Infinitek

Product NDC
58443-0363
11-digit product format
584430363
Labeler code
58443
Product ID
58443-0363_b0b30e06-0a0d-6755-e053-2a95a90a685f
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Prime Enterprises Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-05-30
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
42 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0363-32023-01-30C16284748780-1f386c64a-2c46-0266-e053-dadaa90a7c1aIINFINITEK PARIS Broad Spectrum SPF 50 Mineral Face Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0363-3InfinitekSPF 50 Mineral50 mL in 1 TUBELOTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0363INFINITEK SPF 50 MINERAL (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PRIME ENTERPRISES INC.]1Legacy NDC, 1 package rows20201014_b0b30e0f-c733-5cd2-e053-2a95a90ad8cc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0363-35844303630350 mL in 1 TUBE (58443-0363-3) 50 ml2019-05-300000-00-00NoNoCurrent