Label: SALT AND STONE OUTDOOR VOICES SPF 50- zinc oxide stick

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

Drug Label Information

Updated October 28, 2023

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  • DRUG FACTS

  • Active Ingredients

    Zinc Oxide (Non-Nano) 24%

    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.

    When using this product,

    keep out of eyes. Rinse with water to remove.

    If rash occurs, 

    stop use and see a doctor.

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a poison control center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply:
    • After 80 minutes of swimming or sweating,
    • Immediately after towel drying,
    • At least every two (2) hours.
    • Sun Protection Measures Spenidng time in the sun increases the risk of skin cancer and early skin aging. To decrease the risk, regularly use: a sunscreen with a broad-spectrum SPF of 15 or higher, and sun protection measures including:
    • Limiting time in the sun, especially from 10AM - 2PM.
    • Wear long-sleeved shirts, pants, hats, and sunglasses.

    Children undre 6 months: Ask a doctor.

  • Other Information

    Protect this product from excess heat and direct sun.

  • Inactive Ingredients

    Butyloctyl Salicylate, Cera Alba*, Cocos Nucifera (Coconut) Oil*, Copernicia Cerifera (Carnauba) Wax*, Curcuma Longa (Turmeric) Root Extract, Ethylhexyl Methoxycrylene, Helianthus Annuus (Sun flower) Seed Oil*, Iron Oxides, Mica, Silica Simmondsia Chinensis (Jojoba) Seed Oil*, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethoxycaprylylsilane, Vegetable Oil*. *Organic Ingredient

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SALT AND STONE OUTDOOR VOICES SPF 50 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71585-143
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION240 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CORN OIL (UNII: 8470G57WFM)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    JOJOBA OIL (UNII: 724GKU717M)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TURMERIC (UNII: 856YO1Z64F)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71585-143-0015 g in 1 TUBE; Type 0: Not a Combination Product04/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/01/2023
    Labeler - Salt & Stone, Inc. (080683697)
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