COVER PERFECTION CONCEALER FOUNDATION 02- titanium dioxide, zinc oxide cream 
The Saem International 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: Titanium Dioxide 14.82%, Zinc Oxide 6.30%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Phenyl Trimethicone, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, PEG-10 Dimethicone, Niacinamide, Butylene Glycol Dicaprylate/Dicaprate, Glycerin, Talc, CI 77492, Dimethicone/Vinyl Dimethicone Crosspolymer, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride, Disteardimonium Hectorite, Aluminum Hydroxide, Dimethicone, Stearic Acid, Beeswax, Silica, 1,2-Hexanediol, Triethoxycaprylylsilane, Portulaca Oleracea Extract, CI 77491, Panthenol, Hydroxyacetophenone, Triethyl Citrate, Polymethylsilsesquioxane, Polyhydroxystearic Acid, Butyl Avocadate, Adansonia Digitata Seed Extract, CI 77499, Phyllostachis Bambusoides Juice, Fragrance, Disodium EDTA, Adenosine, Ethylhexyl Palmitate, Lecithin, Isopropyl Palmitate, Isostearic Acid, Lavandula Angustifolia (Lavender) Flower Extract, Castanea Crenata (Chestnut) Shell Extract, Polyglyceryl-3 Polyricinoleate, Uncaria Gambir Extract, Sanguisorba Officinalis Root Extract, Nelumbo Nucifera Flower Extract, Pelargonium Graveolens Extract, Cinnamomum Zeylanicum Bark Extract, Caprylic/Capric Triglyceride, Alcohol, Phenoxyethanol, Pistacia Lentiscus (Mastic) Gum, Aloe Barbadensis Leaf Extract, Biosaccharide Gum-1, Camellia Sinensis Leaf Extract, Ethylhexylglycerin, Amber Extract, Caprylyl Glycol, Propyl Gallate

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only

1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.

1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.

2) In case of having the same symptoms above on the part you put this product on by direct sunlight.

2. You are banned to use it on the part where you have a scar, eczema, or dermatitis.

3. In case of getting it into your eyes, you have to wash it immediately.

4. Keep out of reach of babies and children.

DESCRIPTION

Uses:

Helps prevent sunburn.

Directions:

Using the slanted tip of the applicator, dot or sweep the product onto skin and gently blend in with fingers using a pressing motion. For extra touch-up, use the pointy tip to apply over blemishes and pat with fingers to blend well.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

COVER PERFECTION CONCEALER FOUNDATION 02 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70341-695
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide5.63 g  in 38 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.39 g  in 38 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70341-695-021 in 1 CARTON05/01/201811/01/2019
1NDC:70341-695-0138 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 finalpart35205/01/201811/01/2019
Labeler - The Saem International Co., Ltd. (689402402)
Registrant - The Saem International Co., Ltd. (689402402)
Establishment
NameAddressID/FEIBusiness Operations
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory688235645manufacture(70341-695)

Revised: 12/2019
 
The Saem International Co., Ltd.