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

Image of containerImage of container

COVER PERFECTION TIP CONCEALER CONTOUR BEIGE 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70341-701
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.49 g  in 6.5 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70341-701-016.5 g in 1 CONTAINER; Type 0: Not a Combination Product05/01/201811/01/2019
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(70341-701)

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