WL-AAE-ZT-O-408

Product NDC
63931-4557
Requested package NDC
63931-4557-1
11-digit product format
639314557
Labeler code
63931
Product ID
63931-4557_ed2069ac-155d-9129-e053-2995a90a44b0
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Nanophase Technologies Corporation
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-06-17
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
19 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63931-4557-163931455701150000 mL in 1 DRUM (63931-4557-1) 150000 ml2022-06-170000-00-00NoNoCurrent