BAROX EXTRAORDINARY MILD SUNBLOCK by Barox Co., Ltd. / Gdk cosmetics Co., Ltd.

BAROX EXTRAORDINARY MILD SUNBLOCK by

Drug Labeling and Warnings

BAROX EXTRAORDINARY MILD SUNBLOCK by is a Otc medication manufactured, distributed, or labeled by Barox Co., Ltd., Gdk cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

----------

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

BAROX EXTRAORDINARY MILD SUNBLOCK 
octinoxate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55692-260
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	3.50 g  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.65 g  in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.50 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55692-260-02	1 in 1 CARTON	09/01/2018	03/01/2019
1	NDC: 55692-260-01	50 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2018	03/01/2019

Labeler - Barox Co., Ltd. (688380051)

Registrant - Barox Co., Ltd. (688380051)

Establishment
Name	Address	ID/FEI	Business Operations
Gdk cosmetics Co., Ltd.		557821946	manufacture(55692-260)

Revised: 11/2019

Document Id: 371f7e14-c5ae-4134-8e18-10429a8f28af

34390-5

Set id: 8fb4d6e6-0e8c-41fd-b48d-4719c02d6303

Version: 2

Effective Time: 20191107

 

Barox Co., Ltd.