3CE LIP COLOR 804 STAY BY ME- titanium dioxide lipstick

3CE LIP COLOR 804 STAY BY ME by

Drug Labeling and Warnings

3CE LIP COLOR 804 STAY BY ME 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 4.3%

INACTIVE INGREDIENT

Inactive Ingredients: Diisostearyl Malate, Triethylhexanoin, EthylhexylHydroxystearate, IsononylIsononanoate, Silica, Microcrystalline Wax, Ceresin, Ozokerite, Polyglyceryl-2 Triisostearate, DiglycerylSebacate/Isopalmitate, Octyldodecanol, Alumina, Dicalcium Phosphate, VP/Hexadecene Copolymer, SorbitanIsostearate, Euphorbia Cerifera (Candelilla) Wax, Yellow 5 Lake (CI 19140), Red 28 Lake (CI 45410), Polyethylene, PentaerythritylTetraisostearate, Silica Dimethyl Silylate, Mica (CI 77019), Polyglyceryl-2 Diisostearate, Red 7 (CI 15850:1), Yellow 6 Lake (CI 15985), Tocopheryl Acetate, Iron Oxides (CI 77499), MangiferaIndica (Mango) Seed Butter, ButyrospermumParkii (Shea) Butter, Diamond powder, Water, Butylene Glycol, Amethyst Powder, Pearl Powder, Tourmaline, Methylparaben

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: A rich color lipstick that moistly adheres to lips.

Directions: Twist to dispense makeup and apply evenly to lips

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

3CE LIP COLOR 804 STAY BY ME 
titanium dioxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60764-055
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.15 g  in 3.5 g

Inactive Ingredients
Ingredient Name	Strength
Diisostearyl Malate (UNII: QBS8A3XZGQ)
Triethylhexanoin (UNII: 7K3W1BIU6K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60764-055-02	1 in 1 CARTON	08/01/2016
1	NDC: 60764-055-01	3.5 g in 1 BOTTLE; 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	08/01/2016

Labeler - Nanda Co., Ltd (557816075)

Registrant - Nanda Co., Ltd (557816075)

Establishment
Name	Address	ID/FEI	Business Operations
Nanda Co., Ltd		557816075	repack(60764-055)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(60764-055)