3CE DRAWING LIP PEN MAYHAP- 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 24.5%

INACTIVE INGREDIENT

Inactive Ingredients: Red 27 Lake (CI 45410), Hydrogenated Coco-Glycerides, Rhus Succedanea Fruit Wax, Stearic Acid, Mica, Hydrogenated Castor Oil, Triethylhexanoin, Yellow 6 Lake (CI 15985), Acetylated Sucrose Distearate, Red 7 Lake (CI 15850), Lanolin, Microcrystalline Wax, Red 6 Lake (CI 15850), 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 MAYHAP 
titanium dioxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.26 g  in 1.1 g
Inactive Ingredients
Ingredient NameStrength
Stearic Acid (UNII: 4ELV7Z65AP)  
Mica (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60764-106-021 in 1 CARTON08/01/2016
1NDC:60764-106-011.1 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/2016
Labeler - Nanda Co., Ltd (557816075)
Registrant - Nanda Co., Ltd (557816075)
Establishment
NameAddressID/FEIBusiness Operations
Nanda Co., Ltd557816075manufacture(60764-106)

Revised: 10/2016
Document Id: f640f40f-117c-4821-8edb-fdea8400e66d
Set id: 03c9f9e2-15ff-4253-87e0-02df68b4706d
Version: 1
Effective Time: 20161013
 
Nanda Co., Ltd