FDA.reportPublic FDA data

Maui Vera Reef Friendly Mineral Sunscreen

Manufacturer
Maui Vera, Inc.
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:04:09

Label at a glance#

ProductMaui Vera Reef Friendly Mineral Sunscreen
Active ingredientZINC OXIDE
Label structure9 sections

Indications and 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. D irections

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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 ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

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 Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

*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?

OTC - QUESTIONS SECTION

1-415-938-7808

Package Labeling: 89ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling: 192ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81409-001-012026-01-29C16284748780-149896155-ac58-586f-e063-e6dba90add90Maui Vera Reef Friendly Mineral Sunscreen
81409-001-022026-01-29C16284748780-149896155-ac58-586f-e063-e6dba90add90Maui Vera Reef Friendly Mineral Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81409-001-01Maui Vera Reef Friendly Mineral Sunscreen89 mL in 1 TUBELOTION892
81409-001-02Maui Vera Reef Friendly Mineral Sunscreen192 mL in 1 TUBELOTION1922

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81409-001MAUI VERA REEF FRIENDLY MINERAL SUNSCREEN (ZINC OXIDE) LOTION [MAUI VERA, INC.]2Legacy NDC, 2 package rows20231213_ec120bdd-41a8-4e6a-8094-8a5311d99683.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81409-00181409-001-01, 81409-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
AVOCADOSDS87L369FIACT
PANTHENOLWV9CM0O67ZIACT
LAUROYL LYSINE113171Q70BIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BENZYL ALCOHOLLKG8494WBHIACT
DEHYDROACETIC ACID2KAG279R6RIACT
XANTHAN GUMTTV12P4NEEIACT
PHYTATE SODIUM88496G1ERLIACT
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
08aab616-178b-b096-e063-6394a90a2f88ec120bdd-41a8-4e6a-8094-8a5311d996832023-10-26WarningsExact identifier
spl id: 08aab616-178b-b096-e063-6394a90a2f88
spl set id: ec120bdd-41a8-4e6a-8094-8a5311d99683

Reported adverse events (FAERS/openFDA)#

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