Home NDC 82084-0011-0 AGELESS SOLAR DEFENSE (SPF 30)
Product NDC 82084-0011
Requested package NDC 82084-0011-0
11-digit product format 820840011
Labeler code 82084
Product ID 82084-0011_c670d299-14cb-64d7-e053-2a95a90aba34
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE
Dosage form CREAM
Route TOPICAL
Labeler Divine 369 LLC
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2021-07-15
Marketing end 0000-00-00
Substance OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE
Active strength 75 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2022-12-31
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 82084-0011-0 AGELESS SOLAR DEFENSE (SPF 30) 50 mL in 1 BOTTLE, PUMP CREAM 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82084-0011 AGELESS SOLAR DEFENSE (SPF 30) (OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE) CREAM [DIVINE 369 LLC] 3 Legacy NDC, 1 package rows 20230202_56619591-07f2-4ad9-9d06-2930491b191b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 82084-0011-0 82084001100 50 mL in 1 BOTTLE, PUMP (82084-0011-0) 50 ml 2021-07-15 0000-00-00 No No Current