Drug Labeling and Warnings

Drug Details [pdf]

DERMOESSENTIAL REVIVAL BALM- titanium dioxide, zinc oxide 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: Titanium Dioxide 10.44%, Zinc Oxide 1.44%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cyclopentasiloxane, Diphenylsiloxy Phenyl Trimethicone, Cyclohexasiloxane, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Hydrogenated Polyisobutene, Talc, Polyglyceryl-4 Isostearate, Glycerin, Hexyl Laurate, Dimethicone/Vinyl Dimethicone Crosspolymer, Butylene Glycol Dicaprylate/Dicaprate, Beeswax, Dimethicone, CI 77492, Ozokerite, Silica, CI 77491, CI 77499, Tocopheryl Acetate, Sorbitan Isostearate, Disteardimonium Hectorite, Triethoxycaprylylsilane, Methylparaben, Sorbitan Olivate, Chlorphenesin, Propylparaben, Zinc Stearate, Sodium Ascorbyl Phosphate, Panthenol, Allantoin, Malpighia Emarginata (Acerola) Fruit Extract, Caviar Extract, Propylene Glycol, Hydrogen Dimethicone, Butylparaben, Propylene Carbonate, Glycyrrhiza Glabra (Licorice) Root Extract, Alcohol, Disodium EDTA, Morus Alba Root Extract, Wine Extract, Phenoxyethanol, Sodium Hyaluronate, Sorbitol, Lecithin, Chamomilla Recutita (Matricaria) Flower Extract, Caprylic/Capric Triglyceride, Ubiquinone, Polysorbate 80, Centella Asiatica Extract, Ethylhexylglycerin, Ethylparaben, Isobutylparaben

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 to 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 REVIVAL BALM 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70265-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide5.22 g  in 50 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.72 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70265-100-0150 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(70265-100)

Revised: 8/2019