3CE DRAWING LIP PEN NEED- titanium dioxide lipstick

3CE DRAWING LIP PEN NEED by

Drug Labeling and Warnings

3CE DRAWING LIP PEN NEED by is a Otc medication manufactured, distributed, or labeled by Nanda Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Titanium Dioxide 24.5%

INACTIVE INGREDIENT

Inactive Ingredients: Mica, Hydrogenated Coco-Glycerides, Rhus Succedanea Fruit Wax, Stearic Acid, Triethylhexanoin, Iron Oxides(CI 77492), Hydrogenated Castor Oil, Lanolin, Acetylated Sucrose Distearate, Red 6 (CI 15850), Iron Oxides(CI 77491), Microcrystalline Wax, Iron Oxides(CI 77499), Butylparaben

PURPOSE

Purpose: Sunscreen

CAUTION

CAUTION: 1. If following problems occur upon using the product, stop use immediately; further use may worsen the symptoms. Consult with a dermatologist if necessary. 1) Red spots, swelling, itchiness, irritation, or any other irregularities. 2) If applied area shows above symptoms when exposed to direct sunlight. 2. Do not use on areas with skin conditions such as open wound, eczema, or any skin disease. 3. Notes on storage and handling 1) Always put the lid back on after use 2) Keep away from reach of children 3) Keep away from high/low temperature or direct sunlight

DESCRIPTION

INSTRUCTIONS: Pencil-type lipstick that glides on lips like a crayon.

Directions: Hold the pencil flat against the lip and apply by tracing your natural lip line, moving towards to fill in.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

3CE DRAWING LIP PEN NEED 
titanium dioxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60764-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.26 g  in 1.1 g

Inactive Ingredients
Ingredient Name	Strength
Mica (UNII: V8A1AW0880)
Stearic Acid (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60764-107-02	1 in 1 CARTON	08/01/2016
1	NDC: 60764-107-01	1.1 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	manufacture(60764-107)