Cover Perfection Li quid Concealer 02 Rich Beige by The Saem International Co., Ltd. / Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory

Cover Perfection Li quid Concealer 02 Rich Beige by

Drug Labeling and Warnings

Cover Perfection Li quid Concealer 02 Rich 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 LI QUID CONCEALER 02 RICH BEIGE- titanium dioxide liquid 
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.

----------

ACTIVE INGREDIENT

Active ingredients: Titanium Dioxide 12.00%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Dimethicone, Phenyl Trimethicone, Octyldodecanol, Butylene Glycol, PEG-10 Dimethicone, Iron Oxides (CI 77492), Niacinamide, Quaternium-18 Bentonite, Sodium Chloride, Sorbitan Sesquioleate, Stearic Acid, Iron Oxides (CI 77491), Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Disteardimonium Hectorite, Triethoxycaprylylsilane, Aluminum Hydroxide, Chlorphenesin, Phenoxyethanol, Iron Oxides (CI 77499), Propylene Carbonate, Adenosine, Disodium EDTA, Sodium Hyaluronate, Olea Europaea (Olive) Fruit Oil, Sodium Potassium Aluminum Silicate, Gentiana Lutea Root Extract, Glycogen, Magnesium Ascorbyl Phosphate, Mannitol, Achillea Millefolium Extract, Artemisia Vulgaris Extract, Arnica Montana Flower Extract, Yeast Extract, Silica, Perfume

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:

Apply a small dot of product to finger or concealing brush. Pat on and blend, building coverage as needed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

COVER PERFECTION LI QUID CONCEALER 02 RICH BEIGE 
titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70341-692
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.80 g  in 15 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Dimethicone (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70341-692-021 in 1 CARTON05/01/201811/01/2019
1NDC: 70341-692-0115 mL 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(70341-692)

Revised: 12/2019
Document Id: 740dd988-65ee-4c5d-91f9-dde671be1293
Set id: 630539b6-82d8-4b98-a121-891bc302dbac
Version: 2
Effective Time: 20191227
 
The Saem International Co., Ltd.