Dermoessential sun mist spray

Active ingredient

Active Ingredient: Ethylhexyl Methoxycinnamate 7.0%, Ethylhexyl Salicylate 5.0%, Homosalate 5.0%, Octocrylene 3.0%

Inactive ingredient

Inactive Ingredients: Water, Alcohol, Butylene Glycol, Bis-EthylhexyloxyphenolMethoxyphenyl Triazine, Isononyl Isononanoate, Phenethyl Benzoate, Glycerin, Portulaca Oleracea Extract, Ethylhexyl Methoxycrylene, Sorbitan Stearate, Polysorbate 60, PEG-100 Stearate, Glyceryl Stearate, Fragrance, Ethyl Hexanediol, Panthenol, Tocopheryl Acetate, Allantoin, Glyceryl Caprylate, Disodium EDTA, Glycyrrhiza Glabra (Licorice)Root Extract, Centella Asiatica Extract, Malpighia Emarginata(Acerola) Fruit Extract, Vitis Vinifera (Grape) FruitExtract, Propylene Glycol, Morus Alba Root Extract, Ascorbyl Tetraisopalmitate, Anthemis Nobilis FlowerExtract, Lecithin, Squalane, Ubiquinone, Polysorbate 80, Phenoxyethanol

Purpose

Purpose: Sunscreen

Warnings

Warnings: 1. If the following side effects occur, immediately discontinue use. Before resuming use, consult a dermatologist as continual use may worsen symptoms. A) If red spots, swelling, itching, irritation, or other discomforts occur after using the product. B) If the above symptoms occur on the applied area after exposure to direct sunlight. 2. Do not use on open wounds or on areas of skin exhibiting signs of eczema or dermatitis. 3. Storage and handling precautions A) Keep product out of reach of infants and children. B) Ensure that lid is closed after use. C) Do not store in places subject to high or cold temperatures or under exposure to direct sunlight. D) Use care to avoid eye contact when using this product.

Description

Indications & usage: Before using sun mist, shake enough it then spray evenly to areas exposed to sunlight such as the face, neck, arms, legs.

Dosage & Administration: Spread appropriate amount to areas.

Ingredients and appearance - Product information

Dermoessential sun mist spray- Octinoxate, octisalate, homosalate, octocrylene

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 70265-090
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Octinoxate ( UNII: 4Y5P7MUD51)( Octinoxate - UNII: 4Y5P7MUD51 ) 4.9 gin 70 mL
Octisalate ( UNII: 4X49Y0596W)( Octisalate - UNII: 4X49Y0596W ) 3.5 gin 70 mL
Homosalate ( UNII: V06SV4M95S)( Homosalate - UNII: V06SV4M95S ) 3.5 gin 70 mL
Octocrylene ( UNII: 5A68WGF6WM)( Octocrylene - UNII: 5A68WGF6WM ) 2.1 gin 70 mL

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Alcohol ( UNII: 3K9958V90M)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part352 USA

Labeler - DMS INTERNATIONAL CO., LTD.( 688309194)

Establishment

Name ID/FEI Business Operations
DMS INTERNATIONAL CO., LTD. 688309194 repack( 70265-090)

Package label.principal display panel