Label: BLISTEX MEDICATED BERRY BALM- dimethicone, padimate o, and oxybenzone 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 March 13, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Dimethicone 2.0% (w/w)Lip protectant
    Oxybenzone 2.5% (w/w)Sunscreen
    Padimate O 6.6% (w/w)Sunscreen
  • Uses

    • temporarily protects and helps relieve chapped or cracked lips
    • 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 on damaged or broken skin

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

    Stop use and ask a doctor if rash occurs

    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
  • Inactive ingredients

    beeswax, camphor, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavor, isopropyl myristate, isopropyl palmitate, isopropyl stearate, lanolin, lanolin oil, menthol, methylparaben, mineral oil, ozokerite, paraffin, petrolatum, polybutene, propylparaben, red 6 lake, theobroma cacao (cocoa) seed butter, titanium dioxide

  • Other information

    • protect the product in this container from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton

    Blistex® MEDICATED BERRY BALM

    NET WT. .15 oz (4.25g)

    SPF 15

    Principal Display Panel - 4.25 g Cylinder Carton
  • INGREDIENTS AND APPEARANCE
    BLISTEX   MEDICATED BERRY BALM
    dimethicone, padimate o, and oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9713
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
    Padimate O (UNII: Z11006CMUZ) (Padimate O - UNII:Z11006CMUZ) Padimate O6.6 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ISOPROPYL STEARATE (UNII: 43253ZW1MZ)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LANOLIN OIL (UNII: OVV5IIJ58F)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINKScore    
    ShapeBULLETSize
    FlavorRASPBERRY (fruity) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-9713-33 in 1 CARTON
    1NDC:10157-9713-14.25 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/01/2010
    Labeler - Blistex Inc (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc005126354MANUFACTURE(10157-9713)
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