TROIAREUKE CUSHION A PLUS C21 REFILL- titanium dioxide, octinoxate, octisalate, octocrylene, zinc oxide powder 
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: Titanium Dioxide 9.00%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 4.80%, Octocrylene 2.00%, Zinc Oxide 2.00%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Cyclohexasiloxane, C12-15 Alkyl Benzoate, PEG-30 Dipolyhydroxystearate, Niacinamide, Trimethylsiloxysilicate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, PEG-10 Dimethicone, CI 77492, Butylene Glycol, Polypropylsilsesquioxane, Quaternium-18 Bentonite, Sodium Chloride, Dimethicone, CI 77491, Chlorphenesin, Triethoxycaprylylsilane, Aluminum Hydroxide, Parfum, CI 77499, Adenosine, Melaleuca Alternifolia (Tea Tree) Leaf Water, Centella Asiatica Leaf Extract, 1,2-Hexanediol, Ethylhexylglycerin, Calendula Officinalis Flower Extract, Madecassoside

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only

Avoid contact with eyes.

Discontinue use if signs of irritation or rashes appear.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

TROIAREUKE CUSHION A PLUS C21 REFILL 
titanium dioxide, octinoxate, octisalate, octocrylene, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71972-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.35 g  in 15 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate1.05 g  in 15 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.72 g  in 15 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene0.30 g  in 15 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.30 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71972-050-021 in 1 CARTON06/01/201812/01/2018
1NDC:71972-050-0115 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/201812/01/2018
Labeler - Mk Universal Inc. (694259815)
Registrant - Mk Universal Inc. (694259815)
Establishment
NameAddressID/FEIBusiness Operations
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory688235645manufacture(71972-050)

Revised: 12/2018
 
Mk Universal Inc.