EIGHT HOUR CREAM LIP PROTECTANT SHEER TINT SPF 15 BLUSH (PETROLATUM) STICK [ELIZABETH ARDEN, INC]

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EIGHT HOUR CREAM LIP PROTECTANT SHEER TINT SPF 15 BLUSH (PETROLATUM) STICK [ELIZABETH ARDEN, INC]
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NDC 67938-1408-1, 67938-1408-2
Set ID b8397ddc-8fc7-442d-847c-e7ba382d2d2d
Category HUMAN OTC DRUG LABEL
Packager Elizabeth Arden, Inc
Generic Name
Product Class
Product Number
Application Number PART352
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  • DESCRIPTION

    Moisturizes, softens and smooths lips. Provides antioxidant protection with vitamin E. SPF 15 protects against UV exposure. Provides a sheer wash of color in 6 translucent shades. Dermatologist, clinically and allergy tested.

  • INDICATIONS AND USAGE

    To Use: Apply liberally as often as necessary.

  • WARNINGS

    Warning: If condition worsens or does not improve within 7 days, consult a physician.

  • OTC - ACTIVE INGREDIENT

    Active Ingredients: Petrolatum, 30.2% w/w, Padimate O, 8.0% w/w, Oxybenzone, 3.0% w/w.

  • INACTIVE INGREDIENT

    Other Ingredients: Ozokerite, Ricinus Communis (Castor) Seed Oil, Glyceryl Rosinate, Cetyl Lactate, Lanolin Oil, Myristyl Lactate, Cetyl Acetate, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera/Cire De Candelilla, Copernicia Cerifera (Carnauba) Wax/Cer Carnauba/Cire De Carnauba, Beeswax/Cera Alba/Cire D'Abeille, Tocopherol, Acetylated Lanolin Alcohol, Methylstyrene/Vinyltoluene Copolymer, Microcrystalline Wax/Cera Microcristallina/Cire Microcristalline, BHT, Vegetable Oil/Olus/Huile Vegetale, Zea Mays (Corn) Oil, Citral Citronellol, Geraniol, Limonene, Linalool, Butylparaben, Propylparaben.

    May Contain: Blue 1 Lake (CI 42090), Iron Oxides (CI 77491, CI 77499, CI 77492), Red 6 Lake (CI 15850), Red 7 Lake (CI 15850), Red 21 Lake (CI 45380), Red 27 Lake (CI 45410), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Yellow 6 Lake (CI15985).

  • DOSAGE & ADMINISTRATION

    Apply to lips.

  • OTC - KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTC - PURPOSE

    SPF 15 protects against UV exposure.

  • OTC - WHEN USING

    Note condition.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Sheer Tint Box

    Sheer Tint Base Label

  • INGREDIENTS AND APPEARANCE
    EIGHT HOUR CREAM LIP PROTECTANT SHEER TINT SPF 15 BLUSH 
    petrolatum stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1408
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1.117 g  in 3.7 g
    PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O0.296 g  in 3.7 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.111 g  in 3.7 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    MYRISTYL LACTATE (UNII: 1D822OC34X)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    CORN OIL (UNII: 8470G57WFM)  
    Product Characteristics
    ColorRED (Blush) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-1408-11 in 1 BOX
    1NDC:67938-1408-23.7 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/28/2006
    Labeler - Elizabeth Arden, Inc (849222187)
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