Moderate Active Ingredient

Octisalate

INCI: ETHYLHEXYL SALICYLATE

CAS Number
118-60-5
Function
Oil-soluble UVB UV filter with peak absorption ~307 nm; functions as a solubilizer for avobenzone in oil-phase formulation, improving avobenzone physical stability and prolonging UVA coverage
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
EU Max Conc. 5%
🇺🇸 US Status restricted
US Notes Historically marketed in the US; FDA states existing data is not sufficient to determine GRAS. Regulatory limbo alongside seven other chemical filters. Final determination pending additional safety data.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Oil-soluble UVB filter and avobenzone solubilizer with documented systemic skin absorption; generally better tolerated than oxybenzone or octinoxate but remains in FDA regulatory limbo pending additional safety data; EU-permitted at ≤5%.

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Concern Level: Moderate

Regulatory Flags

uv-filter uvb oil-soluble fda-limbo systemic-absorption avobenzone-solubilizer photostable salicylate-class low-concern-relative-to-class ifra_fragrance eu_cosing_listed

Frequently Asked Questions

Is Octisalate safe in cosmetics?

Oil-soluble UVB filter and avobenzone solubilizer with documented systemic skin absorption; generally better tolerated than oxybenzone or octinoxate but remains in FDA regulatory limbo pending additional safety data; EU-permitted at ≤5%. The EU classifies Octisalate as "permitted". Safety rating: MODERATE.

Is Octisalate allowed in the EU?

Octisalate EU regulatory status: permitted. Maximum allowed concentration: 5%. This is based on EU Regulation 1223/2009 and its amendments.

What does Octisalate do in cosmetics?

Octisalate functions as: Oil-soluble UVB UV filter with peak absorption ~307 nm; functions as a solubilizer for avobenzone in oil-phase formulation, improving avobenzone physical stability and prolonging UVA coverage. It is classified as a Active Ingredient in our database. CAS number: 118-60-5.

What is the Margin of Safety for Octisalate?

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 Octisalate 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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