3CE DRAWING LIP PEN BORN RED- titanium dioxide lipstick
Nanda Co., Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Active Ingredient: Titanium Dioxide 1.7%

INACTIVE INGREDIENT

Inactive Ingredients: Red 7 Lake (CI 15850), Mica, Hydrogenated Coco-Glycerides, Rhus Succedanea Fruit Wax, Stearic Acid, Triethylhexanoin, Hydrogenated Castor Oil, Lanolin, Acetylated Sucrose Distearate, 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

Image of carton

3CE DRAWING LIP PEN BORN RED
titanium dioxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60764-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.01 g in 1.1 g

Ingredient Name	Strength
Inactive Ingredients
Mica (UNII: V8A1AW0880)
Triethylhexanoin (UNII: 7K3W1BIU6K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60764-101-02	1 in 1 CARTON	08/01/2016
1	NDC:60764-101-01	1.1 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/01/2016

Labeler - Nanda Co., Ltd (557816075)

Registrant - Nanda Co., Ltd (557816075)

Name	Address	ID/FEI	Business Operations
Establishment
Nanda Co., Ltd		557816075	manufacture(60764-101)