Maui Vera Reef Friendly Mineral Sunscreen

Product NDC
81409-001
Requested package NDC
81409-001-01
11-digit product format
814090001
Labeler code
81409
Product ID
81409-001_cba904a6-e8b4-6c89-e053-2995a90a403f
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Maui Vera, Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-09-01
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
200 mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage81409-00181409-001-01IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81409-001-018140900010189 mL in 1 TUBE (81409-001-01) 89 ml2021-09-010000-00-00NoNoCurrent