: IDEBENONE

CAS Number

58186-27-9

Function

Synthetic antioxidant; electron carrier (SET mechanism); CoQ10 analogue with superior skin penetration; free radical scavenger; anti-aging active

Safety Rating

GOOD

Regulatory Status

🇪🇺 EU Status permitted

EU Max Conc. No specific EU concentration limit; typical cosmetic use 0.5–1%

🇺🇸 US Status permitted

US Notes Permitted as cosmetic antioxidant ingredient. Not an FDA-recognized OTC sunscreen active (not among the 16 monograph actives). Pharmaceutical idebenone (Raxone) under FDA Priority Review for Leber Hereditary Optic Neuropathy (LHON) with target action date Feb 28, 2026. CIR Final Safety Assessment (March 2022) confirmed safe for cosmetic use.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)

adequate

Dermal Absorption

low

Sensitization

low

Calculate MoS for your specific formulation with the MoS Calculator.

Dermal Penetration Profile

Skin absorption and penetration characteristics of Idebenone, relevant to systemic exposure and MoS calculations.

Absorption %

8-15%

Penetration Level

epidermis

Penetration Depth

epidermis

Molecular Weight

338.4 Da

Log P

4.2

Systemic Absorption

minimal

Topical Bioavailability

5-12%

Safety Margin Factor

moderate

Vehicle Dependent

Yes — absorption varies by formulation

Source: Arch Dermatol Res 2005

Expert Verdict

CIR Expert Panel (2022) concluded idebenone safe in cosmetics at present use concentrations. EU permitted with no Annex II or III listing. Dermal absorption approximately 2% (Norwegian FSA 2013); skin penetration limited to epidermis and stratum corneum. Rare allergic contact dermatitis cases documented but concluded safe at cosmetic use levels.

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Concern Level: Low

Regulatory Flags

contact-allergen cir-approved no-eu-restriction antioxidant low-absorption pharmaceutical-dual-use

Frequently Asked Questions

Is Idebenone safe in cosmetics?

Is Idebenone allowed in the EU?

Idebenone EU regulatory status: permitted. Maximum allowed concentration: No specific EU concentration limit; typical cosmetic use 0.5–1%. This is based on EU Regulation 1223/2009 and its amendments.

What does Idebenone do in cosmetics?

Idebenone functions as: Synthetic antioxidant; electron carrier (SET mechanism); CoQ10 analogue with superior skin penetration; free radical scavenger; anti-aging active. It is classified as a Antioxidant in our database. CAS number: 58186-27-9.

What is the Margin of Safety for Idebenone?

adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

Compliance Tools

Check Idebenone compliance across multiple jurisdictions:

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Ingredient Decoder

Paste a full ingredient list for instant analysis

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82 Allergen Checker

Check for EU declarable fragrance allergens

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Substance Compliance

Check compliance across 55 jurisdictions

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MoS Calculator

Calculate Margin of Safety using SCCS methodology

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Heavy Metal Limits

Compare limits across jurisdictions

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BHA

Good

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Good

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