Moderate Active Ingredient NOAEL Data Sensitization Data Dermal Penetration

Octocrylene

INCI: OCTOCRYLENE

CAS Number
6197-30-4
Function
Oil-soluble UVB and short-wave UVA UV filter; triplet-state quencher and radical scavenger that photostabilizes avobenzone by accepting triplet energy and dissipating it harmlessly; peak absorption ~303 nm; may hydrolyze to benzophenone as a degradation product over product shelf life
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
EU Max Conc. 10%
🇺🇸 US Status restricted
US Notes Historically marketed in the US; FDA states existing data is not sufficient to determine GRASE. Regulatory limbo. 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
moderate

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

3 study endpoints found for Octocrylene. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.

Endpoint Value Route Species Study Type Source
NOAEL 2250 ppm oral rat Subchronic COSMOS_DB
LOAEL 4500 ppm oral rat Subchronic COSMOS_DB
NOAEL 2250 ppm oral rat oral REACH

SCCS NOAEL Values

NOAEL/LOAEL values cited in official SCCS opinions for Octocrylene.

NOAEL LOAEL Route Species Study DA% (SCCS) Opinion
153 mg/kg/day 534 mg/kg/day Oral Rat Extended one-generation reproductive (EOGRTS, OECD 443) (~10 weeks premating + gestation + lactation (GLP)) 50 SCCS/1627/21 (2021)
175 mg/kg/day - Oral Rat (Wistar) Subchronic (90-day, OECD 407) (90 days (dietary)) 50 SCCS/1627/21 (2021)

Sensitization Profile

Contact sensitization data for Octocrylene based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
other
EU Allergen Listed
no
Patch Test Positive Rate
0.5%
Cross-reactivity Group
benzophenone-group
Reaction Type
photosensitivity

Source: ESSCA

Dermal Penetration Profile

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

Absorption %
5-10%
Penetration Level
stratum-corneum
Penetration Depth
stratum corneum
Molecular Weight
361.5 Da
Log P
6.9
Systemic Absorption
minimal
Topical Bioavailability
3-8%
Safety Margin Factor
moderate
Vehicle Dependent
Yes — absorption varies by formulation

Source: SCCS/1627/21

Expert Verdict

Octocrylene is a dual-function UV filter and avobenzone photostabilizer critical to many US sunscreen formulations, but it hydrolyzes to benzophenone over shelf life—a potential endocrine disruptor and suspected carcinogen that bio-accumulates in fatty tissue. Systemic absorption is confirmed; SCCS safety reassessment is ongoing through 2025–2026; FDA approval status remains in limbo pending additional safety data. Alternatives such as bemotrizinol (Tinosorb S) can stabilize avobenzone without this benzophenone degradation risk.

⚠️
Concern Level: High

Regulatory Flags

uv-filter uvb short-wave-uva oil-soluble avobenzone-stabilizer triplet-quencher fda-limbo systemic-absorption benzophenone-formation endocrine-disruption-concern photocontact-allergen fatty-tissue-accumulation sccs-reassessment-ongoing endocrine_disruptor ifra_fragrance eu_cosing_listed

Frequently Asked Questions

Is Octocrylene safe in cosmetics?

Octocrylene is a dual-function UV filter and avobenzone photostabilizer critical to many US sunscreen formulations, but it hydrolyzes to benzophenone over shelf life—a potential endocrine disruptor and suspected carcinogen that bio-accumulates in fatty tissue. Systemic absorption is confirmed; SCCS safety reassessment is ongoing through 2025–2026; FDA approval status remains in limbo pending additional safety data. Alternatives such as bemotrizinol (Tinosorb S) can stabilize avobenzone without this benzophenone degradation risk. The EU classifies Octocrylene as "permitted". Safety rating: MODERATE. 3 toxicological study endpoint(s) are available in our database.

Is Octocrylene allowed in the EU?

Octocrylene EU regulatory status: permitted. Maximum allowed concentration: 10%. This is based on EU Regulation 1223/2009 and its amendments.

What does Octocrylene do in cosmetics?

Octocrylene functions as: Oil-soluble UVB and short-wave UVA UV filter; triplet-state quencher and radical scavenger that photostabilizes avobenzone by accepting triplet energy and dissipating it harmlessly; peak absorption ~303 nm; may hydrolyze to benzophenone as a degradation product over product shelf life. It is classified as a Active Ingredient in our database. CAS number: 6197-30-4.

What is the Margin of Safety for Octocrylene?

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.

What is the NOAEL for Octocrylene?

The NOAEL (No Observed Adverse Effect Level) for Octocrylene is 2250 ppm based on a Subchronic study via oral route in rat. A total of 3 study endpoints are available. Source: COSMOS_DB.

📱

Is Octocrylene 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 Octocrylene in your formulation.