BAROX EXTRAORDINARY MILD SUNBLOCK- octinoxate, titanium dioxide, zinc oxide cream 
Barox 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 ingredients: EthylhexylMethoxycinnamate 7.0%, Titanium Dioxide 3.3%, Zinc Oxide 3.0%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclomethicone, Cyclopentasiloxane, Propylene Glycol, Glycerin, PEG-10 Dimethicone, 4-Methylbenzylidene Camphor, Isononyl Isononanoate, 1,2-Hexanediol, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Dimethicone, Triethanolamine, Sorbitan Sesquioleate, Magnesium Sulfate, Dendropanax Morbifera Extract, Aluminum Hydroxide, Stearic Acid, Ethylhexylglycerin, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Dimethyl Sulfone, Nelumbo Nucifera Callus Culture Extract, Aloe Barbadensis Leaf Extract, Butylene Glycol, Maltodextrin, Centella Asiatica Extract, Portulaca Oleracea Extract, Vitex Agnus Castus Extract, Chamomilla Recutita (Matricaria) Flower Extract, Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Salix Alba (Willow) Bark Extract, Lactobacillus/Soybean Ferment Extract, Cinnamomum Cassia Bark Extract, Scutellaria Baicalensis Root Extract, Copper Tripeptide-1

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only.
Avoid contact with eyes.
Keep this and all drugs out of the reach of children.

QUESTIONS

Questions
www.barox.co.kr

DESCRIPTION

Uses:

Protects the skin from both UVA & UVB and helps prevent sunburn.

Directions:

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

BAROX EXTRAORDINARY MILD SUNBLOCK 
octinoxate, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55692-260
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.50 g  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.65 g  in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.50 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55692-260-021 in 1 CARTON09/01/201803/01/2019
1NDC:55692-260-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/201803/01/2019
Labeler - Barox Co., Ltd. (688380051)
Registrant - Barox Co., Ltd. (688380051)
Establishment
NameAddressID/FEIBusiness Operations
Gdk cosmetics Co., Ltd.557821946manufacture(55692-260)

Revised: 11/2019
 
Barox Co., Ltd.