Label: DRY OIL ANTIOXIDANT SUN PROTECTION- avobenzone, homosalate, octinoxate, octocrylene, oxybenzone cream

  • 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 January 30, 2015

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  • ACTIVE INGREDIENT

    Active Ingredients                                                                 Purpose

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

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

    Octinoxate 4% ...................................................................... Sunscreen

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

    Oxybenzone 5% .................................................................... 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 Dry Oil Antioxidant Sun Protection

    Broad Spectrum SPF 30

    3.5 Fl. Oz. 100 ml

    Made in Spain by 

    Natura Bisse Int. S.A.

    Pque. Tecnol. del Valles

    Cerdanyola - Barcelona

  • 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. - 2 p.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

    alcohol denat., diisopropyl sebacate, benzotriazolyl dodecyl p-cresol, tocopheryl acetate, glyceryl linoleate, vitis vinifera (grape) seed oil, bisabolol, helianthus annuus (sunflower) seed oil, citrus nobilis (mandarin orange) oil, glyceryl linolenate, daucus carotiva sativa (carrot) seed oil, beta-carotene, 7-dehydrocholesterol, ascorbyl palmitate, acrylates/octylacrylamide copolymer, fragrance, limonene, linalool, amyl cinnamal, geraniol, citral.

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    DRY OIL ANTIOXIDANT SUN PROTECTION 
    avobenzone, homosalate, octinoxate, octocrylene, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63730-364
    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) OCTINOXATE4 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERYL LINOLEATE (UNII: 4763AXI84L)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
    CITRUS NOBILIS (UNII: 8MFF77J91V)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    GLYCERYL LINOLENATE (UNII: SGB6X4G86K)  
    DAUCUS CAROTA SUBSP. SATIVUS WHOLE (UNII: F9I9HZH3O3)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    GERANIOL (UNII: L837108USY)  
    CITRAL (UNII: T7EU0O9VPP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63730-364-01100 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/30/2015
    Labeler - Natura Bisse International SA (464431576)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natura Bisse International SA464431576manufacture(63730-364)
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