Label: LIP BALM SUNSCREEN SPF 4 ORIGINAL- padimate o stick

  • NDC Code(s): 0363-6050-01, 0363-6050-02
  • Packager: Walgreen Co
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

If you are a consumer or patient please visit this version.

  • Active ingredients

    Padimate O, 1.5%

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  • Purpose

    Sunscreen

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  • Uses

    • Helps prevent sunburn
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  • 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 help prevent sunburn, not skin cancer or early skin aging.

    For external use only

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  • DO NOT USE

    Do not use on damaged or broken skin

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  • WHEN USING

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

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  • STOP USE

    Stop use and ask a doctor if rash occurs. Close
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away. Close
  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water-resistant sunscreen if swimming or sweating
    • children under 6 months of age: Ask a doctor
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  • Other information

    • protect this product from excessive heat and direct sunlight
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  • Inactive ingredients

    Petrolatum, paraffinum liquidum (mineral oil), ozokerite, octyldodecanol, phenyl methicone, flavor, arachidyl propionate, cera alba (beeswax), camphor, copernicia cerifera (carnauba) wax, isopropyl lanolate, isopropyl myristate, lanolin, paraffin, cetyl alcohol, saccharin, methylparaben, propylparaben, D&C red #6 (CI 15850), FD&C yellow #5 (CI 19140)

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  • INGREDIENTS AND APPEARANCE
    LIP BALM SUNSCREEN SPF 4  ORIGINAL
    spf4 lip balm stick
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-6050
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PADIMATE O (PADIMATE O) PADIMATE O 1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM  
    ARACHIDYL PROPIONATE  
    WHITE WAX  
    CAMPHOR (NATURAL)  
    CARNAUBA WAX  
    CETYL ALCOHOL  
    D&C RED NO. 6  
    FD&C YELLOW NO. 5  
    ISOPROPYL MYRISTATE  
    LIGHT MINERAL OIL  
    METHYLPARABEN  
    OCTYLDODECANOL  
    PARAFFIN  
    PROPYLPARABEN  
    SACCHARIN  
    LANOLIN  
    PHENYL TRIMETHICONE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-6050-02 2 in 1 BLISTER PACK
    1 NDC:0363-6050-01 4 g in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 09/01/2013
    Labeler - Walgreen Co (008965063)
    Registrant - Lee Pharmaceuticals (056425432)
    Establishment
    Name Address ID/FEI Business Operations
    Lee Pharmaceuticals 056425432 manufacture(0363-6050)
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