3CE EYE SHADOW PALETTE SIENNA- titanium dioxide powder

3CE EYE SHADOW PALETTE SIENNA by

Drug Labeling and Warnings

3CE EYE SHADOW PALETTE SIENNA by is a Otc medication manufactured, distributed, or labeled by Nanda Co., Ltd, Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Titanium Dioxide 5.9%

INACTIVE INGREDIENT

Inactive Ingredients:

A) Mica (CI 77019), Talc, Glass, Neopentyl Glycol Diethylhexanoate, Iron Oxides (CI 77491), Phenyl Trimethicone, Calcium Aluminum Borosilicate, Nylon-12, Diisostearyl Malate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Octyldodecyl Stearoyl Stearate, Isostearyl Neopentanoate, Magnesium Myristate, Magnesium Stearate, Carmine (CI 75470), Silica, Polybutene, Iron Oxides (CI 77499), Propanediol, Dimethicone, Ultramarines (CI 77007), Triethoxycaprylylsilane, Sodium Dehydroacetate, Hydrogenated Lecithin, Tin Oxide (CI 77861)

B)~D) Mica (CI 77019), Talc, Glass, Titanium Dioxide (CI 77891), Neopentyl Glycol Diethylhexanoate, Iron Oxides (CI 77491), Phenyl Trimethicone, Calcium Aluminum Borosilicate, Nylon-12, Diisostearyl Malate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Octyldodecyl Stearoyl Stearate, Isostearyl Neopentanoate, Magnesium Myristate, Magnesium Stearate, Carmine (CI 75470), Silica, Polybutene, Iron Oxides (CI 77499), Propanediol, Dimethicone, Ultramarines (CI 77007), Triethoxycaprylylsilane, Sodium Dehydroacetate, Hydrogenated Lecithin, Tin Oxide (CI 77861)

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

INGREDIENTS AND APPEARANCE

3CE EYE SHADOW PALETTE SIENNA 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60764-066
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.47 g  in 8 g

Inactive Ingredients
Ingredient Name	Strength
Mica (UNII: V8A1AW0880)
Talc (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60764-066-02	1 in 1 CARTON	08/20/2016
1	NDC: 60764-066-01	8 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/20/2016

Labeler - Nanda Co., Ltd (557816075)

Registrant - Nanda Co., Ltd (557816075)

Establishment
Name	Address	ID/FEI	Business Operations
Nanda Co., Ltd		557816075	repack(60764-066)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(60764-066)