Label: PRO FORMULA- zinc oxide, titanium dioxide stick

  • NDC Code(s): 58518-030-03, 58518-030-04
  • Packager: Avasol LLC
  • 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 24, 2023

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  • Active Ingredients

    Zinc Oxide (non-nano, Uncoated) 24.5%

    Titanium Dioxide (non-nano, Uncoated) 6%

  • Purpose

    Sunscreen

    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. If 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

    *Caprylic/Capric Triglyceride (Coconut), *Cocos Nucifera (Coconut) Oil,*Helianthus annuus (Sunflower) Oil, **Euphorbia cerifera (Candelilla) wax, *Calophyllum Inophyllum (Tamanu)Oil,*Beeswax,**Theobroma Grandiflorum (Cupuacu) Seed Butter, Mica, Tocopherol (Vitamin E),*Aloe Vera Leaf, Iron oxides, *Propolis, *Rosmarinus Officinalis (Rosemary) Leaf Extract, **Leptospermum scoparium (Manuka) Oil,*Cinnamomum Zeylanicum(Cinnamon) Bark Oil.

    *Organic **Wildcrafted

  • Other information

    • protect package from moisture & extreme heat.
  • Questions?

    visit www.avasol.com

  • Principal Display Panel - 28 g Tube Label

    avasol®

    mineral sunscreen
    PRO 50+SPF

    Net Wt 1 oz (28 g)

    Pro-Grade Skin Barrier

    Water-resistant (80 min.)

    Broad Spectrum (UVA/UVB)

    Safer for People & the Ocean

    USDA Certified 100% Biobased

    Principal Display Panel - 28 g Tube Label
  • INGREDIENTS AND APPEARANCE
    PRO FORMULA 
    zinc oxide, titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58518-030
    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
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    TAMANU OIL (UNII: JT3LVK84A1)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    THEOBROMA GRANDIFLORUM SEED (UNII: Q7RNT1G37V)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MANUKA OIL (UNII: M6QU9ZUH2X)  
    ROSEMARY (UNII: IJ67X351P9)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58518-030-0328 g in 1 TUBE; Type 0: Not a Combination Product05/01/2023
    2NDC:58518-030-04224 g in 1 POUCH; Type 0: Not a Combination Product05/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2023
    Labeler - Avasol LLC (078822898)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avasol LLC078822898MANUFACTURE(58518-030)
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