Label: LIP BALM SUNSCREEN SPF 4 ORIGINAL- spf4 lip balm stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 15, 2013

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  • Active ingredients

    Padimate O, 1.5%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • 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

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if rash occurs.
  • 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.
  • 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
  • Other information

    • protect this product from excessive heat and direct sunlight
  • 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)

  • PRINCIPAL DISPLAY PANEL

    Label

  • PRINCIPAL DISPLAY PANEL

    Card

  • INGREDIENTS AND APPEARANCE
    LIP BALM SUNSCREEN SPF 4  ORIGINAL
    spf4 lip balm stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SACCHARIN (UNII: FST467XS7D)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6050-022 in 1 BLISTER PACK
    1NDC:0363-6050-014 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/01/2013
    Labeler - Walgreen Co (008965063)
    Registrant - Lee Pharmaceuticals (056425432)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lee Pharmaceuticals056425432manufacture(0363-6050)
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