Label: ALBA BOTANICA UN-PETROLEUM CHERRY SPF18 LIP BALM- ethylhexyl dimethyl paba, benzophenone-3 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 May 7, 2012

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  • ACTIVE INGREDIENT

    Ethylhexyl Dimethyl PABA       7.5%

    Benzophenone-3      5.0%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps prevent sunburn

  • WARNINGS

    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 skin rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Children under 6 mos ask a doctor.

    Skin Protection Measures:Spending time in the sun increases your risk of skin cancer and early skin aging.

  • INACTIVE INGREDIENT

    Ricinus Communis (Castor) Seed Oil, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Simmondsia Chinensis (Jojoba) Seed Oil (1), Lanolin, Flavor, Copernicia Cerifera (Carnauba) Wax, Glycine Soja (Soybean) Oil, Oenothera Biennis (Evening Primrose) Oil, Olea Europaea (0live)Fruit Oil, Echinacea Purpurea Extract, Ammonium Glycyrrhizate, Tocopherol, Tocopheryl Acetate, Cinnamal, Eugenol.



    (1) Certified Organic Ingredient

  • QUESTIONS

    Questions? Call 888-659-7730 or visit www.AlbaBotanica.com

  • PRINCIPAL DISPLAY PANEL

      image of container label      image of carton label

  • INGREDIENTS AND APPEARANCE
    ALBA BOTANICA UN-PETROLEUM CHERRY SPF18 LIP BALM 
    ethylhexyl dimethyl paba, benzophenone-3 stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2923
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    JOJOBA OIL (UNII: 724GKU717M)  
    LANOLIN (UNII: 7EV65EAW6H)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ECHINACEA PURPUREA (UNII: QI7G114Y98)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    EUGENOL (UNII: 3T8H1794QW)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-2923-11 in 1 CARTON
    14.2 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/02/2011
    Labeler - The Hain Celestial Group, Inc. (858894996)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.858894996manufacture
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