Label: MAUI VERA REEF FRIENDLY MINERAL SUNSCREEN- zinc oxide lotion

  • NDC Code(s): 81409-001-01, 81409-001-02
  • Packager: Maui Vera, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 26, 2023

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  • Drug Facts

  • Active ingredient

    Zinc Oxide 20%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
  • 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 swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply at least every2 hours
    • Use a water resistant sunscreen if swimming or sweating 
    • 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 value of 15 or higher and other sun protection measures including: Sun Protection Measures.
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses.
    • Children under 6 months of age: Ask a doctor
  • Other information

    Protect the product and this container from excessive heat and direct sun.

  • Inactive ingredients

    *Aloe Barbadensis Leaf (Aloe) Juice, *Caprylic/Capric Triglyceride, (Coconut Oil),Cetearyl Olivate, Sorbitane Olivate, Cetearyl Alcohol, Cetyl Alcohol, *Persea Americana (Avocado) Oil, Panthenol (Vitamin B-5), Lauroyl Lysin, Vitamin E Acetate, Polyhydroxy Stearic Acid, Benzyl Alcohol, Dehydroacetic Acid, Xanthan Gum, Sodium Phytate *Organic Ingredients

  • Questions or comments?

    1-415-938-7808

  • Package Labeling: 89ml

    Label

  • Package Labeling: 192ml

    Label2

  • INGREDIENTS AND APPEARANCE
    MAUI VERA REEF FRIENDLY MINERAL SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81409-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    AVOCADO (UNII: SDS87L369F)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81409-001-0189 mL in 1 TUBE; Type 0: Not a Combination Product09/01/2021
    2NDC:81409-001-02192 mL in 1 TUBE; Type 0: Not a Combination Product09/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/01/2021
    Labeler - Maui Vera, Inc. (019591508)
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