Label: CHEMICAL FREE SUNSCREEN- zinc oxide lotion

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

Drug Label Information

Updated December 21, 2023

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  • ​Drug Facts

  • ​Active Ingredient

    Zinc Oxide 14.57%

    ​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.

    Stop use and ask a doctor

    if rash occurs.

    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 40 minutes of swimming or sweating.
    •  immediately after towel drying.
    •  at least every 2 hours.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limited time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats and sunglasses.
    • Children under 6 months: ask a doctor.
  • ​Inactive Ingredients:

    Organic High Oleic Sunflower Oil, Organic Coconut Oil, Beeswax, Organic Shea Butter, Tocopherols, Fragrance (All Natural), Carrot Seed Oil.

  • ​Other Information

    • Protect this product from excessive heat and direct sun.
  • Package Labeling

    Label

  • INGREDIENTS AND APPEARANCE
    CHEMICAL FREE SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72209-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION145.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARROT SEED OIL (UNII: 595AO13F11)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72209-001-04118 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/2019
    Labeler - Herban Roots, LLC (040718836)
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