Poor Active Ingredient NOAEL Data

Oxybenzone

INCI: BENZOPHENONE-3

CAS Number
131-57-7
Function
Broad-spectrum UV filter; absorbs UVB and short-wave UVA radiation (290–320 nm); one of the most widely used chemical UV filters historically in the US market
Safety Rating
POOR

Regulatory Status

🇪🇺 EU Status restricted
EU Max Conc. 6% (EU Annex VI); SCCS 2021 recommended reduction to 2.2%
🇺🇸 US Status restricted
US Notes Historically marketed in the US; FDA states existing data is not sufficient to determine GRASE. Regulatory limbo. Banned by local legislation in Hawaii (2021), Key West (2021), US Virgin Islands, Palau, Aruba, and Bonaire. Suh et al. systematic review (2020) found current evidence insufficient to establish a causal relationship between systemic oxybenzone levels and adverse human health outcomes. Final GRASE determination pending.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

7 study endpoints found for Oxybenzone. 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
LOAEL 240 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 544 mg/kg bw/day oral mouse Subchronic COSMOS_DB
LOAEL 1248 mg/kg bw/day oral mouse Subchronic COSMOS_DB
NOAEL 6250 ppm oral rat oral REACH
NOAEL 200 mg/kg bw/day dermal code:3544 dermal REACH
NOAEL 25000 ppm oral mouse oral REACH
NOAEL >10000 ppm oral rat oral REACH

Expert Verdict

The most scrutinized chemical UV filter globally and the clearest candidate for substitution in modern formulations. Bans are in force in Hawaii (2021), Key West (2021), Palau, US Virgin Islands, Aruba, and Bonaire for coral reef toxicity documented at 62 parts per trillion, causing bleaching, DNA damage, endocrine disruption of larval development, and skeletal deformities in juvenile corals. Highest systemic absorption of any UV filter in FDA PK studies, detectable in blood, urine, and breast milk after a single application. SCCS 2021 recommended halving the EU maximum to 2.2% for endocrine disruption reasons. Most common UV filter photoallergen. Regulatory trajectory is unfavorable on every axis: environmental bans expanding globally, systemic absorption concerns unresolved, endocrine-disrupting potential under active review, SCCS recommending further restriction. The strongest case for filter substitution in new product development.

⚠️
Concern Level: High

Regulatory Flags

uv-filter uvb short-wave-uva oil-soluble fda-limbo systemic-absorption highest-systemic-absorption endocrine-disruption-concern estrogenic anti-androgenic reef-toxic banned-hawaii banned-key-west banned-palau banned-us-virgin-islands banned-aruba banned-bonaire coral-bleaching dna-damage photocontact-allergen bio-accumulation breast-milk-detected sccs-2021-recommends-2pct highest-concern substitution-priority ifra_fragrance eu_cosing_listed

Frequently Asked Questions

Is Oxybenzone safe in cosmetics?

The most scrutinized chemical UV filter globally and the clearest candidate for substitution in modern formulations. Bans are in force in Hawaii (2021), Key West (2021), Palau, US Virgin Islands, Aruba, and Bonaire for coral reef toxicity documented at 62 parts per trillion, causing bleaching, DNA damage, endocrine disruption of larval development, and skeletal deformities in juvenile corals. Highest systemic absorption of any UV filter in FDA PK studies, detectable in blood, urine, and breast milk after a single application. SCCS 2021 recommended halving the EU maximum to 2.2% for endocrine disruption reasons. Most common UV filter photoallergen. Regulatory trajectory is unfavorable on every axis: environmental bans expanding globally, systemic absorption concerns unresolved, endocrine-disrupting potential under active review, SCCS recommending further restriction. The strongest case for filter substitution in new product development. The EU classifies Oxybenzone as "restricted". Safety rating: POOR. 7 toxicological study endpoint(s) are available in our database.

Is Oxybenzone allowed in the EU?

Oxybenzone EU regulatory status: restricted. Maximum allowed concentration: 6% (EU Annex VI); SCCS 2021 recommended reduction to 2.2%. This is based on EU Regulation 1223/2009 and its amendments.

What does Oxybenzone do in cosmetics?

Oxybenzone functions as: Broad-spectrum UV filter; absorbs UVB and short-wave UVA radiation (290–320 nm); one of the most widely used chemical UV filters historically in the US market. It is classified as a Active Ingredient in our database. CAS number: 131-57-7.

What is the Margin of Safety for Oxybenzone?

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 Oxybenzone?

The NOAEL (No Observed Adverse Effect Level) for Oxybenzone is 240 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 7 study endpoints are available. Source: COSMOS_DB.

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