3CE LIP COLOR 805 R 19- titanium dioxide lipstick

3CE LIP COLOR 805 R 19 by

Drug Labeling and Warnings

3CE LIP COLOR 805 R 19 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 3.1%

INACTIVE INGREDIENT

Inactive Ingredients: Diisostearyl Malate, Triethylhexanoin, EthylhexylHydroxystearate, IsononylIsononanoate, Silica, Microcrystalline Wax, Ceresin, Ozokerite, DiglycerylSebacate/Isopalmitate, Octyldodecanol, Alumina, Red 28 Lake (CI 45410), Polyglyceryl-2 Triisostearate, Dicalcium Phosphate, VP/Hexadecene Copolymer, SorbitanIsostearate, Euphorbia Cerifera (Candelilla) Wax, Mica (CI 77019), Polyglyceryl-2 Diisostearate, Polyethylene, Red 7 (CI 15850:1), PentaerythritylTetraisostearate, Silica Dimethyl Silylate, Yellow 6 Lake (CI 15985), Tocopheryl Acetate, Blue 1 Lake (CI 42090), 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 805 R 19 
titanium dioxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60764-056
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.10 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: 60764-056-02	1 in 1 CARTON	08/01/2016
1	NDC: 60764-056-01	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(60764-056)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(60764-056)