Home NDC 61354-083-01 Cream
Product NDC 61354-083
Requested package NDC 61354-083-01
11-digit product format 613540083
Labeler code 61354
Product ID 61354-083_e7757228-2748-0ae5-e053-2a95a90ac31c
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide
Dosage form CREAM
Route TOPICAL
Labeler Oxygen Development LLC
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-08-30
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 61354-083-01 Cream 100 mg in 1 TUBE CREAM 100 1 61354-083-01 Cream 1 in 1 CARTON CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-083 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220831_e7757228-2747-0ae5-e053-2a95a90ac31c.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 83 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dr. C. Tuna Lumi Radiance Brightening OCTOCRYLENE, OCTINOXATE, AVOBENZONE Farmasi US LLC adf5621b-7cf0-53b3-e053-2a95a90a8058 2026-01-09 Warnings Exact identifier application number: M020 Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15 HOMOSALATE, OCTINOXATE FARMASI US LLC 1dbd5e83-2248-4751-88d9-b446ccc3c61e 2026-01-09 Warnings Exact identifier application number: M020 Dr. C. Tuna Sunscreen 50 SPF UVA UVB Protection Face and Body Sun AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE Farmasi US LLC 27fdbd2b-60de-4906-a176-5c5198d9925b 2026-01-09 Warnings Exact identifier application number: M020 Skin Metal Stealth ZINC OXIDE Skin Metal 47f5d7de-5d32-041a-e063-6394a90ab6f9 2026-01-09 Warnings Exact identifier application number: M020 Salt and Blue Body Sunscreen SPF 30 ZINC OXIDE 20% Salt + Blue LLC 47f764a0-e9ad-ef66-e063-6394a90a8de5 2026-01-09 Warnings Exact identifier application number: M020 City Sunscreen serum Broad Spectrum SPF 30 Supergoop HOMOSALATE, OCTISALATE, AVOBENZENE, OCTOCRYLENE Supergoop, LLC 61766f7b-512d-45b5-b652-e09975a3d3fc 2026-01-09 Warnings Exact identifier application number: M020 Defense Refresh (Re)Setting Mist SPF 40 AVOBENZONE, HOMOSALATE , OCTISALATE, OCTOCRYLENE Supergoop LLC b95ad8e3-978b-b721-e053-2a95a90a1e54 2026-01-09 Warnings Exact identifier application number: M020 Daily Dose Vitamin C and Broad Spectrum SPF 40 Serum AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop LLC aed0dd03-1695-a5a9-e053-2995a90acfdc 2026-01-09 Warnings Exact identifier application number: M020 Hand Screen Broad Spectrum Sunscreen SPF 40 AVOBENZONE, OCTISALATE, OCTOCRYLENE Supergoop, LLC 972ebab9-3f2f-6716-e053-2a95a90a5c75 2026-01-09 Warnings Exact identifier application number: M020 Glow Oil Broad Spectrum Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop, LLC 972c68e7-b137-34c6-e053-2a95a90a77d6 2026-01-09 Warnings Exact identifier application number: M020 Poolside Frostbite Sunscreen Coconut SPF 15 Scented Lip Gloss HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE I World LLC ee045b64-7a95-4378-8183-e6e556f3b184 2026-01-09 Warnings Exact identifier application number: M020 Poolside Frostbite Sunscreen Papaya SPF 15 Scented Lip Gloss HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE I World LLC 967d0657-18fc-4e4a-b52d-442df43329f1 2026-01-09 Warnings Exact identifier application number: M020 PLAY SPF 30 Lip Shield Coconut AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop, LLC b0b8b850-bdfe-5563-e053-2995a90a51a7 2026-01-09 Warnings Exact identifier application number: M020 Play SPF 30 Lip Shield Strawberry AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop, LLC b0a49142-53c3-5b7a-e053-2995a90a581d 2026-01-09 Warnings Exact identifier application number: M020 Glow Stick Broad Spectrum SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE Supergoop, LLC 61e543e3-9ace-6440-e053-2991aa0a9647 2026-01-09 Warnings Exact identifier application number: M020 (RE) Setting 100% Mineral Powder Translucent Broad Spectrum Sunscreen SPF 35 ZINC OXIDE Supergoop, LLC af5c9801-26ce-5c60-e053-2995a90ab457 2026-01-09 Warnings Exact identifier application number: M020 (Re) Setting 100% mineral Powder Light Broad Spectrum SPF 35 ZINC OXIDE Supergoop, LLC aed5a7ef-5cf2-6738-e053-2a95a90aa7f7 2026-01-09 Warnings Exact identifier application number: M020 Play Mineral Broad Spectrum SPF 50 TITANIUM DIOXIDE, ZINC OXIDE Supergoop, LLC 89088ac5-f1ee-1996-e053-2a95a90a8fdc 2026-01-09 Warnings Exact identifier application number: M020 (RE) Setting 100% Mineral Powder Medium Broad Spectrum Sunscreen SPF 35 ZINC OXIDE Supergoop, LLC af4b0f17-43ec-a176-e053-2a95a90a7ac6 2026-01-09 Warnings Exact identifier application number: M020 (Re) Setting 100% mineral Powder Deep Broad Spectrum SPF 35 ZINC OXIDE Supergoop, LLC af4cb85b-1275-2105-e053-2995a90a7e74 2026-01-09 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 61354-083-01 61354008301 1 TUBE in 1 CARTON (61354-083-01) > 100 mg in 1 TUBE 1 tube 2022-08-30 0000-00-00 No No Current