Cover Perfection Tip Concealer Contour Beige by The Saem International Co., Ltd. / Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory

Cover Perfection Tip Concealer Contour Beige by

Drug Labeling and Warnings

Cover Perfection Tip Concealer Contour Beige by is a Otc medication manufactured, distributed, or labeled by The Saem International Co., Ltd., Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COVER PERFECTION TIP CONCEALER CONTOUR BEIGE- titanium dioxide 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 22.94%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Phenyl Trimethicone, Iron Oxides (CI 77492), Talc (CI 77718), Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, PVP, PEG-10 Dimethicone, Iron Oxides (CI 77491), Disteardimonium Hectorite, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Sodium Chloride, Triethoxycaprylylsilane, Iron Oxides (CI 77499), Aluminum Hydroxide (CI 77002), Stearic Acid, Phenoxyethanol, Chlorphenesin, Perfume, Dimethicone, Mannitol, Yeast Extract, Glycogen, Magnesium Ascorbyl Phosphate, Gentiana Lutea Root Extract, Achillea Millefolium Extract, Artemisia Vulgaris Extract, Arnica Montana Flower Extract

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:

Use the applicator to apply on dark circles and gently blend in with fingers using a pressing motion. Apply anywhere on the face for brightening & smoothening effect and sheer coverage.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COVER PERFECTION TIP CONCEALER CONTOUR BEIGE 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-701
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.49 g  in 6.5 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: 70341-701-01	6.5 g in 1 CONTAINER; Type 0: Not a Combination Product	05/01/2018	11/01/2019

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(70341-701)

Revised: 12/2019

Document Id: 8ba020be-ac36-4a4b-a36b-50ae9f102c37

34390-5

Set id: 63f10d5d-bbfe-493f-9e0a-c2c98372b890

Version: 2

Effective Time: 20191227

 

The Saem International Co., Ltd.