BENZOPHENONE-3

Oxybenzone is a hydroxybenzophenone that is benzophenone which is substituted at the 2- and 4-positions of one of the benzene rings by hydroxy and methoxy groups respectively. It has a role as a xenobiotic, a dermatologic drug, a protective agent, an ultraviolet filter and an environmental contaminant. It is a hydroxybenzophenone and a monomethoxybenzene.

Source: PubChem

US FDA substance register · UNII 95OOS7VE0Y · registered name OXYBENZONE · single chemical substance

Source: US FDA Unique Ingredient Identifier (UNII)

Benzophenone-3 is a benzophenone derivative that conforms to the formula:

Allowed UV filter

United Kingdom

Source: ASEAN Cosmetic Directive · EU Cosmetics Regulation · Taiwan FDA cosmetic ingredients · UK cosmetics regulations (OPSS)

Argentina · Brazil

• Maximum concentration permitted at final product : 10%
• Other limitations and requirements : For concentrations greater than 0.5%, include a warning on the label: "contains Benzophenone-3"

ASEAN

• Maximum authorised concentration in the finished cosmetic product : 6%
• Conditions of use and warning which must be printed on the labels : Contains oxybenzone (Not required if concentration is 0.5% or less and when it is used only for product protection purposes)

Canada

• Maximum Concentration Permitted : ≤ 6%

Taiwan

• 6%

United States

• Specific Limitations and Comments : Use of the term "sunscreen" or similar sun protection wording in a product's labeling generally causes the product to be subject to regulation as a drug or a drug/cosmetic, depending on the claims. However, sunscreen ingredients may also be used in some cosmetic products to protect the products’ color. The labelling must also state why the sunscreen ingredient is used, for example, "Contains a sunscreen to protect product color." If this explanation isn’t present, the product may be subject to regulation as a drug (21 CFR 700.35). For more information on sunscreens, refer to Tanning Products

Japan

• Maximum amount per 100 g (Cosmetics not used for mucosa and not to be washed away) : 5.0 g
• Maximum amount per 100 g (Cosmetics that may be used for mucosa) : 5.0 g

China

• Maximum concentration : 10%

South Korea

• Maximum concentration : 5%

European Union

• Product Type, body parts : (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
• Maximum concentration in ready for use preparation : (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.
• Other : (a) If used at 0,5 % to protect product formulation, the levels used as UV filter must not exceed 5,5 %. (b) If used at 0,5 % to protect product formulation, the levels used as UV filter must not exceed 1,7 %.
• Wording of conditions of use and warnings : 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.

Not classified under Korea’s toxic-substance GHS list · existing chemical substance

Source: Korea toxic substances GHS register (NIER)

EU Cosmetics Regulation, Annex VI (allowed UV filters), entry 4 · maximum concentration 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. · applies to 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

Source: EU allowed UV filters (Annex VI)

Restriction VI/4 · SCCS opinion: Opinion on Benzophenone-3; OPINION on Benzophenone-3

Source: EU CosIng ingredient list

Reviewed by CIR: Annual Review of Cosmetic Ingredient Safety Assessments - 2002/2003

Source: US Cosmetic Ingredient Review (CIR)

Reviewed by CIR: Final Report: Amended Safety Assessment of Benzophenones as Used in Cosmetics

Source: US Cosmetic Ingredient Review (CIR)

Reviewed by CIR: Final Report on the Safety Assessment of Benzophenones-1, -3, -4, -5, -9, and -11

Source: US Cosmetic Ingredient Review (CIR)