TROIAREUKE ACSEN UV PROTECTOR ESSENCE- octinoxate, homosalate, octisalate, titanium dioxide cream

TROIAREUKE ACSEN UV PROTECTOR ESSENCE by

Drug Labeling and Warnings

TROIAREUKE ACSEN UV PROTECTOR ESSENCE by is a Otc medication manufactured, distributed, or labeled by Mk Universal Inc., EYESOME. Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Homosalate 3.0%, Ethylhexyl Salicylate 3.0%, Titanium Dioxide 1.49%

INACTIVE INGREDIENT

Inactive ingredients: 

Water, Methylpropanediol, Bis-Ethylhexyloxyphenol Meth oxyphenyl Triazine, Pentylene Glycol, Caprylyl Methicone, Isononyl Isononanoate, Ethylhexyl Triazone, Polyglyceryl-3 Methylglucose Distearate, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cyclopentasiloxane, Phenoxyethanol, SodiumAcrylate /Sodium Acryloyldimethyl Taurate Copolymer, Aluminum Hydroxide, Stearic Acid, Isohexadecane, Dimethicone/Vinyl Dimethicone Crosspolymer, Sorbitan Isostearate, Allantoin, Tocopheryl Acetate, Polysorbate 80, Butylene Glycol, BHT, Sorbitan Oleate, Xanthan Gum, Biosaccharide Gum-4,SodiumHyaluronate,Ethylhexylglycerin,Niacinamide, Aloe Barbadensis Leaf Juice, Propylene Glycol, Hydrolyzed Extensin ,Centella Asiatica Extract, Portulaca Oleracea Extract, Glycerin,Biotin,Cyanocobalamin,AscorbylGlucoside,PEG-40 Hydrogenated Castor Oil, Sodium Benzoate, Potassium Sorbate, PPG-26-Buteth-26, 1,2-Hexanediol, Caprylyl Glycol, Citric Acid, Copper Tripeptide-1, Acetyl Hexapeptide-8, Fragrance, Butylphenyl Methylpropional, Linalool

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only
Avoid contact with eyes.
Discontinue use if signs of irritation or rashes appear.
Replace the cap after use.
Keep Out of Reach of Children.

DESCRIPTION

Uses: Helps prevent sunburn.

Directions:

- Apply liberally 15 minutes before sun exposure

- Reapply at least every 2 hours

- Use a water resistant sunscreen if swimming or sweating

- Children under 6 months : Ask a doctor

Questions: www.mk-corp.co.kr

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TROIAREUKE ACSEN UV PROTECTOR ESSENCE 
octinoxate, homosalate, octisalate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71972-010
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
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	1.50 g  in 50 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	1.50 g  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.74 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Pentylene Glycol (UNII: 50C1307PZG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71972-010-02	1 in 1 CARTON	12/01/2017
1	NDC: 71972-010-01	50 mL in 1 TUBE; 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	12/01/2017

Labeler - Mk Universal Inc. (694259815)

Registrant - Mk Universal Inc. (694259815)

Establishment
Name	Address	ID/FEI	Business Operations
EYESOME. Co.,Ltd.		557795360	manufacture(71972-010)