BADGER SPF 34 ANTI-BUG SUNSCREEN (ZINC OXIDE) CREAM [W.S. BADGER COMPANY, INC.]

BADGER SPF 34 ANTI-BUG SUNSCREEN (ZINC OXIDE) CREAM [W.S. BADGER COMPANY, INC.]
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NDC 62206-4730-0
Set ID 70912655-96ac-4823-b911-fc056256842c
Category HUMAN OTC DRUG LABEL
Packager W.S. Badger Company, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • 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/ cm 2 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

    40min

    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

    Label

  • INGREDIENTS AND APPEARANCE
    BADGER SPF 34 ANTI-BUG SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62206-4730
    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:62206-4730-087 mL in 1 TUBE; Type 0: Not a Combination Product11/02/201509/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/02/201503/31/2023
    Labeler - W.S. Badger Company, Inc. (963242326)
    Establishment
    NameAddressID/FEIBusiness Operations
    W.S. Badger Company, Inc.963242326manufacture(62206-4730)

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