Label: SURF BAY LIP BALM- lip balm gel

  • 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 September 25, 2015

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  • ACTIVE INGREDIENT

    Octinoxate 7.5%

  • PURPOSE

    Help protect again sunburn and chapped lips

  • KEEP OUT OF REACH OF CHILDREN

    Warnings: Keep out of reach of children

  • INSTRUCTIONS FOR USE

    Apply liberaly 15 minutes before sun exposure

  • INACTIVE INGREDIENT

    Hydrogenated Soybean Oil, Butyrospermum Parkii (Shea) Butter, Beeswax (CERA ALBA), Limnanthes Alba (Meadowfoam) Seed Oil, C10-18 Triglycerides, Hydrogenated Soy Polyglycerides, Flavor (Aroma), Propylene Glycol Myristyl Ether Acetate, Lauryl Lactate, Mentha Piperita (Peppermint) Oil, Salicylic Acid, Tocopheryl Acetate, C15-23 Alkane,

    Sclerocarya Birrea Seed Oil, Triticum Vulgare (Wheat) Germ Oil, Cinnamal, Sucralose, Myristyl Alcohol, Propylene Glycol, Acetic Acid.

  • QUESTIONS

    Questions or Comments? 702-347-1229 or email info@baysoleil.com

  • WARNINGS

    Keep out of reach of children

  • INDICATIONS & USAGE

    Helps protect against sunburn and chapped lips

  • DOSAGE & ADMINISTRATION

    Topical gel

  • Surfbay Display panel jpg

    Surfbay Display panel jpg

  • INGREDIENTS AND APPEARANCE
    SURF BAY LIP BALM 
    lip balm gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61531-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61531-100-0115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/25/2015
    Labeler - Universal Packaging Systems, Inc. DBA: PakLab (790530976)
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