Excellent Active Ingredient Dermal Penetration

Bisabolol

INCI: BISABOLOL

CAS Number
515-69-5
Function
Synthetic (nature-identical) (-)-alpha-bisabolol. Sesquiterpene alcohol; anti-inflammatory via 5-lipoxygenase and cyclooxygenase inhibition; skin-conditioning and soothing. Chemically identical to plant-derived bisabolol but produced by total synthesis (ISO 16128 NI=0 โ€” synthetic). Lacks the companion terpenoids present in plant-derived chamomile-extracted bisabolol (chamazulene, apigenin, alpha-bisabolol oxides) that may contribute synergistic anti-inflammatory effects. Pharmaceutical-grade batch consistency and purity. Penetration enhancer.
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes No FDA-specific regulation; manufacturer self-regulation applies. German chamomile (primary natural source of Bisabolol) is classified as GRAS for essential oils and extractives. CIR panel confirmed safe as used in cosmetic formulations (1999 + re-review). No FDA-imposed concentration limits; typical use 0.1-1.0%. No special listing or notification requirements under MoCRA beyond standard obligations.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
high
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Dermal Penetration Profile

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

Absorption %
8-15%
Penetration Level
stratum-corneum
Penetration Depth
stratum corneum/epidermis
Molecular Weight
222.4 Da
Log P
4.4
Systemic Absorption
minimal
Topical Bioavailability
5-12%
Safety Margin Factor
moderate
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: Int J Cosmet Sci 2011

Expert Verdict

Bisabolol (CAS 515-69-5 racemic; 23089-26-1 natural (-)-alpha-Bisabolol / levomenol) is one of the safest and most well-established cosmetic ingredients globally. CIR confirmed safe as used in cosmetic formulations (1999 original opinion plus subsequent re-review); no EU Annex II/III/V/VI restrictions apply, and no pending reclassifications exist in any major market. Typical industry use is 0.1-1.0% in leave-on formulations with no regulatory concentration limit. The critical formulation caveat is Bisabolol's penetration enhancement effect โ€” MoS calculations for co-formulated actives must account for increased dermal absorption, particularly in baby products. Natural (-)-alpha-Bisabolol (CAS 23089-26-1) is COSMOS/ECOCERT certifiable and approximately 2.24x more potent than the synthetic racemic form on an actives basis.

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Concern Level: None

Regulatory Flags

eu-unrestricted cir-approved cosmos-approved natural-origin no-sccs-opinion eu_children_restricted ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Bisabolol safe in cosmetics?

Bisabolol (CAS 515-69-5 racemic; 23089-26-1 natural (-)-alpha-Bisabolol / levomenol) is one of the safest and most well-established cosmetic ingredients globally. CIR confirmed safe as used in cosmetic formulations (1999 original opinion plus subsequent re-review); no EU Annex II/III/V/VI restrictions apply, and no pending reclassifications exist in any major market. Typical industry use is 0.1-1.0% in leave-on formulations with no regulatory concentration limit. The critical formulation caveat is Bisabolol's penetration enhancement effect โ€” MoS calculations for co-formulated actives must account for increased dermal absorption, particularly in baby products. Natural (-)-alpha-Bisabolol (CAS 23089-26-1) is COSMOS/ECOCERT certifiable and approximately 2.24x more potent than the synthetic racemic form on an actives basis. The EU classifies Bisabolol as "permitted". Safety rating: EXCELLENT.

Is Bisabolol allowed in the EU?

Bisabolol EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Bisabolol do in cosmetics?

Bisabolol functions as: Synthetic (nature-identical) (-)-alpha-bisabolol. Sesquiterpene alcohol; anti-inflammatory via 5-lipoxygenase and cyclooxygenase inhibition; skin-conditioning and soothing. Chemically identical to plant-derived bisabolol but produced by total synthesis (ISO 16128 NI=0 โ€” synthetic). Lacks the companion terpenoids present in plant-derived chamomile-extracted bisabolol (chamazulene, apigenin, alpha-bisabolol oxides) that may contribute synergistic anti-inflammatory effects. Pharmaceutical-grade batch consistency and purity. Penetration enhancer.. It is classified as a Active Ingredient in our database. CAS number: 515-69-5.

What is the Margin of Safety for Bisabolol?

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.

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