FDA.reportPublic FDA data

SPF 50 Mineral Sunscreen

Product NDC
59062-1001
Requested package NDC
59062-1001-2
11-digit product format
590621001
Labeler code
59062
Product ID
59062-1001_f3ca0977-4121-4da8-9a14-e4fcdd2e932d
Type
HUMAN OTC DRUG
Nonproprietary name
titanium dioxide and zinc oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
KAS Direct LLC dba BabyGanics
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-03-01
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
32 mg/mL; 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 packagepackage59062-100159062-1001-2DDiscontinued by firm2026-10-05

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
59062-1001SPF 50 MINERAL SUNSCREEN BABYGANICS (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION SPF 50 MINERAL SUNSCREEN BKIDS (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]3Legacy NDC20241226_5453cd31-e70b-4f6c-81ce-206b960a54bc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59062-1001-25906210010259 mL in 1 TUBE (59062-1001-2) 59 ml2021-03-010000-00-00NoNoCurrent