Label: SURFERS BARRIER- zinc oxide stick

  • 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 April 18, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Zinc Oxide (non-nano, Uncoated) 24.5%

  • 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, or nuts. Test small area first.

    Keep out of reach of children. lf swallowed, get medical help right away.

  • Directions

    • apply liberally before sun
    • reapply: after 80 min. of swimming or sweating, immediately after towel drying, or as needed
    • children under 6 months: Ask a doctor.
  • Inactive ingredients

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

  • Other information

    • protect package from moisture & extreme heat
  • Questions?

    visit www.avasol.com

  • Principal Display Panel - 1oz Tube Label

    avasol®

    mineral sunscreen

    30 SPF

    Surf & Sport Barrier Water-resistant (80 min.)

    Broad Spectrum (UVA/UVB) People-safe

    • Ocean-safe Authentic
    • 100% Bio-based

    Net Wt 1oz (28 g)

    Principal Display Panel - 1oz Tube Label
  • INGREDIENTS AND APPEARANCE
    SURFERS BARRIER 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58518-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    TAMANU OIL (UNII: JT3LVK84A1)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    THEOBROMA GRANDIFLORUM SEED (UNII: Q7RNT1G37V)  
    SHEANUT (UNII: 84H6HBP32L)  
    MAURITIA FLEXUOSA WHOLE (UNII: 83ULF8L5FI)  
    RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    VANILLA BEAN (UNII: Q74T35078H)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    MICA (UNII: V8A1AW0880)  
    HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
    MANUKA OIL (UNII: M6QU9ZUH2X)  
    ROSEMARY (UNII: IJ67X351P9)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58518-020-0328 g in 1 TUBE; Type 0: Not a Combination Product07/18/2013
    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(58518-020)
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