FDA.reportPublic FDA data

suncare essentials

Product NDC
59062-5100
Requested package NDC
59062-5100-1
11-digit product format
590625100
Labeler code
59062
Product ID
59062-5100_bb3ca7dd-8b3d-4ef1-9dd8-caa1bbd20d8a
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Octisalate, and Zinc Oxide
Dosage form
KIT
Labeler
KAS Direct LLC dba BabyGanics
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-01-01
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage59062-510059062-5100-1DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-5100SUNCARE ESSENTIALS (TITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDE) KIT [KAS DIRECT LLC DBA BABYGANICS]2Legacy NDC20250104_96fd2cf8-cb07-4ec1-8946-8e862f6d8377.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59062-5100-1590625100011 KIT in 1 PACKAGE (59062-5100-1) * 177 mL in 1 TUBE (59062-1000-6) * 13 g in 1 APPLICATOR (59062-1200-1) 1 kit2017-01-010000-00-00NoNoCurrent