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Bellagio Childrens Sunscreen SPF 45 (Lifetech Resources, LLC)

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Dosage Form Package Information Links
LOTION 118 mL in 1 TUBE (65643-336-19) Label Information

Complete Bellagio Childrens 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, Caprylic/Capric Triglyceride, Acrylates Copolymer, Cyclopentasiloxane, Polysorbate 60, Cetearyl Alcohol, Ceteareth-20, Glycerin, Potassium Cetyl Phosphate, Sorbitan Stearate, VP/Hexadecene Copolymer, Polysorbate 20, Dimethicone, Butyrospermum Parkii (Shea Butter), Squalane, Panthenol, Sodium PCA, Tocopheryl Acetate, Persea Gratissima (Avocado) Oil, Macadamia Ternifolia Seed Oil, Aloe Barbadensis Leaf Extract, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Xanthan Gum, Triethoxycaprylylsilane, Disodium EDTA, Imidazolidinyl Urea, Sodium Benzoate, Potassium Sorbate.


  • PRINCIPAL DISPLAY PANEL - 118 ML Tube Label

    BELLAGIO®
    CHILDREN'S
    SUNSCREEN
    LOTION
    SPF 45

    4 FL OZ / 118 ML

    Principal Display Panel - 118 ML Tube Label

  • INGREDIENTS AND APPEARANCE
    BELLAGIO CHILDRENS SUNSCREEN SPF 45 
    homosalate, octinoxate, octisalate, oxybenzone, and zinc oxide lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65643-336
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 141.904 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 65.884 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50.68 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 50.68 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 27.773 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Sorbitan Monostearate (UNII: NVZ4I0H58X)  
    Glycerin (UNII: PDC6A3C0OX)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Shea Butter (UNII: K49155WL9Y)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Panthenol (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Avocado (UNII: SDS87L369F)  
    Macadamia Oil (UNII: 515610SU8C)  
    Calendula Officinalis Flower (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    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:65643-336-19 118 mL 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