Home NDC 50518-203-11 FACE BALM SPF-15
Product NDC 50518-203
Requested package NDC 50518-203-11
11-digit product format 505180203
Labeler code 50518
Product ID 50518-203_db655cdc-9bcf-1aa6-e053-2a95a90a7f2e
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form LOTION
Route TOPICAL
Labeler CUSTOM RESEARCH LABS
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2021-07-06
Marketing end 0000-00-00
Substance ZINC OXIDE
Active strength 20 g/100mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2023-12-31
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 2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 50518-203-11 50518020311 118 mL in 1 JAR (50518-203-11) 118 ml 2021-07-06 0000-00-00 No No Current