ETHYLHEXYL SALICYLATE

US FDA substance register · UNII 4X49Y0596W · registered name Octisalate · single chemical substance

Source: US FDA Unique Ingredient Identifier (UNII)

Ethylhexyl salicylate is a member of phenols and a benzoate ester. It is functionally related to a salicylic acid.

Source: PubChem

Ethylhexyl Salicylate is the ester of 2-ethylhexyl alcohol and salicylic acid. It conforms to the formula:

Allowed UV filter

United Kingdom

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

Argentina · Brazil

• Maximum concentration permitted at final product : 5%

ASEAN

• Maximum authorised concentration in the finished cosmetic product : 5%

Canada

• Maximum Concentration Permitted : ≤ 5%

Taiwan · China · South Korea

• Maximum concentration : 5%

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 to be washed away) : 10 g
• Maximum amount per 100 g (Cosmetics not used for mucosa and not to be washed away) : 10 g
• Maximum amount per 100 g (Cosmetics that may be used for mucosa) : 5.0 g

European Union

• Maximum concentration in ready for use preparation : 5%

EU Cosmetics Regulation, Annex VI (allowed UV filters), entry 20 · maximum concentration 5%

Source: EU allowed UV filters (Annex VI)

Restriction VI/20 · Other restriction: ban substances that deplete the ozone layer

Source: EU CosIng ingredient list

Reviewed by CIR: Final Report on the Safety Assessment of Salicylic Acid, Butyloctyl Salicylate, Calcium Salicylate, C12-15 Alkyl Salicylate, Capryloyl Salicylic Acid, Hexyldodecyl Salicylate, Isocetyl Salicylate, Isodecyl Salicylate, Magnesium Salicylate, MEA-Salicylate, Ethylhexyl Salicylate, Potassium Salicylate, Methyl Salicylate, Myristyl Salicylate, Sodium Salicylate, TEA-Salicylate, and Tridecyl Salicylate

Source: US Cosmetic Ingredient Review (CIR)

Reviewed by CIR: Amended Safety Assessment of Salicylic Acid and Salicylates as Used in Cosmetics

Source: US Cosmetic Ingredient Review (CIR)