3CE DRAWING LIP PEN BORN RED (TITANIUM DIOXIDE) LIPSTICK [NANDA CO., LTD]

3CE DRAWING LIP PEN BORN RED (TITANIUM DIOXIDE) LIPSTICK [NANDA CO., LTD]
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NDC 60764-101-01, 60764-101-02
Set ID efa7b1de-2566-4d64-94b0-8bc50032d55e
Category HUMAN OTC DRUG LABEL
Packager Nanda Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • 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

  • INGREDIENTS AND APPEARANCE
    3CE DRAWING LIP PEN BORN RED 
    titanium dioxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.01 g  in 1.1 g
    Inactive Ingredients
    Ingredient NameStrength
    Mica (UNII: V8A1AW0880)  
    Triethylhexanoin (UNII: 7K3W1BIU6K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-101-021 in 1 CARTON08/01/2016
    1NDC:60764-101-011.1 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(60764-101)

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