ZINKA LEMON TWIST SPF 15 LIP BALM (OXYBENZONE, OCTINOXATE, PETROLATUM) STICK [ZINKA]

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  • ZINKA LEMON TWIST SPF 15 LIP BALM (OXYBENZONE, OCTINOXATE, PETROLATUM) STICK [ZINKA]

ZINKA LEMON TWIST SPF 15 LIP BALM (OXYBENZONE, OCTINOXATE, PETROLATUM) STICK [ZINKA]
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NDC 52993-110-02
Set ID c7e72d26-9723-4b11-97d9-8f5b8f7f1b9b
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 (3.5%)

    Petrolatum (42%)

  • Purpose

    Sunscreen, Sunscreen, Skin Protectant

  • 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, PEG-8, Lanolin, Microcrystalline Wax, Flavor, Paraffin Wax, Copernicia Cerifera (Carnauba) Wax, Sucralose, Aloe Barbadenis Leaf Extract, Tocopherol, Methylparaben, Propylparaben.

  • Package/Label Principal Display Panel

    Zinka Lemon Twist Lip Balm SPF 15
  • INGREDIENTS AND APPEARANCE
    ZINKA LEMON TWIST SPF 15 LIP BALM 
    oxybenzone, octinoxate, petrolatum stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52993-110
    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) OXYBENZONE3.5 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM42 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP) 13.00 mg  in 1 g
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) 3.00 mg  in 1 g
    LANOLIN (UNII: 7EV65EAW6H) 3 mg  in 1 g
    CERESIN (UNII: Q1LS2UJO3A) 17 mg  in 1 g
    PEG-8 STEARATE (UNII: 2P9L47VI5E) 5 mg  in 1 g
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52993-110-021 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(52993-110) , LABEL(52993-110)
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