FDA.reportPublic FDA data

DECORTE AQ UV PROTECTION

Product NDC
66820-0300
Requested package NDC
66820-0300-3
11-digit product format
668200300
Labeler code
66820
Product ID
66820-0300_ee3c4a33-e994-da48-e053-2995a90a09cb
Type
HUMAN OTC DRUG
Nonproprietary name
titanium dioxide, zinc oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
KOSE AMERICA, INC.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-03-01
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
128 mg/mL; mg/mL
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 packagepackage66820-030066820-0300-3DDiscontinued by firm2026-10-15

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
66820-0300DECORTE AQ UV PROTECTION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [KOSE AMERICA, INC.]3Legacy NDC20241020_c6bddc60-2a00-4405-9c4a-48626ee55eb4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66820-0300-366820030003.5 mL in 1 PACKET (66820-0300-3) 2022-03-010000-00-00NoNoCurrent