DAILY DEFENCE SUNSCREEN BROAD SPECTRUM SPF30 (OCTINOXATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [ZELENS LIMITED]

DAILY DEFENCE SUNSCREEN BROAD SPECTRUM SPF30 (OCTINOXATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [ZELENS LIMITED]
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NDC 63712-123-01
Set ID 373d835c-762a-485b-8489-8a596234fb7b
Category HUMAN OTC DRUG LABEL
Packager ZELENS Limited
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone 3%Sunscreen
    Octionoxate 7.4%Sunscreen
    Octisalate 5%Sunscreen
    Octocrylene 2.7%Sunscreen
  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • 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

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

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:
      • after 40 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours

      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 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-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • Other information

    • protect this product from excessive heat and direct sun
    • you may report a serious adverse reaction to this product to: Report Reaction, LLC PO Box 22 Plainsboro, NJ 08536-0222
  • Inactive ingredients

    Water, Cyclohexasiloxane, Glycerin, Butylene Glycol, Butyloctyl Salicylate, Isononyl Isononanoate, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Micrococcus Lysate, Perilla Frutescens Leaf Extract, Sodium Hylauronate, Glutamylamidoethyl Imidazole, Ascorbyl Tetraisopalmitate, Tocopheryl Acetate, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Echinacea Angustifolia Leaf Extract, Ginkgo Biloba Leaf Extract, Pinus Strobus Bark Extract, Lecithin, Silica, Hydrogenated Palm Glycerides, Cyclopentasiloxane, PVP, Potassium Cetyl Phosphate, Sorbitol, Ceteareth-20, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Polyacrylate, Fragrance, Linalool, Sorbic Acid, Chlorphenesin, Phenoxyethanol, BHT, Sodium Hydroxide, Disodium EDTA

  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Box

    zelens
    dr marko lens

    Daily Defence

    SUNSCREEN
    BROAD SPECTRUM SPF 30

    High Protection

    50 mL / 1.7 Fl.Oz.

    Principal Display Panel - 50 mL Tube Box
  • INGREDIENTS AND APPEARANCE
    DAILY DEFENCE SUNSCREEN BROAD SPECTRUM SPF30 
    octinoxate, octisalate, avobenzone, and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63712-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE74 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)  
    GINKGO (UNII: 19FUJ2C58T)  
    PINUS STROBUS BARK (UNII: 8PJ4761097)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    SORBITOL (UNII: 506T60A25R)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    SORBIC ACID (UNII: X045WJ989B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63712-123-011 in 1 BOX06/02/2014
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/02/2014
    Labeler - ZELENS Limited (217149018)
    Establishment
    NameAddressID/FEIBusiness Operations
    Originitalia441072253manufacture(63712-123)

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