Excellent UV Filter / Sunscreen NOAEL Data SCCS/CIR Reviewed

Sulisobenzone (Benzophenone-4)

INCI: SULISOBENZONE

CAS Number
4065-45-6
Function
UV Filter
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status restricted
US Notes Not GRAS; restricted use in sunscreens

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

6 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 =1239 mg/kg/day oral rat subchronic SCCS
NOAEL 1239 mg/kg bw/day - - subchronic SCCS_PDF_extraction
NOAEL 1250 mg/kg bw/day - - - SCCS_PDF_extraction
NOAEL 1239 mg/kg bw/day oral rat subchronic SCCS_PDF_extraction
NOAEL 620 mg/kg bw/day oral - - SCCS_PDF_extraction
NOAEL 1239 mg/kg bw/day oral - subchronic SCCS_PDF_extraction

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

Expert Verdict

Well-established UV filter with excellent safety profile; permitted in EU cosmetics.

โš ๏ธ
Concern Level: Low

Regulatory Flags

eu_children_restricted ifra_fragrance

Frequently Asked Questions

Is Sulisobenzone (Benzophenone-4) safe in cosmetics?

Well-established UV filter with excellent safety profile; permitted in EU cosmetics. The EU classifies Sulisobenzone (Benzophenone-4) as "permitted". Safety rating: EXCELLENT. 6 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 Margin of Safety for Sulisobenzone (Benzophenone-4)?

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 Sulisobenzone (Benzophenone-4)?

The NOAEL (No Observed Adverse Effect Level) for Sulisobenzone (Benzophenone-4) is =1239 mg/kg/day based on a subchronic study via oral route in rat. A total of 6 study endpoints are available. Source: SCCS.

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