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Bellagio Sunscreen SPF 15 (Lifetech Resources, LLC)

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LOTION 237 mL in 1 TUBE (65643-326-15) Label Information

Complete Bellagio Sunscreen SPF 15 Information

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS


  • ACTIVE INGREDIENTS

    Octinoxate 7.5%, Avobenzone 2.0%


  • 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, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Glycerin, Dimethicone, Polysorbate 60, Sorbitan Stearate, Aminomethyl Propanol, Potassium Cetyl Phosphate, Cetearyl Alcohol, Xanthan Gum, Betaine, Butyrospermum Parkii (Shea Butter), Squalane, Chamomilla, Recutita (Matricaria) Flower Extract, Calendula Officinalis Flower Extract, Lecithin, Panthenol, Sodium PCA, Tocopheryl Acetate, Sodium Hyaluronate, Ascorbyl Palmitate, Silica, Butylene Glycol, Imidazolidinyl Urea, Sodium Benzoate, Disodium EDTA, Potassium Sorbate, Fragrance.


  • PRINCIPAL DISPLAY PANEL - 237 ML Tube Label

    BELLAGIO®
    SUNSCREEN
    LOTION
    SPF 15

    8 FL OZ / 237 ML

    PRINCIPAL DISPLAY PANEL - 237 ML Tube Label

  • INGREDIENTS AND APPEARANCE
    BELLAGIO SUNSCREEN SPF 15 
    octinoxate and avobenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65643-326
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 76.8 mg  in 1 mL
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 20.48 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Sorbitan Monostearate (UNII: NVZ4I0H58X)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Betaine (UNII: 3SCV180C9W)  
    Shea Butter (UNII: K49155WL9Y)  
    Squalane (UNII: GW89575KF9)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Calendula Officinalis Flower (UNII: P0M7O4Y7YD)  
    Panthenol (UNII: WV9CM0O67Z)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Imidurea (UNII: M629807ATL)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65643-326-15 237 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