ZINKA SPF 50 FACESTICK (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE) STICK [ZINKA]

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  • ZINKA SPF 50 FACESTICK (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE) STICK [ZINKA]

ZINKA SPF 50 FACESTICK (HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE) STICK [ZINKA]
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NDC 52993-150-03
Set ID 94e23afd-05ca-4f6b-82af-0bccf702f198
Category HUMAN OTC DRUG LABEL
Packager Zinka
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active ingredient

    Homosalate (6.9%), Octinoxate (4.7%), Octisalate (4.0%), Octocrylene (3.4%), Zinc Oxide (5.0%)

  • Purpose

    Sunscreen

  • Keep Out of Reach of Children

    If swallowed get medical help or contact a Poison Control Center right away.

  • Uses

    Helps prevent sunburn.

  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.

    For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts. Keep out of eyes. Rinse with water to remove.

  • Directions

    Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours.

  • Inactive Ingredients

    BHT, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Cetyl Alcohol, Flavor Methylparaben, Microcrystalline Wax, Ozokerite, Polyethylene, Propylparaben, PVP/Hexadecene Copolymer, Synthetic Beeswax, Tapioca Starch Polymethylsilsesquioxane, Tocopherol,.

  • Package/Label Principal Display Panel

    Zinka Back Label SPF 50+ Facestick
  • INGREDIENTS AND APPEARANCE
    ZINKA SPF 50 FACESTICK 
    homosalate, octinoxate, octisalate, octocrylene, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52993-150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4.7 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6.90 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.40 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) 10.50 mg  in 1 g
    CERESIN (UNII: Q1LS2UJO3A) 10.30 mg  in 1 g
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 15.5 mg  in 1 g
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) 13 mg  in 1 g
    WHITE WAX (UNII: 7G1J5DA97F) 6.3 mg  in 1 g
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52993-150-031 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/09/2014
    Labeler - Zinka (153569595)
    Registrant - Zinka (153569595)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(52993-150) , LABEL(52993-150)
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