ZINKA LIP PROTECTOR SPF 30 LIP BALM (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) STICK [ZINKA]

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  • ZINKA LIP PROTECTOR SPF 30 LIP BALM (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) STICK [ZINKA]

ZINKA LIP PROTECTOR SPF 30 LIP BALM (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) STICK [ZINKA]
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NDC 52993-125-02
Set ID e35d0ef5-787b-4cec-be5e-0f0c418c42fc
Category HUMAN OTC DRUG LABEL
Packager Zinka
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active ingredient

    Octinoxate (7.5%), Oxybenzone (5.0%), Octisalate (5.0%), Octocrylene (10.0%)

  • 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. Helps prevent and temporarily protects dry, chapped or windburned lips.

  • 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.

  • Directions

    Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

  • Inactive Ingredients

    Ozokerite, Mineral Oil, Petrolatum, Microcrystalline Wax, Ceresin, Flavor, Caprylic/Capric Triglyceride, Copernicia Cerifera (Carnauba) Wax, Titanium Dioxide (CI 77891), Tocopheryl Acetate, Stearic Acid, Aloe Barbadenis Leaf Extract, Aluminum Hydroxide.

  • Package/Label Principal Display Panel

    Zinka Lip Protector SPF 30
  • INGREDIENTS AND APPEARANCE
    ZINKA LIP PROTECTOR SPF 30 LIP BALM 
    octinoxate, octisalate, octocrylene, oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52993-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5.0 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U) 10 mg  in 1 g
    LIGHT MINERAL OIL (UNII: N6K5787QVP) 23.75 mg  in 1 g
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) 4.00 mg  in 1 g
    CERESIN (UNII: Q1LS2UJO3A) 27 mg  in 1 g
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorCOCONUTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52993-125-021 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(52993-125) , LABEL(52993-125)
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