FDA.reportPublic FDA data

Maui Vera Mineral Sunscreen SPF 30 Unscented

Manufacturer
Maui Vera, Inc.
Effective date
2024-11-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:39:33

Label at a glance#

ProductMaui Vera Mineral Sunscreen SPF 30 Unscented
Active ingredientZINC OXIDE
Label structure9 sections

Indications and 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.

Dosage and administration

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 th...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Uncoated Zinc Oxide 20%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

*Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglycerides, Butyloctyl Salicylate, Glycerin, C12-15 Alkyl Benzoate, Polyglyceryl-6 Stearate, Polyglyceryl-6 Behenate, *Persea Gratissima (Avocado) Oil, Butyrospermum Parkii (Shea) Butter, Propanediol, Xanthan Gum, Sclerotium Gum, Pullulan, Dehydroacetic Acid (and) Benzyl Alcohol, Polyhydroxystearic Acid, Silica, Cetyl Alcohol, *Arnica montana (Arnica) Extract, *Camellia sinensis (Green Tea) Extract, *Morinda Citrifolia (Noni Fruit), *Citrus Aurantium Bergamia (Bergamot) Fruit Oil *Organic Ingredints

Questions or comments?

OTC - QUESTIONS SECTION

1-415-938-7808

Package Labeling:89ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label03Label03

Package Labeling:192ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label04Label04

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81409-003-00Maui Vera Mineral Sunscreen SPF 30 Unscented89 mL in 1 TUBECREAM893
81409-003-01Maui Vera Mineral Sunscreen SPF 30 Unscented192 mL in 1 TUBECREAM1923

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81409-003MAUI VERA MINERAL SUNSCREEN SPF 30 UNSCENTED (ZINC OXIDE) CREAM [MAUI VERA, INC.]32 package rows20241127_fff96669-4157-4517-906e-a9be0b44be1f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81409-00381409-003-00, 81409-003-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
POLYGLYCERYL-6 STEARATEETY9Q81E2TIACT
POLYGLYCERYL-6 BEHENATE4T2L7QI313IACT
AVOCADO OIL6VNO72PFC1IACT
SHEA BUTTERK49155WL9YIACT
PROPANEDIOL5965N8W85TIACT
XANTHAN GUMTTV12P4NEEIACT
SCLEROTIUM GUM2X51AD1X3TIACT
PULLULAN8ZQ0AYU1TTIACT
DEHYDROACETIC ACID2KAG279R6RIACT
BENZYL ALCOHOLLKG8494WBHIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CETYL ALCOHOL936JST6JCNIACT
ARNICA MONTANA WHOLEO80TY208ZWIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
NONI FRUIT7829X3G2X5IACT
BERGAMOT OIL39W1PKE3JIIACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
27be1b51-9a08-6786-e063-6394a90aff8efff96669-4157-4517-906e-a9be0b44be1f2024-11-25WarningsExact identifier
spl id: 27be1b51-9a08-6786-e063-6394a90aff8e
spl set id: fff96669-4157-4517-906e-a9be0b44be1f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.