Label: LEADER ORIGINAL SPF 4 LIP BALM- padimate o, petrolatum stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 21, 2014

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  • 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

    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

    Mineral Oil, Ozokerite, Microcrystalline Wax, Phenyl Trimethicone, Lanolin, Copercicia (Carnauba) Wax, Isopropyl Myristate, Cetyl Alcohol, Euphorbia Cerifera (Candelilla) Wax, Flavor, Camphor, Methylparaben, Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Red 6 Lake (CI 15850).

  • Package/Label Principal Display Panel

    Leader Original SPF Lip Balm.jpg
  • INGREDIENTS AND APPEARANCE
    LEADER ORIGINAL SPF 4 LIP BALM 
    padimate o, petrolatum stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-694
    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
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) 3.00 mg  in 1 g
    LANOLIN (UNII: 7EV65EAW6H) 1 mg  in 1 g
    CERESIN (UNII: Q1LS2UJO3A) 17.30 mg  in 1 g
    CARNAUBA WAX (UNII: R12CBM0EIZ) 1 mg  in 1 g
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 2.23 mg  in 1 g
    LIGHT MINERAL OIL (UNII: N6K5787QVP) 27.50 mg  in 1 g
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-694-031 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/15/2013
    Labeler - Cardinal Health (Leader) (097537435)
    Registrant - Cardinal Health (Leader) (097537435)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(37205-694) , LABEL(37205-694)
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