COVER PERFECTION SMART CONCEALER KIT- 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 24.00%

INACTIVE INGREDIENT

Inactive ingredients:

Color 1 : Trimethylolpropane Triethylhexanoate, Diisostearyl Malate, Ethylhexyl Palmitate, Polybutene, Talc, Mica (CI 77019), Bis-Diglyceryl Polyacyladipate-2, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Ceresin, Polyethylene, Methyl Methacrylate Crosspolymer, Iron Oxides (CI 77492), Silica, Cetyl PEG/PPG-10/1 Dimethicone, Microcrystalline Wax, Sorbitan Isostearate, VP/Hexadecene Copolymer, Silica Dimethyl Silylate, Silica Silylate, Iron Oxides (CI 77491), Triethoxycaprylylsilane, Iron Oxides (CI 77499), Fragrance(Parfum), Caprylyl Glycol, Astrocaryum Murumuru Seed Butter, Bertholletia Excelsa Seed Oil

Color 2 : Trimethylolpropane Triethylhexanoate, Diisostearyl Malate, Ethylhexyl Palmitate, Polybutene, Talc, Mica (CI 77019), Bis-Diglyceryl Polyacyladipate-2, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Ceresin, Polyethylene, Iron Oxides (CI 77492), Methyl Methacrylate Crosspolymer, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Microcrystalline Wax, Sorbitan Isostearate, VP/Hexadecene Copolymer, Silica Dimethyl Silylate, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Silica Silylate, Triethoxycaprylylsilane, Fragrance(Parfum), Caprylyl Glycol, Astrocaryum Murumuru Seed Butter, Bertholletia Excelsa Seed Oil

Color 3 : Trimethylolpropane Triethylhexanoate, Diisostearyl Malate, Ethylhexyl Palmitate, Iron Oxides (CI 77492), Polybutene, Mica (CI 77019), Bis-Diglyceryl Polyacyladipate-2, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Polyethylene, Ceresin, Talc, Iron Oxides (CI 77491), Cetyl PEG/PPG-10/1 Dimethicone, Microcrystalline Wax, Silica, Sorbitan Isostearate, VP/Hexadecene Copolymer, Silica Dimethyl Silylate, Iron Oxides (CI 77499), Silica Silylate, Triethoxycaprylylsilane, Fragrance(Parfum), Caprylyl Glycol, Astrocaryum Murumuru Seed Butter, Bertholletia Excelsa Seed Oil

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 mix and create customized colors for your skin tone and imperfections. Apply on dark circles or blemishes and gently blend in using a pressing motion.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

COVER PERFECTION SMART CONCEALER KIT 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70341-693
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.00 g  in 4.2 g
Inactive Ingredients
Ingredient NameStrength
TRIMETHYLOLPROPANE TRIETHYLHEXANOATE (UNII: B952ZGW1IL)  
Diisostearyl Malate (UNII: QBS8A3XZGQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70341-693-021 in 1 CARTON05/01/201811/01/2019
1NDC:70341-693-014.2 g 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
Cosmax, Inc.689049693manufacture(70341-693)

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