Label: MAUI VERA MINERAL SUNSCREEN SPF 30 UNSCENTED- zinc oxide cream

  • NDC Code(s): 81409-003-00, 81409-003-01
  • Packager: Maui Vera, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 31, 2024

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient

    Uncoated Zinc Oxide 20%

    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 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 of 15 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 Barbadensis Leaf Juice, *Morinda Citrifolia (Noni Fruit) Juice, * Arnica montana (Arnica) Extract, *Camellia sinensis (Green Tea), Extract, *Hamamelis virginiana (Witch Hazel) Extract, *MCT Oil, Sorbitane Olivate, Cetearyl Alcohol, Polysorbate 60, Steareth-20, Cetyl Alcohol, *Persea Americana (Avocado) Oil, Panthenol, Lauroyl Lysine, Vitamin E Acetate, Polyhydroxy Stearic Acid, Benzyl Alcohol, Dehydroacetic acid, Xanthan Gum, Sodium Phytate *Organic Ingredients

  • Questions or comments?

    1-415-938-7808

  • Package Labelling:

    Label02.jpg

  • Package Labelling:

    Label03.jpg

  • INGREDIENTS AND APPEARANCE
    MAUI VERA MINERAL SUNSCREEN SPF 30 UNSCENTED 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81409-003
    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)  
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    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:81409-003-0089 mL in 1 TUBE; Type 0: Not a Combination Product05/24/2024
    2NDC:81409-003-01192 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)