Excellent UV Filter / Sunscreen NOAEL Data SCCS/CIR Reviewed

Sulisobenzone (Benzophenone-4)

Also known as: 2-Hydroxy-4-methoxy-5-sulfobenzophenone, Benzenesulfonic acid, 5-benzoyl-4-hydroxy-2-methoxy-, Benzophenone 4, 2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid, BRN 2889165 (+3 more)

INCI: SULISOBENZONE

Sulisobenzone (Benzophenone-4) (CAS 4065-45-6) is a cosmetic uv filter / sunscreen functioning as UV Filter. NOAEL 620 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted; 5 safety opinions reviewed (sccs). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.

View industrial chemical safety profile for CAS 4065-45-6 →

Auto-generated CPSR Part A draft with source citations
Function
UV Filter
Safety Rating
EXCELLENT

Chemistry & Identifiers

EC Number
223-772-2

Regulatory Status

EU EU Status permitted
US US Status restricted
US Notes Not GRAS; restricted use in sunscreens

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Sulisobenzone (Benzophenone-4).

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Sulisobenzone (Benzophenone-4). 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 =620 mg/kg bw/day oral rat repeated dose toxicity SCCS_vision_codex
NOAEL =620 mg/kg bw/day oral rat repeated dose toxicity SCCS_vision_codex
NOAEL =620 mg/kg bw/day oral rat repeated dose toxicity SCCS_vision_codex
NOAEL =620 mg/kg bw/day oral rat repeated dose toxicity SCCS_vision_codex
NOAEL =1239 mg/kg/day - rat NOAEL study SCCS_vision_codex
NOAEL =1239 mg/kg bw/day oral rat repeated dose toxicity SCCS_vision_codex
NOAEL =1239 mg/kg/day - rat NOAEL study SCCS_vision_codex
NOAEL =1239 mg/kg bw/day oral rat repeated dose toxicity SCCS_vision_codex
NOAEL =1239 mg/kg/day - rat NOAEL study SCCS_vision_codex
NOAEL =1239 mg/kg bw/day oral rat repeated dose toxicity SCCS_vision_codex

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

sccs SCCS/1660/23 27 March 2024
Verdict: safe
NOAEL: 1239 mg/kg/day (not specified)
Max Concentration: 5% in general

ed to potential endocrine disrupting properties, the SCCS is of the opinion that benzophenone-4 is safe when used as UV filter up to a maximum concentration of 5% in sunscreen, face and hand cream, all leave-on and rinse-off products (total dermal aggregate), lipstick, sunscreen propellant spray and

sccs SCCS/1660/23 27 March 2024
Verdict: safe
NOAEL: 1239 mg/kg/day (not specified)
Max Concentration: 5% in leave-on

ed to potential endocrine disrupting properties, the SCCS is of the opinion that benzophenone-4 is safe when used as UV filter up to a maximum concentration of 5% in sunscreen, face and hand cream, all leave-on and rinse-off products (total dermal aggregate), lipstick, sunscreen propellant spray and

sccs SCCS/1660/23 27 March 2024
Verdict: safe
NOAEL: 1239 mg/kg/day (not specified)
Max Concentration: 0.015% in spray/aerosol

ed to potential endocrine disrupting properties, the SCCS is of the opinion that benzophenone-4 is safe when used as UV filter up to a maximum concentration of 5% in sunscreen, face and hand cream, all leave-on and rinse-off products (total dermal aggregate), lipstick, sunscreen propellant spray and

sccs SCCS/1660/23 27 March 2024
Verdict: safe
NOAEL: 1239 mg/kg/day (not specified)
Max Concentration: 5% in spray/aerosol

ed to potential endocrine disrupting properties, the SCCS is of the opinion that benzophenone-4 is safe when used as UV filter up to a maximum concentration of 5% in sunscreen, face and hand cream, all leave-on and rinse-off products (total dermal aggregate), lipstick, sunscreen propellant spray and

sccs SCCS/1660/23 27 March 2024
Verdict: safe
NOAEL: 1239 mg/kg/day (not specified)
Max Concentration: 10% in eye area

ed to potential endocrine disrupting properties, the SCCS is of the opinion that benzophenone-4 is safe when used as UV filter up to a maximum concentration of 5% in sunscreen, face and hand cream, all leave-on and rinse-off products (total dermal aggregate), lipstick, sunscreen propellant spray and

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for Sulisobenzone (Benzophenone-4) across SCCS product categories, with measured dermal absorption where available.

EPA ToxValDB — Toxicity Values

1 toxicity value from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).

