Is Oxybenzone safe in cosmetics?
Oxybenzone has a safety rating of "POOR" in our database. EU status: restricted. US status: restricted. 10 toxicological study endpoint(s) are available in our database.
Oxybenzone
Also known as: BRN 1913145, EINECS 205-031-5, NCI-C60957, NSC-7778, Oxibenzonum (+3 more)
INCI: BENZOPHENONE-3
Oxybenzone (CAS 131-57-7) is a cosmetic active ingredient functioning as Broad-spectrum UV filter; absorbs UVB and short-wave UVA radiation (290–320. NOAEL 67.9 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 6% (EU Annex VI); SCCS 2021 recommended reduction to 2.2%. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
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
Editorial assessment
POOR
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
restricted
EU Max Conc.
6% (EU Annex VI); SCCS 2021 recommended reduction to 2.2%
US 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 multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Oxybenzone.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 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 |
|---|---|---|---|---|---|
| NOAEL | 544 mg/kg bw/day | oral | mouse | Subchronic | COSMOS DB |
| NOAEL | =0.119 mg/kg bw/day | dermal | rat | dermal absorption | SCCS Opinion |
| NOAEL | =0.119 mg/kg bw/day | dermal | rat | dermal absorption | SCCS Opinion |
| NOAEL | =0.119 mg/kg bw/day | dermal | rat | dermal absorption | SCCS Opinion |
| NOAEL | =0.119 mg/kg bw/day | dermal | rat | dermal absorption | SCCS Opinion |
| NOAEL | =1.78 mg/kg bw/day | dermal | rat | dermal absorption | SCCS Opinion |
| NOAEL | =1.78 mg/kg bw/day | dermal | rat | dermal absorption | SCCS Opinion |
| NOAEL | =1.78 mg/kg bw/day | dermal | rat | dermal absorption | SCCS Opinion |
| NOAEL | =1.78 mg/kg bw/day | dermal | rat | dermal absorption | SCCS Opinion |
| NOAEL | =67.9 mg/kg bw/d | oral | - | NOAEL study | SCCS Opinion |
Pre-Calculated Safety Assessment
Conditional — safe only within SCCS limits: 6% face/hand/lip safe; 0.5% formulation protectant safe; body/sprays max 2.2% or 1.7% when combined with 0.5% protectant
Pre-calculated NOAEL → SED → MoS audit trail for Oxybenzone across SCCS product categories, with measured dermal absorption where available.
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LD50 | >16000 mg/kg | Rabbit | dermal | acute | ECHA |
| LD50 | >12800 mg/kg | Rat | oral | - | ECHA |
| LD50 | =11600 mg/kg | Rat | oral | - | ECHA |
| LD50 | >1600 mg/kg | Mouse | injection | - | ECHA |
| NOAEL | >10000 ppm | Rat | oral | short-term | ECHA |
| NOAEL | >789 mg/kg-day | Rat | oral | short-term | ECHA |
| NOAEL | =600 mg/kg-day | Rat | oral | subchronic | ECHA |
| NOAEL | =393 mg/kg-day | Rat | oral | subchronic | ECHA |
| NOAEL | =429 mg/kg-day | Rat | oral | subchronic | ECHA |
| NOAEL | =4925 mg/kg-day | Mouse | oral | subchronic | ECHA |
Sensitization AOP Dashboard
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
DPRA Cys %
4.6%
DPRA Lys %
87.4%
KeratinoSens IC50
1102 µM
hCLAT CV75
59.9 µg/mL
LLNA EC3
50%
NESIL
12500 µg/cm²
LLNA: Weak (1B)
GHS: 1B
Source: LLNA: CosmEur database; DPRA: Cosmetics Europe; KS: Cosmetics Europe; hCLAT: Cosmetics Europe
Endocrine Disruptor Evidence (Expanded)
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
Suspected
Evidence: High
(2014)
Health effects: Yes
Affected pathways: Estrogenic, Anti-androgenic, Thyroid
Regulatory framework: REACH
Source list: II
Cosmetic-Specific Mechanism
Category: UV filter
Receptor targets: ERα, ERβ, AR, TR
LOEC: 1.56 µM
EU status: restricted (max 6% rinse-off, 2% face leave-on)
agonist (ER); antagonist (AR, TR)
Dose-Response Data Points
| Endpoint | Target | Value | Direction |
|---|---|---|---|
| EC50_ER | ERα | 19.5 µM | agonist |
| IC50_AR | AR | 4.98 µM | antagonist |
| dermal_RF | skin | 0.01 mg/cm² (0.5% of applied dose) mg/cm² | - |
| dermal_RF_16h | skin | 1.0 ± 0.4 µg/cm² | - |
| Cell proliferation | ER | EC50/IC50: ~2 uM (EC50); LOEC: ~0.3 uM; NOEC: 0.1 uM mixed | agonist |
| ERE-driven luciferase induction | ERa | EC50/IC50: EC50 not determinable (partial plateau at 1 uM); LOEC: 1 uM; NOEC: 0.1 uM mixed | weak agonist |
SIN List ED: Suspected ED
Cosmetic relevance: direct
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
100 - 1,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex VI — Permitted UV Filters
Product type: a) Face products, hand products, and lip products, excluding propellant and pump spray products
b) Body products, including propellant and pump spray products
c) Other products
Max: a) 6%
b) 2,2%
c) 0,5%
Footnote 1: However, cosmetic products containing '2-Hydroxy-4-methoxy-benzophenone/Oxybenzone' and complying with the restrictions set out in Regulation (EC) No 1223/2009 as applicable on 27 July 2022 may be placed on the Union market until 28 January 2023 and be made available on the Union market until 28 July 2023.
