Cover Perfection Concealer Foundation 1.5 by The Saem International Co., Ltd. / Cosmecca Korea Co., Ltd.

Cover Perfection Concealer Foundation 1.5 by

Drug Labeling and Warnings

Cover Perfection Concealer Foundation 1.5 by is a Otc medication manufactured, distributed, or labeled by The Saem International Co., Ltd., Cosmecca Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COVER PERFECTION CONCEALER FOUNDATION 1.5- 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:

Cyclopentasiloxane, Water, Phenyl Trimethicone, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Butylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone, Niacinamide, 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, CI 77491, Triethoxycaprylylsilane, Portulaca Oleracea Extract, Panthenol, Hydroxyacetophenone, Triethyl Citrate, Polymethylsilsesquioxane, CI 77499, Polyhydroxystearic Acid, Butyl Avocadate, Adansonia Digitata Seed Extract, 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

COVER PERFECTION CONCEALER FOUNDATION 1.5 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-696
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	5.63 g  in 38 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.39 g  in 38 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70341-696-02	1 in 1 CARTON	05/01/2018	11/01/2019
1	NDC: 70341-696-01	38 g 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	05/01/2018	11/01/2019

Labeler - The Saem International Co., Ltd. (689402402)

Registrant - The Saem International Co., Ltd. (689402402)

Establishment
Name	Address	ID/FEI	Business Operations
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory		688235645	manufacture(70341-696)

Revised: 12/2019

Document Id: bbc91b91-41d0-4e99-a17b-587c230b3b1e

34390-5

Set id: 3eda7e50-6000-4f88-8290-b8c477f521ed

Version: 2

Effective Time: 20191227

 

The Saem International Co., Ltd.