Drug Labeling and Warnings

Drug Details [pdf]

DERMOESSENTIAL SUN MIST- octinoxate, octisalate, homosalate, octocrylene spray 
DMS INTERNATIONAL CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

DERMOESSENTIAL SUN MIST 
octinoxate, octisalate, homosalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70265-090
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4.9 g  in 70 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.5 g  in 70 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate3.5 g  in 70 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene2.1 g  in 70 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70265-090-0170 mL in 1 CARTON; Type 0: Not a Combination Product02/01/201601/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/201601/02/2019
Labeler - DMS INTERNATIONAL CO., LTD. (688309194)
Registrant - DMS INTERNATIONAL CO., LTD. (688309194)
Establishment
NameAddressID/FEIBusiness Operations
Nowcos.Co.,Ltd689914984manufacture(70265-090)

Revised: 8/2019