Good Cosmetic Ingredient Dermal Penetration

Betaine Salicylate

INCI: BETAINE SALICYLATE

CAS Number
17671-53-3
Function
Antimicrobial agent, exfoliant/peeling agent
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status restricted
EU Max Conc. 2.0%
🇺🇸 US Status permitted
US Notes Salicylic acid is an OTC monograph active (anti-acne 0.5–2%). In cosmetics the betaine salt form is permitted; however, if SA function is claimed, FDA OTC drug rules apply

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
moderate
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Dermal Penetration Profile

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

Absorption %
8-12%
Penetration Level
stratum-corneum
Penetration Depth
stratum corneum/epidermis
Molecular Weight
308.3 Da
Log P
-0.5
Systemic Absorption
minimal
Topical Bioavailability
5-10%
Safety Margin Factor
moderate
Vehicle Dependent
Yes — absorption varies by formulation

Source: J Cosmet Dermatol 2019

Expert Verdict

Must declare salicylic acid equivalent concentration for EU Annex III compliance. Not to be used in products for children under 3 years (EU restriction for SA). Typical use range 1–4% betaine salicylate ≈ 0.54–2.16% SA equivalent

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Concern Level: Moderate

Frequently Asked Questions

Is Betaine Salicylate safe in cosmetics?

Must declare salicylic acid equivalent concentration for EU Annex III compliance. Not to be used in products for children under 3 years (EU restriction for SA). Typical use range 1–4% betaine salicylate ≈ 0.54–2.16% SA equivalent The EU classifies Betaine Salicylate as "restricted". Safety rating: GOOD.

Is Betaine Salicylate allowed in the EU?

Betaine Salicylate EU regulatory status: restricted. Maximum allowed concentration: 2.0%. This is based on EU Regulation 1223/2009 and its amendments.

What does Betaine Salicylate do in cosmetics?

Betaine Salicylate functions as: Antimicrobial agent, exfoliant/peeling agent. It is classified as a cosmetic ingredient in our database. CAS number: 17671-53-3.

What is the Margin of Safety for Betaine Salicylate?

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 Betaine Salicylate compliance across multiple jurisdictions:

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Ingredient Decoder
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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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