3CE SHIMMER PINK- titanium dioxide stick

3CE SHIMMER PINK by

Drug Labeling and Warnings

3CE SHIMMER PINK 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 4.0%

INACTIVE INGREDIENT

Inactive Ingredients: Triethylhexanoin, Silica, Caprylic/Capric Triglyceride, Dimethicone, IsotridecylIsononanoate, Synthetic Fluorphlogopite, EthylhexylPalmitate, Ceresin, Ozokerite, Polyethylene, DiglycerylSebacate/Isopalmitate, VP/Hexadecene Copolymer, Hydrogenated Vegetable Oil, Microcrystalline Wax, HDI/TrimethylolHexyllactoneCrosspolymer, Hydroxyapatite, Silica Silylate, Methicone, Mica (CI 77019), Polyglyceryl-2 Triisostearate, Methylparaben, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Tin Oxide (CI 77861), Propylparaben, Diisostearyl Malate, AstrocaryumMurumuru Seed Butter, TheobromaGrandiflorum Seed Butter, Aloe Barbadensis Leaf Juice, Dimethicone/Vinyl DimethiconeCrosspolymer, Polyurethane-40, Potassium Sorbate, Sodium Benzoate

PURPOSE

Purpose: Sunscreen

CAUTION

CAUTION: 1. Discontinue use and consult a doctor when - your skin irritates, swells, itches, shows spots on areas applied - your skin reacts similarly with above when exposed to sunlight 2. Avoid applying on wounded, irritated, troubled areas 3. After the use - keep the cap closed - keep it out of children's reach - keep it away from expose to sunlight, high and low temperatures

DESCRIPTION

INSTRUCTIONS: Shimmer stick that helps create a three-dimensional look with its subdued pearly light.

Directions: Apply on T& C-zone, or other areas to highlight. Then pat around with your hands

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

3CE SHIMMER PINK 
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60764-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.4 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
Triethylhexanoin (UNII: 7K3W1BIU6K)
Dimethicone (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60764-013-02	1 in 1 CARTON	08/15/2016
1	NDC: 60764-013-01	10 g in 1 BOTTLE, PLASTIC; 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	08/15/2016

Labeler - Nanda Co., Ltd (557816075)

Registrant - Nanda Co., Ltd (557816075)

Establishment
Name	Address	ID/FEI	Business Operations
Nanda Co., Ltd		557816075	repack(60764-013)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(60764-013)