MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]

MACROANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]
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NDC 63730-340-01
Set ID 1b27d084-d9e3-442d-80bd-cc217fd20315
Category HUMAN OTC DRUG LABEL
Packager Natura Bisse International SA
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients                                                 Purpose

    Avobenzone 3% .................................................... Sunscreen

    Homosalate 10% ................................................... Sunscreen

    Octinoxate 7.5% .................................................... Sunscreen

    Octocrylene 10% ................................................... Sunscreen

    Oxybenzone 3% .................................................... Sunscreen

  • PURPOSE

    Uses

    helps prevent sunburn

  • 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.

  • INDICATIONS & USAGE

    Natura Bissé Barcelona

    C+C Oil-Free MacroAntioxidant Sun Protection

    Broad Spectrum SPF 30

    Net Wet 1 oz 30 ml

  • DOSAGE & ADMINISTRATION

    Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: ask a doctor
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2p.m.
    • wear long-sleeved shirts, pants, hats, and sun-glasses.
  • WARNINGS

    Warnings

    • For external use only
    • Do not use on damaged or broken skin
    • When using this product keep out of eyes. Rinse with water to remove.
    • Stop use and ask a doctor if rash occurs.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    water, alcohol denat., propanediol, glycerin, propylheptyl caprylate, glyceryl stearate, oryza sativa (rice) starch, PEG-100 stearate, benzotriazolyl dodecyl p-cresol, citrus sinensis (orange) peel extract, tocopheryl acetate, glyceryl linoleate, hydrolyzed collagen, bisabolol, citrus nobilis (mandarin orange) oil, citrus aurantium dulcis (orange) oil, glyceryl linolenate, 7-dehydrocholesterol, polyacrylate crosspolymer-11, disodium EDTA, glyceryl polyacrylate, ethylhexylglycerin, tricalcium phosphate, citric acid, phenoxyethanol, fragrance, limonene, linalool, amyl cinnamal, geraniol, yellow 5 (CI 19140), red 4 (CI 14700).

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    MACROANTIOXIDANT SUN PROTECTION 
    avobenzone, homosalate, octinoxate, octocrylene, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63730-340
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)  
    CITRUS SINENSIS FRUIT OIL (UNII: WV48LBL15Q)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERYL LINOLEATE (UNII: 4763AXI84L)  
    GELATIN (UNII: 2G86QN327L)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CITRUS NOBILIS (UNII: 8MFF77J91V)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    GLYCERYL LINOLENATE (UNII: SGB6X4G86K)  
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    GERANIOL (UNII: L837108USY)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63730-340-0130 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/02/2015
    Labeler - Natura Bisse International SA (464431576)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natura Bisse International SA464431576manufacture(63730-340)

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