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Bellagio Sunscreen SPF 8 (Lifetech Resources, LLC)

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LOTION 237 mL in 1 TUBE (65643-327-16) Label Information

Complete Bellagio Sunscreen SPF 8 Information

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS


  • ACTIVE INGREDIENTS

    Octinoxate 5.0%, Oxybenzone 3.0%


  • PURPOSE

    Sunscreen


  • USE

    Helps prevent sunburn. Higher SPF gives more sunburn protection.


  • DIRECTIONS FOR USE

    Apply evenly and liberally to all exposed areas before sun exposure. Ensure complete coverage. Reapply as needed or after swimming, towel drying, perspiring, or vigorous activity. Ask a doctor before use on children under 6 months of age.


  • WARNING

    For external use only.

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash or irritation develops and lasts.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


  • INACTIVE INGREDIENTS

    Water, Acrylates Copolymer, Ethylhexyl Isononanoate, Caprylic/Capric Triglyceride, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, Ceteareth-20, Potassium Cetyl Phosphate, Polysorbate 60, Sorbitan Stearate, Squalane, Sodium PCA, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Symphytum Officinale Rhizome/Root Extract, Cucumis Sativus (Cucumber) Fruit Extract, Tocopheryl Acetate, Sodium Hyaluronate, Retinyl Palmitate, Aminomethyl Propanol, Disodium EDTA, Sodium Benzoate, Potassium Sorbate, Imidazolidinyl Urea, Fragrance.


  • PRINCIPAL DISPLAY PANEL - 237 ML Tube Label

    BELLAGIO®
    SUNSCREEN
    LOTION
    SPF 8

    8 FL OZ / 237 ML

    PRINCIPAL DISPLAY PANEL - 237 ML Tube Label

  • INGREDIENTS AND APPEARANCE
    BELLAGIO SUNSCREEN SPF 8 
    octinoxate and oxybenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65643-327
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 49.7 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 29.82 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Sorbitan Monostearate (UNII: NVZ4I0H58X)  
    Squalane (UNII: GW89575KF9)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    CHAMOMILE (UNII: FGL3685T2X)  
    COMFREY ROOT (UNII: M9VVZ08EKQ)  
    FRUIT (UNII: C2AIY4ERZC)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Imidurea (UNII: M629807ATL)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65643-327-16 237 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 01/01/2009
    Labeler - Lifetech Resources, LLC (622559110)
    Establishment
    Name Address ID/FEI Business Operations
    Lifetech Resources, LLC 622559110 MANUFACTURE