Label: ENVIRONMENTAL DEFENSE- 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 December 15, 2021

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  • Active Ingredients

    Zinc Oxide (Non-nano) 22.5%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • Warnings

    • For external use only
    • Keep out of eyes. Rinse with water to remove

    Stop use and ask a doctor if rash or irritation occurs.

    Do not use if allergic to ingredients.

    • Test small area first.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally before sun
    • Reapply: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours, or as needed
    • Children under 6 months: Ask a doctor
    • May stain some fabrics.
  • Inactive ingredients

    Caprylic/Capric Triglyceride (Coconut), *Simmondsia Chinensis (Jojoba) Seed Oil,*Helianthus annuus (Sun flower) Oil,*Cocos Nucifera (Coconut) Oil,*Calophyllum Inophyllum (Tamanu)Oil,*Argania spinosa (Argan) Oil, Silica, *Beeswax,*Theobroma Grandiflorum (Cupuacu) Seed Butter,*Butyrospermum parkii (Shea Butter),**Mauritia Flexuosa (Buriti) Fruit Oil, Rubus idaeus (Raspberry) Seed Oil, Tocopherol (Vitamin E), Mica, Iron oxides, *Vanilla Planifolia(Vanilla) Fruit Extract, Plankton Extract,*Propolis,*Rosmarinus Officinalis (Rosemary) Leaf Extract,**Leptospermum scoparium (Manuka)Oil, *Cinnamomum Zeylanicum (Cinnamon) Bark Oil, Love. *Organic **Wildcrafted

  • Other information

    Shake well before use. Warm as needed.

  • Questions?

    Call 888-805-1507or visit www.avasol.com

  • Principal Display Panel - 2 Fl Oz Bottle Label

    avasol®

    mineral sunscreen

    30 SPF

    2 FL OZ (59 mL)

    Principal Display Panel - 2 Fl Oz Bottle Label
  • INGREDIENTS AND APPEARANCE
    ENVIRONMENTAL DEFENSE 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58518-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE225 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TAMANU OIL (UNII: JT3LVK84A1)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    THEOBROMA GRANDIFLORUM SEED (UNII: Q7RNT1G37V)  
    SHEANUT (UNII: 84H6HBP32L)  
    MAURITIA FLEXUOSA WHOLE (UNII: 83ULF8L5FI)  
    RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    VANILLA BEAN (UNII: Q74T35078H)  
    MICA (UNII: V8A1AW0880)  
    HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    MANUKA OIL (UNII: M6QU9ZUH2X)  
    ROSEMARY (UNII: IJ67X351P9)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58518-010-0260 mL in 1 POUCH; Type 0: Not a Combination Product11/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/18/2013
    Labeler - Avasol LLC (078822898)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avasol LLC078822898MANUFACTURE(58518-010)
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