WINCO MOISTURE SPF 15 LIP BALM (OXYBENZONE, OCTINOXATE, PETROLATUM) STICK [WINCO]

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  • WINCO MOISTURE SPF 15 LIP BALM (OXYBENZONE, OCTINOXATE, PETROLATUM) STICK [WINCO]

WINCO MOISTURE SPF 15 LIP BALM (OXYBENZONE, OCTINOXATE, PETROLATUM) STICK [WINCO]
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NDC 67091-250-30
Set ID 6dd76e6a-42b2-4539-abfe-fa600db693ca
Category HUMAN OTC DRUG LABEL
Packager Winco
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active ingredient

    Octinoxate (7.5%), Oxybenzone (3.5%)

    Petrolatum (40.7%)

  • 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

    Do not use on broken or damaged skin

    Stop use and ask a doctor: If rash or irritation develops and lasts for more than 7 days.

    When using this product keep out of eyes. Rinse with water to remove.

  • Directions

    Apply liberally 15 minutes before sun exposure. Reapply as needed.

    Children under 6 months of age: Ask a doctor before use.

  • Inactive Ingredients

    Ozokerite, Mineral Oil, Isocetyl Stearate, Microcrystalline Wax, Isopropyl Lanolate, Lanolin, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Isopropyl Myristate, Aloe Barbadenis Leaf Extract, Paraffin, Cetyl Alcohol, Tocerpheryl Linoleate, Flavor, Methylparaben, Propylparaben.

  • Package/Label Principal Display Panel

    Winco SPF 15 Moisturizer Lip Balm Twin Pack
  • INGREDIENTS AND APPEARANCE
    WINCO MOISTURE SPF 15 LIP BALM 
    oxybenzone, octinoxate, petrolatum stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-250
    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) PETROLATUM40.7 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CERESIN (UNII: Q1LS2UJO3A) 17.13 mg  in 1 g
    LIGHT MINERAL OIL (UNII: N6K5787QVP) 16.75 mg  in 1 g
    ISOCETYL STEARATE (UNII: 3RJ7186O9W) 3.50 mg  in 1 g
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) 3.00 mg  in 1 g
    LANOLIN (UNII: 7EV65EAW6H) 1 mg  in 1 g
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .60 mg  in 1 g
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-250-301 g in 1 CONTAINER; Type 0: Not a Combination Product01/02/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/02/2015
    Labeler - Winco (056098817)
    Registrant - OraLabs (801824756)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(67091-250) , LABEL(67091-250)
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