Label: ENVIRONMENTAL DEFENSE- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 15, 2023

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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 DrugM02007/18/2013
    Labeler - Avasol LLC (078822898)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avasol LLC078822898manufacture(58518-010)
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