FDA.reportPublic FDA data

Ourself Mineral Sunscreen

Product NDC
82325-4482
Requested package NDC
82325-4482-2
11-digit product format
823254482
Labeler code
82325
Product ID
82325-4482_ceb74d3c-4376-4f2f-e053-2a95a90ab848
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
GLO PHARMA
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-10-22
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
12 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 packagepackage82325-448282325-4482-2DDiscontinued 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
82325-4482OURSELF MINERAL SUNSCREEN (ZINC OXIDE) LOTION [GLO PHARMA]6Legacy NDC20241027_ceb7531b-60a8-3275-e053-2a95a90a41d1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82325-4482-2823254482021 BOTTLE, PUMP in 1 CARTON (82325-4482-2) > 30 mL in 1 BOTTLE, PUMP (82325-4482-1) 2021-10-220000-00-00NoNoCurrent