TROIAREUKE ACSEN UV PROTECTOR ESSENCE- octinoxate, homosalate, octisalate, titanium dioxide cream 
Mk Universal Inc.

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: 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

Image of carton

TROIAREUKE ACSEN UV PROTECTOR ESSENCE 
octinoxate, homosalate, octisalate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71972-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE1.5 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.5 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.74 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71972-010-021 in 1 CARTON12/01/2017
1NDC:71972-010-0150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/201706/10/2021
Labeler - Mk Universal Inc. (694259815)

Revised: 6/2021
 
Mk Universal Inc.