For a) and b): Contains Benzophenone-3 (*)
Footnote (*): Not required if concentration is 0,5 % or less and when it is used only for product protection purposes.
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
KR Korea MFDS Annex 2 (Restricted)
Category: UV Filter. Max: 2.4% (face/hand/lip: 5%).
SA Saudi SFDA (VI - UV Filters)
Max: 6% Reg (EU) 2017/238 of 10 February 2017- date of application from September 2017.
JPKR Japan/Korea Cosmetics
Japan (Positive (UV Absorber)): max 5.0
Korea (Restricted): max 2.4
Japan (Restricted): max Wash-away: No limit | Leave-on: 5.0% | Mucosa: 5.0%
BRIN Brazil/India Cosmetics
India: Permitted UV Filter · max 6% Reg (EU) 2017/238 of 10 February 2017- date of application from September 2017
Additional Jurisdictional Restrictions (9)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| JP | restricted | Wash-away: No limit | Leave-on: 5.0% | Mucosa: 5.0% | Wash-away: No limit | Leave-on: 5.0% | Mucosa: 5.0% |
| CN | permitted_uv_filter | 10 | All cosmetics |
| IN | permitted_uv_filter | 10.0 | sunscreen and other cosmetic products |
| AU | restricted | - | sunscreens (therapeutic) |
| GCC | restricted | 6.0 | All cosmetics |
| UK | restricted | - | - |
| ID | permitted_uv_filter | 10% (current ASEAN-wide); Vietnam 2026 new limits: 6% facial/hand/lip; 2.2% body; 0.5% other; Indonesia reducing | - |
| ID | restricted | Reducing from 10% (exact new limit TBC; Indonesia aligning with EU) | Sunscreen products |
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (1 records across 5 sources)
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| measured_in_vitro | 8.0 | In vitro — Franz diffusion cells | - | SCCS/1223/09 (2013) (2013) |
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Sunscreen | 2–6 | 10 | CIR Safety Assessment |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Fragrance
UV stabilizer
Regulatory List Membership (4)
EU Regulated in Personal Care
IFRA Fragrance Transparency List
FDA Indirect Food Contact Additives
EU CosIng Cosmetics Ingredient Database
Editorial summary
Preliminary editorial summary for Oxybenzone — not a computed safety verdict. See the sourced toxicological data above.
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
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Oxybenzone by CAS number or substance name.
Studies
139
Lowest NOAEL
0.119
Highest NOAEL
9500
Units vary across source rows: mg/kg bw/day, mg/kg bw/d, mg/kg/ day
SCCS Opinion
ECHA
COSMOS DB
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 8.0 | In vitro — Franz diffusion cells | Sunscreen o/w / w/o emulsion |
Known Synonyms
BRN 1913145
EINECS 205-031-5
NCI-C60957
NSC-7778
Oxibenzonum
Sunscreen UV-15
Oxybenzonum
UNII-95OOS7VE0Y
Chemical Function
UV stabilizer
Fragrance
Regulatory Lists
Cleaning products and household care - shoes; Europe
drinking_water; Europe; manufacturing; plastic_additive
Europe; Personal care
Europe; Personal care
Europe; Food contact items
Europe; restricted
IFRA Transparency
Cleaning products and household care - shoes; Europe
inert_ingredient; non_food_use; Pesticides
active_ingredient; Australia
pharmaceutical
Indirect additives food contact (10/2018)
detected; Europe; Personal care - nails - nail polish
Canada; pharmaceutical
Canada; pharmaceutical
Europe; Personal care
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
OXYBENZONE
ChEMBL ID
CHEMBL1625
Max Phase
4
Adverse Event Associations
51
Frequently Asked Questions
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 NOAEL for Oxybenzone?
The NOAEL (No Observed Adverse Effect Level) for Oxybenzone is 544 mg/kg bw/day based on a Subchronic study via oral route in mouse. A total of 10 study endpoints are available. Source: COSMOS DB.
Is Oxybenzone used outside cosmetics?
Oxybenzone also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Oxybenzone compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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