Good Antioxidant NOAEL Data

AVOBENZONE (BUTYL METHOXYDIBENZOYLMETHANE)

INCI: AVOBENZONE

CAS Number
70356-09-1
Function
Broad-spectrum UVA filter (340-400nm)
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status permitted
EU Max Conc. 5%
🇺🇸 US Status restricted
US Notes FDA OTC monograph active ingredient. Max concentration 3% in US. Classified not GRAS per September 27, 2021 proposed administrative order (86 FR 53546) due to systemic absorption exceeding 0.5 ng/mL threshold. FDA stated this does NOT mean the ingredient is unsafe — products remain on market and recommended for continued use. Additional nonclinical toxicology data (carcinogenicity, reproductive) required by FDA.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

2 study endpoints found for AVOBENZONE (BUTYL METHOXYDIBENZOYLMETHANE). 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 450 mg/kg bw/day oral rat oral REACH
NOAEL 360 mg/kg bw/day dermal code:3484 dermal REACH

Expert Verdict

Broad-spectrum UVA filter (340-400nm) permitted in EU at max 5% (Annex VI Entry 8). US FDA max 3%, classified not GRAS pending additional systemic toxicology data but not considered unsafe. MoS >100. No genotoxicity or endocrine disruption concerns.

⚠️
Concern Level: Moderate

Regulatory Flags

systemic-absorption fda-not-grase photostability-concern photoallergy-risk uva-filter annex-vi ifra_fragrance eu_cosing_listed

Frequently Asked Questions

Is AVOBENZONE (BUTYL METHOXYDIBENZOYLMETHANE) safe in cosmetics?

Broad-spectrum UVA filter (340-400nm) permitted in EU at max 5% (Annex VI Entry 8). US FDA max 3%, classified not GRAS pending additional systemic toxicology data but not considered unsafe. MoS >100. No genotoxicity or endocrine disruption concerns. The EU classifies AVOBENZONE (BUTYL METHOXYDIBENZOYLMETHANE) as "permitted". Safety rating: GOOD. 2 toxicological study endpoint(s) are available in our database.

Is AVOBENZONE (BUTYL METHOXYDIBENZOYLMETHANE) allowed in the EU?

AVOBENZONE (BUTYL METHOXYDIBENZOYLMETHANE) EU regulatory status: permitted. Maximum allowed concentration: 5%. This is based on EU Regulation 1223/2009 and its amendments.

What does AVOBENZONE (BUTYL METHOXYDIBENZOYLMETHANE) do in cosmetics?

AVOBENZONE (BUTYL METHOXYDIBENZOYLMETHANE) functions as: Broad-spectrum UVA filter (340-400nm). It is classified as a Antioxidant in our database. CAS number: 70356-09-1.

What is the Margin of Safety for AVOBENZONE (BUTYL METHOXYDIBENZOYLMETHANE)?

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.

What is the NOAEL for AVOBENZONE (BUTYL METHOXYDIBENZOYLMETHANE)?

The NOAEL (No Observed Adverse Effect Level) for AVOBENZONE (BUTYL METHOXYDIBENZOYLMETHANE) is 450 mg/kg bw/day based on a oral study via oral route in rat. A total of 2 study endpoints are available. Source: REACH.

Compliance Tools

Check AVOBENZONE (BUTYL METHOXYDIBENZOYLMETHANE) compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
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Substance Compliance
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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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