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Bellagio Sunscreen SPF 45 (Lifetech Resources, LLC)

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LOTION 237 mL in 1 TUBE (65643-335-18) Label Information

Complete Bellagio Sunscreen SPF 45 Information

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS


  • ACTIVE INGREDIENTS

    Homosalate 14.00%, Octinoxate 6.50%, Octisalate 5.00%, Oxybenzone 5.00%, Zinc Oxide 2.74%


  • 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, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Polysorbate 60, Polysorbate 20, Glycerin, Cetearyl Alcohol, Ceteareth-20, Sorbitan Stearate, Potassium Cetyl Phosphate, Dimethicone, Butyrospermum Parkii (Shea Butter), Squalane, Sodium PCA, Panthenol, Tocopheryl Acetate, Xanthan Gum, Triethoxycaprylylsilane, Disodium EDTA, Sodium Benzoate, Potassium Sorbate, Imidazolidinyl Urea.


  • PRINCIPAL DISPLAY PANEL - 237 ML Tube Label

    BELLAGIO®
    SUNSCREEN
    LOTION
    SPF 45

    8 FL OZ / 237 ML

    Principal Display Panel - 237 ML Tube Label

  • INGREDIENTS AND APPEARANCE
    BELLAGIO SUNSCREEN SPF 45 
    homosalate, octinoxate, octisalate, oxybenzone, and zinc oxide lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65643-335
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 143.22 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 66.495 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 51.15 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 51.15 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 28.03 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Sorbitan Monostearate (UNII: NVZ4I0H58X)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Shea Butter (UNII: K49155WL9Y)  
    Squalane (UNII: GW89575KF9)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Panthenol (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Imidurea (UNII: M629807ATL)  
    OCTYLTRIETHOXYSILANE (UNII: LDC331P08E)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65643-335-18 237 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