Home NDC 10028-060-04 Ultra UV Protective Mineral Defence
Product NDC 10028-060
Requested package NDC 10028-060-04
11-digit product format 100280060
Labeler code 10028
Product ID 10028-060_9c36dd65-6366-cc3b-e053-2a95a90af6be
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Ultraceuticals Pty Ltd
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2020-01-10
Marketing end 0000-00-00
Substance ZINC OXIDE
Active strength 127 mg/mL
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10028-060-04 10028006004 1 TUBE in 1 CARTON (10028-060-04) > 5 mL in 1 TUBE (10028-060-03) 1 tube 2020-01-10 0000-00-00 Yes No Current