United Spirit of America

Product NDC
58443-0240
11-digit product format
584430240
Labeler code
58443
Product ID
58443-0240_ca90a053-663f-b8d7-e053-2a95a90aa534
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
2016-08-11
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
45 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0240-35844302400388.7 mL in 1 BOTTLE (58443-0240-3) 88.7 ml2016-08-160000-00-00NoNoCurrent