WINCO ORIGINAL SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [WINCO]

  • Home
  • WINCO ORIGINAL SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [WINCO]

WINCO ORIGINAL SPF 4 LIP BALM (PADIMATE O, PETROLATUM) STICK [WINCO]
PDF | XML
NDC 67091-249-30
Set ID 60a9c437-0513-4196-85d9-e175bb8e4ed6
Category HUMAN OTC DRUG LABEL
Packager Winco
Generic Name
Product Class
Product Number
Application Number PART352
View All Sections
  • Active ingredient

    Padimate O, Petrolatum

  • Purpose

    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 damaged or broken 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.

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

  • Directions

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

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

  • Inactive Ingredients

    Mineral Oil, Ozokerite, Flavor, Microcrystalline Wax, Isopropyl Myristate, Phenyl Trimethicone, Copernicia Cerifera (Carnauba) Wax, Lanolin, Euphorbia Cerifera (Candelilla) Wax, Cetyl Alcohol, Red 6 Lake (CI 15850), Yellow 5 Lake (CI 19140), Methylparaben

  • Package/Label Principal Display Panel

    Winco SPF Original Lip Balm Twin Pack
  • INGREDIENTS AND APPEARANCE
    WINCO ORIGINAL SPF 4 LIP BALM 
    padimate o, petrolatum stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-249
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM44.0 mg  in 1 g
    PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP) 23.50 mg  in 1 g
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) 3.00 mg  in 1 g
    LANOLIN (UNII: 7EV65EAW6H) 1 mg  in 1 g
    CERESIN (UNII: Q1LS2UJO3A) 17.50 mg  in 1 g
    CARNAUBA WAX (UNII: R12CBM0EIZ) 1 mg  in 1 g
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 2.23 mg  in 1 g
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-249-301 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(67091-249) , LABEL(67091-249)
View All Sections

Related Drugs

Search DailyMed Drugs