Label: BADGER ACTIVE SPF 30 CLEAR ZINC SUNSCREEN- zinc oxide cream

  • NDC Code(s): 62206-4710-0
  • Packager: W.S. Badger Company, Inc.
  • 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 September 29, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Uncoated Zinc Oxide 18.75%

  • 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.
  • Warnings

    For external use only

    Do not use on damaged or broken skin. 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 product is swallowed, get medical help or contact a Poison Control Center right away.

  • 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 80 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 a 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

    1Helianthus Annuus ( Sunflower) Oil, 1Cera Alba ( Beeswax), Tocopherol ( Sunflower Vitamin E), * Hippophae rhamnoides (Sea Buckthorn) Fruit Extract.

    1
    = Organic
  • Other Information

    Store at temperatures below 90°F.

  • PRINCIPAL DISPLAY PANEL - 87 ml Tube Label

    Active

    BADGER     ®

    Unscented

    Broad Spectrum
    SPF 30

    CLEAR ZINC

    NATURAL MINERAL
    SUNSCREEN CREAM

    Non-Whitening

    Face & Body

    WATER RESISTANT 40min

    NON GMO

    CLEAR ZINC

    REEF FRIENDLY


    98% ORGANIC INGREDIENTS

    & CLEAR ZINC OXIDE

    87ml/2.9 fl.oz

    Label

  • INGREDIENTS AND APPEARANCE
    BADGER ACTIVE SPF 30 CLEAR ZINC SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62206-4710
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE18.75 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62206-4710-087 mL in 1 TUBE; Type 0: Not a Combination Product02/10/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/10/2018
    Labeler - W.S. Badger Company, Inc. (963242326)
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