3CE EYE SHADOW PALETTE UP CLOSE- titanium dioxide powder 
Nanda 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 Ingredient: Titanium Dioxide 6.5%

INACTIVE INGREDIENT

Inactive Ingredients:

A) Glass, Talc, Mica (CI 77019), Calcium Sodium Borosilicate, Neopentyl Glycol Diethylhexanoate, Phenyl Trimethicone, Nylon-12, Diisostearyl Malate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Octyldodecyl Stearoyl Stearate, Isostearyl Neopentanoate, Magnesium Myristate, Methyl Methacrylate Crosspolymer, Magnesium Stearate, Boron Nitride, Polybutene, Polypropylene, Propanediol, Dimethicone, Carmine (CI 75470), PTFE, Tin Oxide (CI 77861), Lauroyl Lysine, Yellow 5 Lake (CI 19140), Sodium Dehydroacetate, Triethoxycaprylylsilane, Methicone

B)~D) Glass, Talc, Mica (CI 77019), Titanium Dioxide (CI 77891), Calcium Sodium Borosilicate, Neopentyl Glycol Diethylhexanoate, Phenyl Trimethicone, Nylon-12, Diisostearyl Malate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Octyldodecyl Stearoyl Stearate, Isostearyl Neopentanoate, Magnesium Myristate, Methyl Methacrylate Crosspolymer, Magnesium Stearate, Boron Nitride, Polybutene, Polypropylene, Propanediol, Dimethicone, Carmine (CI 75470), PTFE, Tin Oxide (CI 77861), Lauroyl Lysine, Yellow 5 Lake (CI 19140), Sodium Dehydroacetate, Triethoxycaprylylsilane, Methicone

PURPOSE

Purpose: Sunscreen

CAUTION

CAUTION: 1. Keep it out of children's reach 2. Keep it away from expose to sunlight, high and low temperatures.

DESCRIPTION

INSTRUCTIONS: Eye shadow palette with harmonious colors that magnify the hues and light.

Directions: Gently apply on skin with its smooth sliding texture for a clean and luxurious finish

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

3CE EYE SHADOW PALETTE UP CLOSE 
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-063
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.52 g  in 8 g
Inactive Ingredients
Ingredient NameStrength
Talc (UNII: 7SEV7J4R1U)  
Mica (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60764-063-021 in 1 CARTON08/20/2016
1NDC:60764-063-018 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 finalpart35208/20/2016
Labeler - Nanda Co., Ltd (557816075)
Registrant - Nanda Co., Ltd (557816075)
Establishment
NameAddressID/FEIBusiness Operations
Nanda Co., Ltd557816075repack(60764-063)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(60764-063)

Revised: 10/2016
Document Id: 12364afe-25d3-4753-ab51-7b358b5c705c
Set id: 78a4627e-f7cd-40be-a20d-7af195b7930f
Version: 1
Effective Time: 20161004
 
Nanda Co., Ltd