Good Active Ingredient NOAEL Data

Avobenzone

INCI: BUTYL METHOXYDIBENZOYLMETHANE

CAS Number
70356-09-1
Function
Oil-soluble UVA1 UV filter; primary UVA absorber in US-market sunscreens; peak absorption ~357 nm; photounstable — undergoes keto-enol tautomerization and Norrish type I/II photocleavage upon UV absorption; requires co-formulation with a photostabilizer for sustained UVA protection
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. 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 at max 5% in EU (Annex VI Entry 8) and 3% in US; classified not GRAS pending additional systemic data but not considered unsafe; margin of safety >100 at maximum permitted concentrations with no genotoxicity or endocrine disruption concerns; photostability requires co-formulation with stabilizers.

⚠️
Concern Level: Low

Regulatory Flags

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

Frequently Asked Questions

Is Avobenzone safe in cosmetics?

Broad-spectrum UVA filter (340-400nm) permitted at max 5% in EU (Annex VI Entry 8) and 3% in US; classified not GRAS pending additional systemic data but not considered unsafe; margin of safety >100 at maximum permitted concentrations with no genotoxicity or endocrine disruption concerns; photostability requires co-formulation with stabilizers. The EU classifies Avobenzone as "permitted". Safety rating: GOOD. 2 toxicological study endpoint(s) are available in our database.

Is Avobenzone allowed in the EU?

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

What does Avobenzone do in cosmetics?

Avobenzone functions as: Oil-soluble UVA1 UV filter; primary UVA absorber in US-market sunscreens; peak absorption ~357 nm; photounstable — undergoes keto-enol tautomerization and Norrish type I/II photocleavage upon UV absorption; requires co-formulation with a photostabilizer for sustained UVA protection. It is classified as a Active Ingredient in our database. CAS number: 70356-09-1.

What is the Margin of Safety for Avobenzone?

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?

The NOAEL (No Observed Adverse Effect Level) for Avobenzone 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 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
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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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