Label: BADGER SPF 34 ANTI-BUG SUNSCREEN- zinc oxide cream

  • 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 January 13, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Sunscreen Ingredient

    Non-Nano Uncoated Zinc Oxide 20%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Caution

    For external use only

    Do not use on damaged or broken skin. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. Stop and ask a doctor if rash occurs.

    When using this product keep out of eyes. Rinse with water to remove.

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

    • Adult supervision required.
    • Do not apply to children's hands.
  • Directions

    • For full protection, apply liberally (2mg/cm2 of skin) to all exposed skin 15 minutes before sun exposure, then rub in to reduce whitening effect.

    Reapply

    • After 40 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours

    Sun Protection Measures

    • Spending time in the sun increases your risk of skin cancer and early skin aging
    • To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10am-2pm
      • Wear long-sleeved shirts, pants, hats, and sunglasses
    • For children under 6 months of age: ask a doctor.
  • Ingredients

    1Olea Europaea (Extra Virgin Olive) Oil, 1Cera Alba (Beeswax), 1Ricinus Communis (Castor) Oil, 1Cymbopogon Nardus (Citronella) Oil, 1Cymbopogon Schoenanthus (Lemongrass) Oil, 1Cedrus Deodara (Cedar) Oil,1Rosmarinus Officinalis (Rosemary) Oil, and 1Pelargonium Graveolens (Geranium) Oil.

    1
    =Certified Organic
  • PRINCIPAL DISPLAY PANEL - 87 ml Tube Label

    Active

    BADGER®

    DEET
    FREE

    Citronella & Cedar

    Broad Spectrum
    SPF 34

    ANTI-BUG
    SUNSCREEN

    Tested to Repel Mosquitoes
    Certified Natural • Contains 98% Organic Ingredients

    WATER
    RESISTANT
    40 min

    UVA
    UVB

    NON
    NANO

    BIO
    DEGRADABLE

    ACTIVE ANTI-BUG INGREDIENTS (15.5%): 10% *Castor Oil,
    & Essential Oils of 2.5% *Citronella, 1.25% *Lemongrass,
    1% *Cedar, 0.5% *Rosemary, & 0.25% *Geranium.

    OTHER INGREDIENTS (84.5%): *Extra Virgin Olive Oil,
    Zinc Oxide, *Beeswax. *= Certified Organic

    87ml/2.9 fl.oz

    PRINCIPAL DISPLAY PANEL - 87 ml Tube Label
  • INGREDIENTS AND APPEARANCE
    BADGER SPF 34 ANTI-BUG SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55143-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    CEDRUS DEODARA WOOD (UNII: 1GO876QOY2)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55143-103-0187 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35201/01/2014
    Labeler - Norwood Packaging Ltd. (243693926)
    Establishment
    NameAddressID/FEIBusiness Operations
    Norwood Packaging Ltd.243693926MANUFACTURE(55143-103)
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