TEA-SALICYLATE

US FDA substance register · UNII H8O4040BHD · registered name TROLAMINE SALICYLATE · single chemical substance

Source: US FDA Unique Ingredient Identifier (UNII)

TEA-Salicylate is the triethanolamine salt of salicylic acid that conforms generally to the formula:

Restricted

China · Japan · South Korea · Taiwan

Source: MFDS (Korea) cosmetic regulatory information

Argentina · Brazil

• Field of application and/or use : (a) Products without rinse. (b) Other products.
• Maximum concentration permitted at final product : (a) 2.5%
• Other limitations and requirements : a.- b.- . No use with nitrosating systems . -Pureza minimum 99% maximum -Tenor of secondary amines in raw materials 0.5%. Maximum nitrosamine -Tenor. 50 ug / kg -Envasar / keep in containers free of nitrites
• Maximum concentration permitted at final product : 0.5% (expressed as acid)
• Other limitations and requirements : Prohibited in products for children under 3 years of age, except for shampoos.
• Use conditions and warnings that must appear on the label : Products for use Adults: "Do not use in children" For products aimed at children: "Do not use in children under three years of age (except shampoo)"
• Maximum concentration permitted at final product : 12%

ASEAN

• Field of application and/or use : (a) Rinse-off hair products (b) Other products except body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant (c) Body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant
• Maximum authorised concentration in the finished cosmetic product : (a) 3.0 % (b) 2.0% (c) 0.5%
• Other limitations and requirements : (a) (b) (c) Not to be used in preparations for children under 3 years of age. Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Not to be used in oral products. For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product. These levels are inclusive of any use of salicylic acid. As a preservative, see Annex VI, Part 1, No 3
• Conditions of use and warning which must be printed on the labels : (a) (b) (c) Not to be used for children under three years of age
• Solely for products which might be used for children
• Maximum authorised concentration in the finished cosmetic product : Salicylic acid: 0,5 % (acid) Salicylic acid salts: 0,5 % (acid)
• Other limitations and requirements : Salicylic acid: Not to be used in products for children under 3 years of age. Not to be used in oral products. Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Salicylic acid salts: Not to be used in products for children under 3 years of age, except for shampoos.
• Conditions of use and warning which must be printed on the labels : Salicylic acid: Not to be used for children under 3 years of age Salicylic acid salts: Not to be used for children under 3 years of age

Canada

• Maximum Concentration Permitted : ≤ 12%

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

European Union

• Product Type, body parts : (a) Leave-on products (b) Rinse-off products
• Maximum concentration in ready for use preparation : (a) 2.5%
• Other : (a) (b) - Do not use with nitrosating systems - Minimum purity: 99% - Maximum secondary amine content: 0.5% (applies to raw materials) - Maximum nitrosamine content: 50 microgram/kg - Keep in nitrite-free containers
• Maximum concentration in ready for use preparation : Salicylic acid: 0,5 % (acid) Salicylic acid salts: 0,5 % (acid)
• Other : Not to be used in products for children under 3 years of age, except for shampoos
• Wording of conditions of use and warnings : Salicylic acid: Not to be used for children under 3 years of age **Solely for products which might be used for children under 3 years of age. Salicylic acid salts: Not to be used for children under 3 years of age ***Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.

Restriction V/3 · Other restriction: ban substances that deplete the ozone layer · SCCS opinion: Opinion concerning Salicylic Acid; OPINION ON salicylic acid (CAS 69-72-7) Submission I

Source: EU CosIng ingredient list

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

Source: US Cosmetic Ingredient Review (CIR)

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)