Endpoint Value Species Route Duration Source
LD50 =3530 mg/kg Rat oral - ChemIDplus

Endocrine Disruptor Evidence (Expanded)

Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.

Under investigation Evidence: Limited (2024)
Health effects: Yes
Affected pathways: Estrogenic, Thyroid
Regulatory framework: Cosmetics

Source list: II (former)

Cosmetic-Specific Mechanism
Category: UV filter
Receptor targets: ERα, ERβ, AR
LOEC: 1 µM
EU status: restricted (max 5%); SCCS/1660/23 – safe at ≤5%

agonist (ERα, ERβ); antagonist (AR)

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

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: 5%.
JPKR Japan/Korea Cosmetics
Korea (Restricted): max 5.0
Additional Jurisdictional Restrictions (2)
Jurisdiction Status Max % Product Type
CN permitted_uv_filter 5 All cosmetics
ASEAN permitted_uv_filter 5% as acid -

Expanded Dermal Absorption Data

Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.

Aggregated DA Values (5 records across 5 sources)
Type DA % Method Skin Model SCCS Ref
measured 0.8 method=measured - -
measured 5.9 method=measured - -
measured 0.145 method=measured - -
measured 6.18 method=measured - -
measured 0.05 method=measured - -

Additional Ingredient Properties

1 property record from structured ingredient metadata.

sunscreen_uv
{"cas_number": "4065-45-6", "uv_filter_type": "organic_broad_spectrum", "chemical_class": "benzophenone", "absorption_spectrum_nm_range": "280-340", "peak_absorption_wavelength_nm": "290", "molar_extinction_coefficient": "17500", "critical_wavelength_nm": "336", "UVA_PF": "3-5", "SPF_contribution_per_percent": "5.5", "photostability_rating": "photostable", "photodegradation_half_life_hours": ">10"…

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Fragrance UV stabilizer
Regulatory List Membership (2)
EU Restricted for Children (Cosmetics) IFRA Fragrance Transparency List

Expert Verdict

Expert safety assessment and concern-level summary for Sulisobenzone (Benzophenone-4).

Regulatory Flags

eu_children_restricted ifra_fragrance

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Sulisobenzone (Benzophenone-4) by CAS number or substance name.

Studies
16
Lowest NOAEL
620
Highest NOAEL
1250

Units vary across source rows: mg/kg/day, mg/kg bw/day

SCCS_vision_codex

Dermal Absorption

View details ->
Absorption % Method Vehicle
0.8 method=measured -
5.9 method=measured -
0.145 method=measured -
6.18 method=measured -
0.05 method=measured -

Known Synonyms

2-Hydroxy-4-methoxy-5-sulfobenzophenone Benzenesulfonic acid, 5-benzoyl-4-hydroxy-2-methoxy- Benzophenone 4 2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid BRN 2889165 EINECS 223-772-2 Uvinuc ms 40 UNII-1W6L629B4K

Chemical Function

UV stabilizer Fragrance

Regulatory Lists

inert_ingredient; non_food_use; Pesticides IFRA Transparency Canada; consumer_product; Substances in Products - Canada (4/2014) children; Europe; Personal care - body hygiene - body wash children; Europe; Personal care - hair styling and care - shampoo children; Europe; Personal care children; Europe; Personal care pharmaceutical Canada; pharmaceutical

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
SULISOBENZONE
ChEMBL ID
CHEMBL2059073
Max Phase
2
View full pharmaceutical profile →

Frequently Asked Questions

Is Sulisobenzone (Benzophenone-4) safe in cosmetics?

Sulisobenzone (Benzophenone-4) has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: restricted. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.

Is Sulisobenzone (Benzophenone-4) allowed in the EU?

Sulisobenzone (Benzophenone-4) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Sulisobenzone (Benzophenone-4) do in cosmetics?

Sulisobenzone (Benzophenone-4) functions as: UV Filter. It is classified as a UV Filter / Sunscreen in our database. CAS number: 4065-45-6.

What is the NOAEL for Sulisobenzone (Benzophenone-4)?

The NOAEL (No Observed Adverse Effect Level) for Sulisobenzone (Benzophenone-4) is =620 mg/kg bw/day based on a repeated dose toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS_vision_codex.

Is Sulisobenzone (Benzophenone-4) used outside cosmetics?

Sulisobenzone (Benzophenone-4) 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.

Does Sulisobenzone (Benzophenone-4) have different safety status in cosmetics vs industrial chemicals?

Sulisobenzone (Benzophenone-4) is classified GHS Danger (H315, H317, H318, H319, H335) in the chemicals database but is allowed in EU cosmetics.

Is Sulisobenzone (Benzophenone-4) in Your Products?

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