Drug Labeling and Warnings

Drug Details [pdf]

DERMOESSENTIAL SUN RESCUE- octinoxate, octisalate, avobenzone cream 
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 7.2%, Ethylhexyl Salicylate 4.8%, Butyl Methoxydibenzoylmethane 3.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Dipropylene Glycol, Phenylbenzimidazole Sulfonic Acid, Caprylic/Capric Triglyceride, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Glyceryl Stearate, Cetearyl Alcohol, Cetearyl Olivate, Polyacrylate-13, Sorbitan Olivate, Sodium Hydroxide, Tocopheryl Acetate, Dimethicone, Panthenol, Polyisobutene, PEG-100 Stearate, Methylparaben, Chlorphenesin, Propylparaben, Sorbitan Stearate, Disodium EDTA, Polysorbate 20, Sorbitan Isostearate, BHT, Butylparaben, Butylene Glycol, Malpighia Emarginata (Acerola) Fruit Extract, Caviar Extract, Propylene Glycol, Glycerin, Morus Alba Root Extract, Sodium Ascorbyl Phosphate, Allantoin, Alcohol, Glycyrrhiza Glabra (Licorice) Root Extract, Anthemis Nobilis Flower Extract, Phenoxyethanol, Lecithin, Polysorbate 80, Ubiquinone, Centella Asiatica Extract, Ethylhexylglycerin, Wine Extract

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: Using at the end stage of basic skin care, take a proper amount of it and apply forehead, cheeks, chin and nose tap gently until absorbed. Reapply as needed.

Dosage & Administration: Use immediately after opening

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

DERMOESSENTIAL SUN RESCUE 
octinoxate, octisalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70265-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.6 g  in 50 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.4 g  in 50 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Dipropylene Glycol (UNII: E107L85C40)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70265-080-0150 g 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
DMS INTERNATIONAL CO., LTD.688309194manufacture(70265-080)

Revised: 8/2019