Moderate Emollient Dermal Penetration

Lanolin

INCI: LANOLIN

CAS Number
8006-54-0
Function
Complex mixture of esters, diesters, and hydroxy esters derived from sheep wool wax. Highly effective occlusive emollient mimicking skin sebum lipid complexity. Modern ultra-refined pharmaceutical grades achieve allergen levels below detectable thresholds. Functions as emollient, occlusive, and skin-conditioning agent.
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes FDA-approved OTC active ingredient: skin protectant at 12.5-50% (21 CFR 347.10(k)); anorectal products (21 CFR 346.14); ophthalmic products (21 CFR 349.14). Inactive ingredient: ophthalmic ointments up to 10% (Lanolin Alcohol), topical creams/lotions/ointments up to 6% (Lanolin Alcohol). Permitted food additive in chewing gum base (21 CFR 172.615). CIR 2024: safe as used.

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
high
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

Dermal Penetration Profile

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

Absorption %
2-6%
Penetration Level
stratum-corneum
Penetration Depth
stratum corneum
Molecular Weight
Variable Da
Log P
n/a
Systemic Absorption
minimal
Topical Bioavailability
1-4%
Safety Margin Factor
low
Vehicle Dependent
Yes — absorption varies by formulation

Source: CIR

Expert Verdict

Lanolin is assessed safe by CIR 2024 at present concentrations and EU unrestricted, but was named 2023 ACDS Allergen of the Year with sensitization rates of 3.3-4.63% in dermatitis patients; use caution in products targeting compromised skin populations and prefer medical-grade or HPA-grade lanolin to minimize sensitization potential.

⚠️
Concern Level: Moderate

Regulatory Flags

eu-unrestricted cir-approved no-sccs-opinion animal-derived allergen sensitizer eu_children_restricted fda_food_additive

Frequently Asked Questions

Is Lanolin safe in cosmetics?

Lanolin is assessed safe by CIR 2024 at present concentrations and EU unrestricted, but was named 2023 ACDS Allergen of the Year with sensitization rates of 3.3-4.63% in dermatitis patients; use caution in products targeting compromised skin populations and prefer medical-grade or HPA-grade lanolin to minimize sensitization potential. The EU classifies Lanolin as "permitted". Safety rating: MODERATE.

Is Lanolin allowed in the EU?

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

What does Lanolin do in cosmetics?

Lanolin functions as: Complex mixture of esters, diesters, and hydroxy esters derived from sheep wool wax. Highly effective occlusive emollient mimicking skin sebum lipid complexity. Modern ultra-refined pharmaceutical grades achieve allergen levels below detectable thresholds. Functions as emollient, occlusive, and skin-conditioning agent.. It is classified as a Emollient in our database. CAS number: 8006-54-0.

What is the Margin of Safety for Lanolin?

not established 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 Lanolin compliance across multiple jurisdictions:

🔬
Ingredient Decoder
Paste a full ingredient list for instant analysis
 🌸
82 Allergen Checker
Check for EU declarable fragrance allergens
 🧪
Substance Compliance
Check compliance across 55 jurisdictions
 🧮
MoS Calculator
Calculate Margin of Safety using SCCS methodology
 ⚗️
Heavy Metal Limits
Compare limits across jurisdictions

Related Ingredients

Triethylhexanoin
Excellent
Borago Officinalis Seed Oil
Excellent
Microcrystalline Wax
Excellent
Dilinoleic Acid
Good
Kukui Nut Oil (Aleurites Moluccanus)
Good
Browse all 30,000+ ingredients →
📱

Is Lanolin in Your Products?

Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free →

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Lanolin in your formulation.

Ingredient Decoder MoS Calculator