Label: BADGER SPF30 UNSCENTED SUNSCREEN UNSCENTED- zinc oxide ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 10, 2011

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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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