Label: BILBOA KIDS SUNSCREEN SPF 50 PLUS- homosalate, octisalate, oxybenzone, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 6, 2011

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  • ACTIVE INGREDIENT

    Active Ingredients                                                     Purpose

    Homosalate 13%, Octisalate 3%,
    Oxybenzone 6%, Zinc Oxide 11.52%                         Sunscreen

  • PURPOSE

    Uses
    - Helps prevent sunburn
    - Higher SPF gives more sunburn protection
    - Provides high protection against sunburn
    - Retains SPF after 40 minutes of activity in the water

  • WARNINGS

    Warnings
    For external use only

    UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen

  • WHEN USING

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

  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions
    - Apply generously and evenly before sun exposure and as needed
    - Children under 6 months of age: ask a doctor
    - Reapply as need or after toweling drying, swimming, or perspiring

  • INACTIVE INGREDIENT

    Inactive ingredients Water, Dicaprylyl Carbonate, Butyloctyl Salicylate, Glycerin, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Diisostearate, Hydrogenated Castor Oil, Stearyl/Octadodecyl Citrate Crosspolymer, Potassium Olivoyl Pca, Shorea Stenoptera Seed Butter, Dimethicone, Phenoxyethanol, Magnesium Sulfate, Sodium Chloride, Synthetic Beeswax, Triethoxycaprylylsilane, Fragrance, Ethylhexylglycerin, Stearalkonium Hectorite, Tropolone, Propylene Carbonate, Benzyl Salicylate, Limonene, Linalool, Geraniol, Butylphenyl Methylpropional, Citronellol, Coumarin, Hexyl Cinnamal, Alpha-Isomethyl Ionone, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde.

  • QUESTIONS

    Questions? visit www.cadeyusa.com

  • DESCRIPTION

    Bilboa Kids Sunscreen Lotion Spf 50+ comes from Cadey’s Italian experience and is specifically developed to protect kids’ delicate skin. Provides your child with broad spectrum UVA/UVB protection and water-resistant. Dermatologically tested - Aminobenzoic acid (PABA) - free

    Made In Italy
    Manufactured for Cadey Srl
    Distributed by RBY LLC
    5816 Avian Place
    Concord NC 28025

    cadey

  • PRINCIPAL DISPLAY PANEL

    BILBOA KIDS  6 months of age and up  Sunscreen Lotion  Broad spectrum UVA/UVB protection  Moisturizing and soothing formula  Protects delicate skin against sunburn     50+ SPF  Water-resistant  6.76 fl oz (200 ML)  Made In Italy  Manufactured for Cadey Srl  Distributed by RBY LLC  5816 Avian Place  Concord NC 28025  cadey  8 51055 00306 1

  • PRINCIPAL DISPLAY PANEL

    BilboaKids50ABilboaKids50B

  • INGREDIENTS AND APPEARANCE
    BILBOA KIDS SUNSCREEN SPF 50 PLUS 
    homosalate, octisalate, oxybenzone, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76070-130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE13 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE11.52 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, DL- (UNII: D81QY6I88E)  
    GERANIOL (UNII: L837108USY)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    COUMARIN (UNII: A4VZ22K1WT)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76070-130-061 in 1 PACKAGE
    1200 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/08/2011
    Labeler - Cadey S.r.l. (428414261)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safosa S.p.A.429518632manufacture
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