Home NDC 76344-8005-2 Rejuve Sunscreen 100
Product NDC 76344-8005
Requested package NDC 76344-8005-2
11-digit product format 763448005
Labeler code 76344
Product ID 76344-8005_f1ec9ba8-a023-63c2-e053-2a95a90a72c6
Type HUMAN OTC DRUG
Nonproprietary name Inc Oxide,Octinoxate,Octisalate,Homosalate,Titanium Dioxide
Dosage form CREAM
Route TOPICAL
Labeler HUMEX,INC.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2020-12-01
Marketing end 0000-00-00
Substance HOMOSALATE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2024-12-31
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 · 11 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…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
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 76344-8005-1 Rejuve Sunscreen 100 50 mL in 1 TUBE CREAM 50 2 76344-8005-2 Rejuve Sunscreen 100 1 in 1 BOX CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76344-8005 REJUVE SUNSCREEN 100 (INC OXIDE,OCTINOXATE,OCTISALATE,HOMOSALATE,TITANIUM DIOXIDE) CREAM [HUMEX,INC.] 2 Legacy NDC, 2 package rows 20230111_b8cd9668-2b42-3336-e053-2a95a90a92dd.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76344-8005-2 76344800502 1 TUBE in 1 BOX (76344-8005-2) > 50 mL in 1 TUBE (76344-8005-1) 1 tube 2020-12-01 0000-00-00 No No Current