Label: BILBOA CAPRI SUNSCREEN SPF 15- avobenzone, octisalate, octocrylene, oxybenzone 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

    Avobenzone 2%, Octisalate 5%,
    Octocrylene 3%, Oxybenzone 2%           Sunscreen

  • PURPOSE

    Uses

    - Helps prevent sunburn
    - Higher SPF gives more sunburn protection
    - Provides moderate 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, Butyloctyl Salicylate, Dicaprylyl Carbonate, Stearyl/octadodecyl Citrate Crosspolymer, Ethylhexyl Methoxycrylene, Pentaerythrityl Distearate, Dimethicone, Phenoxyethanol, Sodium Polyacrylate, Sodium Stearoyl Glutamate, Fragrance, Ethylhexylglycerin, Tropolone, Disodium Edta, Tetrasodium Edta, Benzyl Salicylate, Geraniol, Aloe Barbadensis Leaf Extract, Coumarin, Maltodextrin.

  • QUESTIONS

    Questions? visit www.cadeyusa.com

  • DESCRIPTION

    Bilboa Capri, inspired by one of the best-known Mediterranean islands, comes from Cadey’s Italian experience. The 15 Lotion provides UVA/UVB sunscreen protection against sunburn. It is also enriched with moisturizes and soothing Aloe and Vitamin E. 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 Caprl  Sunscreen Lotion  Broad spectrum UVA/UVB protection  Moisturizing and soothing formula  15 SPF  Water-resistant With Aloe  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  00300 9

  • PRINCIPAL DISPLAY PANEL

    BilboaCapri15A
    BilboaCapri15B
  • INGREDIENTS AND APPEARANCE
    BILBOA CAPRI SUNSCREEN SPF 15 
    avobenzone, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76070-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mL  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    GERANIOL (UNII: L837108USY)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COUMARIN (UNII: A4VZ22K1WT)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76070-100-061 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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