Home NDC 63712-201-01 BODY DEFENCE SUNSCREEN Broad Spectrum SPF30
Product NDC 63712-201
Requested package NDC 63712-201-01
11-digit product format 637120201
Labeler code 63712
Product ID 63712-201_96a4f339-5504-3dda-e053-2a95a90aed03
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Octisalate, Homosalate, Avobenzone, and Octocrylene
Dosage form OIL
Route TOPICAL
Labeler ZELENS Limited
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2016-05-01
Marketing end 0000-00-00
Substance OCTINOXATE; OCTISALATE; HOMOSALATE; AVOBENZONE; OCTOCRYLENE
Active strength 75 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
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 · 18 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…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…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63712-201-01 BODY DEFENCE SUNSCREEN Broad Spectrum SPF30 125 mL in 1 BOTTLE, PUMP OIL 125 2 63712-201-01 BODY DEFENCE SUNSCREEN Broad Spectrum SPF30 1 in 1 BOX OIL 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63712-201 BODY DEFENCE SUNSCREEN BROAD SPECTRUM SPF30 (OCTINOXATE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) OIL [ZELENS LIMITED] 2 Legacy NDC, 2 package rows 20191106_75d985ca-971d-4529-a9f0-685c8879b942.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63712-201-01 63712020101 1 BOTTLE, PUMP in 1 BOX (63712-201-01) > 125 mL in 1 BOTTLE, PUMP 2016-05-01 0000-00-00 No No Current