3CE EYE SHADOW PALETTE SADDLE- titanium dioxide powder

3CE EYE SHADOW PALETTE SADDLE by

Drug Labeling and Warnings

3CE EYE SHADOW PALETTE SADDLE 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 8.5%

INACTIVE INGREDIENT

Inactive Ingredients:

A) Mica (CI 77019), Talc, Iron Oxides (CI 77491), Nylon-12, Neopentyl Glycol Diethylhexanoate, Phenyl Trimethicone, Magnesium Myristate, Magnesium Stearate, Silica, Diisostearyl Malate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Octyldodecyl Stearoyl Stearate, Isostearyl Neopentanoate, Iron Oxides (CI 77492), Polybutene, Propanediol, Dimethicone, Iron Oxides (CI 77499), Triethoxycaprylylsilane, Sodium Dehydroacetate, Hydrogenated Lecithin, Tin Oxide (CI 77861)

B)~D) Mica (CI 77019), Talc, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Nylon-12, Neopentyl Glycol Diethylhexanoate, Phenyl Trimethicone, Magnesium Myristate, Magnesium Stearate, Silica, Diisostearyl Malate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Octyldodecyl Stearoyl Stearate, Isostearyl Neopentanoate, Iron Oxides (CI 77492), Polybutene, Propanediol, Dimethicone, Iron Oxides (CI 77499), 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 SADDLE 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60764-065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.68 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: 60764-065-02	1 in 1 CARTON	08/20/2016
1	NDC: 60764-065-01	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(60764-065)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(60764-065)