Home NDC 58411-292-60 CLE DE PEAU BEAUTE UV PROTECTIVE TINTED
Product NDC 58411-292
Requested package NDC 58411-292-60
11-digit product format 584110292
Labeler code 58411
Product ID 58411-292_7cf25316-219a-29bc-e053-2a91aa0ab049
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE
Dosage form CREAM
Route TOPICAL
Labeler SHISEIDO AMERICAS CORPORATION
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2017-02-01
Marketing end 0000-00-00
Substance OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE
Active strength 2449 mg/30mL; mg/30mL; mg/30mL
NDC exclude flag No
Listing certified through 2020-12-31
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58411-292-60 CLE DE PEAU BEAUTE UV PROTECTIVE TINTED IVORY 30 mL in 1 TUBE CREAM 30 2 58411-292-60 CLE DE PEAU BEAUTE UV PROTECTIVE TINTED IVORY 1 in 1 CARTON CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58411-292 CLE DE PEAU BEAUTE UV PROTECTIVE TINTED IVORY (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) CREAM CLE DE PEAU BEAUTE UV PROTECTIVE TINTED OCHER (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) CREAM CLE DE PEAU BEAUTE UV PROTECTIVE TINTED DARK (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) CREAM [SHISEIDO AMERICAS CORPORATION] 2 Legacy NDC, 2 package rows 20181214_7d9598f1-cbee-4e87-a8f1-067e01fd8833.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58411-292-60 58411029260 1 TUBE in 1 CARTON (58411-292-60) > 30 mL in 1 TUBE 1 tube 2017-02-01 0000-00-00 No No Current