Home NDC 83612-0282 Organys Derma Made
Product NDC 83612-0282
11-digit product format 836120282
Labeler code 83612
Product ID 83612-0282_40c0942a-1318-6a67-e063-6294a90af373
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Organys Beauty
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-24
Substance ZINC OXIDE
Active strength 132 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes
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 · 10 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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Organys Derma Made
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 132 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83612-0282-1 Organys Derma Made 45 mL in 1 BOTTLE, PUMP LOTION 45 5 83612-0282-2 Organys Derma Made 5 mL in 1 BOTTLE LOTION 5 5 83612-0282-3 Organys Derma Made 45 mL in 1 TUBE LOTION 45 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83612-0282 ORGANYS DERMA MADE (ZINC OXIDE) LOTION [ORGANYS BEAUTY] 3 Current NDC, 3 package rows 20241004_09b8b8c0-4066-9cbe-e063-6394a90aca24.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 46 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Arizona Sun Sunscreen SPF 30 SUNSCREEN Arizona Sun Products 10e276e4-81f1-9429-e063-6394a90a800d 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Sunscreen SPF 8 SUNSCREEN Arizona Sun Products 106a9608-f7a4-0f8c-e063-6394a90a26ab 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Bikerblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fced72-39f9-f3a3-e063-6294a90a8b73 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Golfblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fc2a82-260c-7cd3-e063-6394a90af2c1 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Cycleblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fd9aa5-dbd6-e5a7-e063-6394a90a3eac 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Golfblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fc93a7-f5be-965d-e063-6394a90ab335 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Bikerblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fd1661-1b91-b65b-e063-6394a90af89b 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Lipkist Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fbcb81-2735-53c8-e063-6394a90ab0fa 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Cycleblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fd8776-99f8-e5a4-e063-6394a90a2033 2026-04-09 Warnings Exact identifier application number: M020 uLOOK Sunscreen SPF 50 SUNSCREEN HAMEX GLOBAL COSMETICS LLC 4e05588c-486b-60e0-e063-6294a90af457 2026-04-09 Warnings Exact identifier application number: M020 Pro-Tect Sports Sunscreen SPF 20 MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE ABBE Laboratories, Inc. 35869e8d-8e48-4b22-8af3-6964fe8ac182 2026-04-09 Warnings Exact identifier application number: M020 Sunright 50 AVOBENZONE, HOMOSALATE, AND OCTINOXATE NSE Products, Inc. b1b76481-da23-427f-9b34-b987019fa532 2026-04-09 Warnings Exact identifier application number: M020 ThinkBaby SPF 30 ZINC OXIDE thinkOperations,LLC 06862b00-c937-41af-ab5d-cea34160d035 2026-04-09 Warnings Exact identifier application number: M020 Nutricentials Day Dream Protective HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE NSE Products, Inc. 4a376e93-85e8-40a5-8641-d3e3d11fdeea 2026-04-08 Warnings Exact identifier application number: M020 AGE20S SUNSCREEN DUO ZINC OXIDE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Aekyung Industrial Co., Ltd. 4eef11cd-85a1-0e44-e063-6394a90a5d44 2026-04-08 Warnings Exact identifier application number: M020 Neutrogena MINERAL UV TINT FACE DEEP SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Acupac Packaging, Inc. 4ef430e8-cdc8-2897-e063-6394a90a3ac7 2026-04-08 Warnings Exact identifier application number: M020 Neutrogena MINERAL UV TINT FACE LIGHT SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Acupac Packaging, Inc. 4ef4a822-a7ab-b374-e063-6394a90a8508 2026-04-08 Warnings Exact identifier application number: M020 Neutrogena MINERAL UV TINT FACE MEDIUM SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Acupac Packaging, Inc. 4ef4d44e-3421-535f-e063-6294a90a2fea 2026-04-08 Warnings Exact identifier application number: M020 Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank Moisturizer AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Acupac Packaging, Inc. 4ef5baf7-00b1-97aa-e063-6294a90aab9c 2026-04-08 Warnings Exact identifier application number: M020 Neutrogena Mineral Ultra Sheer Face SPF 70 TITANIUM DIOXIDE, ZINC OXIDE Acupac Packaging, Inc. 4ef5dcd4-b2d0-bcd1-e063-6294a90a871f 2026-04-08 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83612-0282-1 83612028201 45 mL in 1 BOTTLE, PUMP 45 ml Historical 83612-0282-2 83612028202 5 mL in 1 BOTTLE (83612-0282-2) 5 ml 2023-08-21 Yes No Current 83612-0282-3 83612028203 45 mL in 1 TUBE (83612-0282-3) 45 ml 2023-07-24 No No Current