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

DRY OIL ANTIOXIDANT SUN PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [NATURA BISSE INTERNATIONAL SA]
PDF | XML

NDC 63730-364-01
Set ID 0bb64b29-b587-450a-a703-9446e9fc618a
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 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)

Related Drugs