FDA.reportPublic FDA data

Mineral Suscreen SPF 30

Product NDC
63750-037
Requested package NDC
63750-037-03
11-digit product format
637500037
Labeler code
63750
Product ID
63750-037_ee8cdf3f-6c70-5053-e053-2a95a90aefb0
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide 19.0%
Dosage form
CREAM
Route
TOPICAL
Labeler
Vivant Pharmaceuticals, LLC
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-01-01
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
22400 mg/118.3mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage63750-03763750-037-03DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63750-037-032024-02-05Vivant Skincare Sunscreen SPF 30
63750-037-042024-02-05Vivant Skincare Sunscreen SPF 30
63750-037-032024-01-30Vivant Skincare Sunscreen SPF 30
63750-037-042024-01-30Vivant Skincare Sunscreen SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63750-037-03Mineral Suscreen SPF 3088.7 mL in 1 BOTTLECREAM88.77
63750-037-04Mineral Suscreen SPF 30118.3 mL in 1 BOTTLECREAM118.37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63750-037MINERAL SUSCREEN SPF 30 (ZINC OXIDE 19.0%) CREAM [VIVANT PHARMACEUTICALS, LLC]6Legacy NDC, 2 package rows20241108_9d25a270-81a3-159d-e053-2a95a90ad240.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63750-037-036375000370388.7 mL in 1 BOTTLE (63750-037-03) 88.7 ml2020-03-010000-00-00NoNoCurrent