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Bellagio Lip Moisturizer SPF 15 (Lifetech Resources, LLC)

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OINTMENT 4.25 g in 1 TUBE (65643-333-20) Label Information

Complete Bellagio Lip Moisturizer SPF 15 Information

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS


  • ACTIVE INGREDIENTS

    Octinoxate 7.0%, Octisalate 4.0%, Oxybenzone 3.5%.


  • PURPOSE

    Sunscreen.


  • USE

    Helps prevent sunburn. Higher SPF gives more sunburn protection.


  • DIRECTIONS FOR USE

    Apply evenly and liberally on to lips.


  • INACTIVE INGREDIENTS

    Ricinus Communis (Castor) Seed Oil, Petrolatum, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Cetearyl Alcohol, Tribehenin, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea Butter), Tocopheryl Acetate, Stevioside.


  • PRINCIPAL DISPLAY PANEL - 4.25G Tube Label

    BELLAGIO®
    LIP
    MOISTURIZER
    SPF 15

    0.15 OZ /
    4.25G

    Principal Display Panel - 4.25G Tube Label

  • INGREDIENTS AND APPEARANCE
    BELLAGIO LIP MOISTURIZER SPF 15 
    octinoxate, octisalate, and oxybenzone ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65643-333
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 64.26 mg  in 1 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 36.72 mg  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 32.13 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Castor Oil (UNII: D5340Y2I9G)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Candelilla Wax (UNII: WL0328HX19)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Tribehenin (UNII: 8OC9U7TQZ0)  
    Jojoba Oil (UNII: 724GKU717M)  
    Shea Butter (UNII: K49155WL9Y)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Product Characteristics
    Color YELLOW Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65643-333-20 4.25 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 02/01/2009
    Labeler - Lifetech Resources, LLC (622559110)
    Establishment
    Name Address ID/FEI Business Operations
    Lifetech Resources, LLC 622559110 MANUFACTURE