Home NDC 61354-082-01 Cream
Product NDC 61354-082
Requested package NDC 61354-082-01
11-digit product format 613540082
Labeler code 61354
Product ID 61354-082_e724e10c-4f05-b03d-e053-2a95a90a754c
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide
Dosage form LOTION
Route TOPICAL
Labeler Oxygen Development LLC
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-08-26
Marketing end 0000-00-00
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 5 mg/100mg; mg/100mg
NDC exclude flag No
Listing certified through 2023-12-31
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 61354-082-01 Cream 1 in 1 CARTON LOTION 1 1 61354-082-01 Cream 100 mg in 1 TUBE LOTION 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-082 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220827_e724e098-f5c9-262a-e053-2995a90a2a02.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 227 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EMMA LEWISHAM Sunceutical SPF 50 Mineral Glow Serum ZINC OXIDE 20% EMMA LEWISHAM US, INC. 2b097709-913f-d906-e063-6394a90a0446 2025-02-05 Warnings Exact identifier application number: M020 EMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream ZINC OXIDE 20% EMMA LEWISHAM US, INC. 2c703df8-23af-d630-e063-6294a90a1a24 2025-02-05 Warnings Exact identifier application number: M020 doTERRA Sun ZINC OXIDE doTERRA International, LLC dd308fef-e312-4ced-e053-2995a90a76fd 2025-02-05 Warnings Exact identifier application number: M020 OrgaPlus Ultra Pure Sun EX 15g OCTINOXATE, OCTISALATE, OCTOCRYLENE BLUEZONWIDE CO.,LTD b686ef63-7eee-4a4d-a559-417d8b09cc4f 2025-02-05 Warnings Exact identifier application number: M020 OrgaPlus Ultra Pure Sun EX 22g OCTINOXATE, OCTISALATE, OCTOCRYLENE BLUEZONWIDE CO.,LTD d3c422f6-a83d-48fc-94fc-2749666426c8 2025-02-05 Warnings Exact identifier application number: M020 EMMA LEWISHAM Sunceutical SPF 50 Mineral Body Cream ZINC OXIDE 20% EMMA LEWISHAM US, INC. 2d65b2d0-7013-d0ad-e063-6394a90ad4c2 2025-02-05 Warnings Exact identifier application number: M020 Olay Sun Hydrating Facial Moisturizer with Sunscreen SPF 30 Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE The Procter & Gamble Manufacturing Company 2d6a6fed-a26e-e3a6-e063-6394a90ae2c7 2025-02-05 Warnings Exact identifier application number: M020 Brush On Block Sheer Genius SPF 50 Mineral Moisture ZINC OXIDE SPF Ventures, LLC 2d4b8c92-b932-89a7-e063-6394a90a621d 2025-02-04 Warnings Exact identifier application number: M020 Seven Thirty Daily Habit Broad Spectrum SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE SAN DIEGO NATURAL SOAP COMPANY 30ca8f9d-b6a5-4af0-9d7b-487212e40e63 2025-02-03 Warnings Exact identifier application number: M020 Atlanta Acne Specialist Everyday Sunscreen SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE SAN DIEGO NATURAL SOAP COMPANY 3057f8ad-5850-49a0-b44d-3a1da84126e3 2025-02-03 Warnings Exact identifier application number: M020 TiZO Ultra Zinc SPF 40 (Tinted) ZINC OXIDE Fallien Cosmeceuticals, LTD. 2d3faa43-0d78-58de-e063-6294a90a0b17 2025-02-03 Warnings Exact identifier application number: M020 TiZO Eye Renewal SPF 20 (Non-Tinted) ZINC OXIDE Fallien Cosmeceuticals, LTD 2d40099a-2cfa-1d99-e063-6394a90a36a6 2025-02-03 Warnings Exact identifier application number: M020 Brush On Block SPF 30 Mineral Powder Translucent Zinc Only-Refill ZINC OXIDE SPF Ventures, LLC 2d47eb76-e644-4e04-e063-6294a90a93cc 2025-02-03 Warnings Exact identifier application number: M020 Brush On Block Sun Shine SPF 30 Protective Lip Oil Peony Tint TITANIUM DIOXIDE/ZINC OXIDE SPF Ventures LLC 2d490531-af36-87d0-e063-6394a90acf49 2025-02-03 Warnings Exact identifier application number: M020 YOUR TINTED MOISTURIZER HYDRATING ANTI AGING BROAD SPECTRUM SPF 30 OCTISALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE Skin Ai, LLC 2d8b7d07-2249-898b-e063-6394a90af6ad 2025-02-01 Warnings Exact identifier application number: M020 ESSENCE LIGHT SUNSCREEN SPF 50 PA AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ENGLEWOOD LAB, INC. f5c79f1a-cecd-2409-e053-2995a90ad06f 2025-01-31 Warnings Exact identifier application number: M020 RODAN - FIELDS ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Rodan & Fields 67b55df8-9623-4352-b136-b0bc8d1efe02 2025-01-31 Warnings Exact identifier application number: M020 Oil-Free Daily Hydration SPF 15 OCTINOXATE, AVOBENZONE Boscia LLC ec322ae5-ab03-4c7b-9c6d-0bda3327c72a 2025-01-31 Warnings Exact identifier application number: M020 PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Paula's Choice, Inc b90658d0-e422-4265-a6ee-39c29b6c116a 2025-01-31 Warnings Exact identifier application number: M020 SunStation USA SPF-30 SPORT SUNSCREEN ZINC OXIDE RENU LABORATORIES, LLC 11d3c60e-238d-999e-e063-6394a90a624b 2025-01-31 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61354-082-01 61354008201 1 TUBE in 1 CARTON (61354-082-01) > 100 mg in 1 TUBE 1 tube 2022-08-26 0000-00-00 No No Current