Cover Perfection Tip Concealer 02 Rich Beige by The Saem International Co., Ltd.

Cover Perfection Tip Concealer 02 Rich Beige by

Drug Labeling and Warnings

Cover Perfection Tip Concealer 02 Rich Beige by is a Otc medication manufactured, distributed, or labeled by The Saem International Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COVER PERFECTION TIP CONCEALER 02 RICH 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 23.50%

INACTIVE INGREDIENT

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

PURPOSE

Purpose: Sunscreen

WARNINGS

Warning: 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.

Keep out of reach of Children: Keep out of reach of babies and children

DESCRIPTION

Indication & Usage: Apply on spots, freckles or areas with acne and gently spread to create a natural looking flawless skin.

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

COVER PERFECTION TIP CONCEALER 02 RICH BEIGE 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70341-440
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.52 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: 70341-440-016.5 g in 1 CARTON; Type 0: Not a Combination Product12/01/201511/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/201511/01/2019
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(70341-440)

Revised: 12/2019
Document Id: 696ee739-8add-4b33-ba9e-c10233e211cb
Set id: 3e2a8c9c-e408-4c39-8b44-81dd7a00cad6
Version: 2
Effective Time: 20191227
 
The Saem International Co., Ltd.