SURF BAY LIP BALM (LIP BALM) GEL [UNIVERSAL PACKAGING SYSTEMS, INC. DBA: PAKLAB]

SURF BAY LIP BALM (LIP BALM) GEL [UNIVERSAL PACKAGING SYSTEMS, INC. DBA: PAKLAB]
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NDC 61531-100-01
Set ID 2096ffe7-27eb-244f-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Universal Packaging Systems, Inc. DBA: PakLab
Generic Name
Product Class
Product Number
Application Number PART352
  • 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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