BADGER SPF30 UNSCENTED SUNSCREEN UNSCENTED (ZINC OXIDE) OINTMENT [AUTUMN HARP, INC.]

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BADGER SPF30 UNSCENTED SUNSCREEN UNSCENTED (ZINC OXIDE) OINTMENT [AUTUMN HARP, INC.]
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NDC 51514-201-01
Set ID 21ecd98f-baa2-49c2-b5c0-f22a095ec932
Category HUMAN OTC DRUG LABEL
Packager Autumn Harp, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active Ungredient

    Non-Nano Uncoated Zinc Oxide 18.75%

  • Purpose

    Sunscreen

  • Uses:

    • Helps prevent sunburn
    • Reatins SPF after 40 minutes of activity in the water or perspiring
    • Higher SPF gives more sunburn protection
  • Warnings:

    For external use only

  • When using this product

    Keep out of eyes. Rinse with water to remove

  • Stop use and ask a doctor if

    Rash pr irritation develops and lasts

  • Directions:

    • For full protection, apply ample white coat to all exposed skin, then rub to reduce the whitening effect.
    • Some separation may occur. Knead tube before use.
    • Reapply after swimming and sweating as needed.
    • For children under 6 months of age: ask a doctor
  • PRINCIPAL DISPLAY PANEL

    Image of Tube Label

  • INGREDIENTS AND APPEARANCE
    BADGER SPF30 UNSCENTED SUNSCREEN  UNSCENTED
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide18.75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-201-0187 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/10/2011
    Labeler - Autumn Harp, Inc. (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc.064187883manufacture
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