Label: MAUI VERA MINERAL SUNSCREEN SPF 50 UNSCENTED- zinc oxide cream

  • NDC Code(s): 81409-002-00, 81409-002-01
  • Packager: Maui Vera, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 31, 2024

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  • Drug Facts

  • Active ingredient

    Uncoated Zinc Oxide 23%

    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 bu 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 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 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 value of15 or higher and other sun protection measures including: 
    • 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: Ask a doctor
  • Other information

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

  • Inactive ingredients

    *Aloe Vera Leaf Juice, Caprylic/Capric Triglycerides, Butyloctyl Salicylate, Glycerin, C12-15 Alkyl Benzoate, Polyglyceryl-6 Stearate, Polyglyceryl-6 Behenate, *Avocado Oil, *Shea Butter, Propanediol, Xanthan Gum, Sclerotium Gum, pullulan, phenoxyethanol (and) Ethylhexylglycerin, polyhydroxystearic Acid, Silica, Cetyl Alcohol, *Arnica Extract, *Green Tea Extract, *Noni Fruit Extract   *Organic ingredients

  • Questions or comments?

    1-415-938-7808

  • Package Labeling:

    Label02

  • Package Labelling:

    Label01.jpg

  • INGREDIENTS AND APPEARANCE
    MAUI VERA MINERAL SUNSCREEN SPF 50 UNSCENTED 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81409-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION230 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)  
    POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81409-002-0089 mL in 1 TUBE; Type 0: Not a Combination Product05/24/2024
    2NDC:81409-002-01192 mL in 1 TUBE; Type 0: Not a Combination Product05/24/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/24/2024
    Labeler - Maui Vera, Inc. (019591508)
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