Home NDC 61354-084 Cream
Product NDC 61354-084
11-digit product format 613540084
Labeler code 61354
Product ID 61354-084_e7763ac1-d05c-7f8f-e053-2995a90a6c15
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61354-084-01 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61354-084-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61354-084-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61354-084-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61354-084-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61354-084-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61354-084-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61354-084-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61354-084-01 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 61354-084-01 Cream 100 mg in 1 TUBE CREAM 100 1 61354-084-01 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 61354-084 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220831_e7760899-8b4a-9a2a-e053-2995a90a2fd5.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 254 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BABYGANICS SPF 50 Plus SUNSCREEN ZINC OXIDE, OCTISALATE, AND OCTOCRYLENE KAS Direct LLC dba Babyganics 4075f9dc-c25f-434f-a3fc-a7f896295c3d 2024-12-20 Warnings Exact identifier application number: M020 Sunscreen HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE Total Resources International 7d4f820d-e154-428e-89c2-2e26e088ceef 2024-12-20 Warnings Exact identifier application number: M020 Babyganics Sheer Blend SPF50 Mineral Sunscreen ZINC OXIDE KAS Direct LLC dba BabyGanics edced0dc-dd43-4ac9-b816-f4edb45fc87b 2024-12-20 Warnings Exact identifier application number: M020 NARS Radiance Primer Broad Spectrum SPF 35 Sunscreen OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE COSMAX USA, CORPORATION 29ad7391-d932-3549-e063-6394a90ab2b2 2024-12-20 Warnings Exact identifier application number: M020 Face Reality daily spf 30 plus Sunscreen SPF 30 HOMOSALATE, OCTISALATE, AVOBENZONE Face Reality,LLC 45a3ce12-15fe-4040-95da-ac8513a39fb9 2024-12-20 Warnings Exact identifier application number: M020 Face Reality mineral matte spf 28 Sunscreen SPF 28 ZINC OXIDE, TITANIUM DIOXIDE Face Reality, LLC 29b70afe-cf9d-d0ba-e063-6394a90a1cc4 2024-12-20 Warnings Exact identifier application number: M020 Sonage Roux Tinted Day Creme with SPF 30 Sheer Tinted Moisturizer ZINC OXIDE ASA Universal Inc. dba: Sonage fd14d70c-6cd0-5de6-e053-6294a90a7add 2024-12-20 Warnings Exact identifier application number: M020 Coola SPF 50 Classic SUNSCREEN FACE MIST COOLA LLC d18d0dac-5690-436e-e053-2995a90a0254 2024-12-20 Warnings Exact identifier application number: M020 COOLA Mineral Body SPF 30 Tropical Coconut ZINC OXIDE COOLA, LLC eeb5d4f1-8cba-9ef6-e053-2a95a90a823f 2024-12-20 Warnings Exact identifier application number: M020 Oars and Alps SPF 50 100% Mineral Antioxidant Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Oars and Alps LLC f3971b85-a13e-4195-e053-2995a90a73cb 2024-12-20 Warnings Exact identifier application number: M020 Vacation SPF 30 Mineral ZINC OXIDE Vacation Inc. f69513ae-f210-075f-e053-2a95a90a9b2e 2024-12-20 Warnings Exact identifier application number: M020 Vacation SPF 30 Chardonnay Oil AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Vacation Inc. f694752d-4839-3768-e053-2995a90a5d3e 2024-12-20 Warnings Exact identifier application number: M020 Oars and Alps SPF 50 Hydrating Antioxidant SunscreenSpray AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Oars and Alps LLC ec5b82f5-b36c-fbc5-e053-2995a90afa0c 2024-12-20 Warnings Exact identifier application number: M020 Oars and Alps SPF 70 Hydrating Antioxidant Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Oars and Alps LLC f39673a7-0b62-bdf7-e053-2995a90aa2b7 2024-12-20 Warnings Exact identifier application number: M020 Carpe SPF 30 Face Primer TITANIUM DIOXIDE, ZINC OXIDE Clutch, Inc. DBA Carpe feac5ee2-faa5-fd17-e053-6394a90a7f99 2024-12-20 Warnings Exact identifier application number: M020 Oars and Alps SPF 50 Mineral ZINC OXIDE Oars and Alps LLC f395bc39-daa5-53b8-e053-2995a90a5f48 2024-12-20 Warnings Exact identifier application number: M020 Babyganics Kids Sheer Blend SPF50 Mineral Sunscreen ZINC OXIDE KAS Direct LLC dba BabyGanics 8a143645-3b52-4797-9b26-dc9dd63be38f 2024-12-20 Warnings Exact identifier application number: M020 Nuria Defend Matte Finish Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE Small World Brands b1df4c81-333b-450d-963e-6670ab9bbda9 2024-12-20 Warnings Exact identifier application number: M020 foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 8B porcelain beige TITANIUM DIOXIDE AND ZINC OXIDE Tarte, Inc. 062fa0d9-f384-48af-8269-42de3a788db1 2024-12-20 Warnings Exact identifier application number: M020 Stokoderm Sunscreen PURE AVOBENZONE, OCTOCRYLENE, OCTISALATE, AND HOMOSALATE SC Johnson Professional USA, Inc. 3ddf81e6-de78-4f2f-814b-c75eadcddb39 2024-12-20 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 61354-084-01 61354008401 1 TUBE in 1 CARTON (61354-084-01) > 100 mg in 1 TUBE 1 tube 2022-08-30 0000-00-00 No No Current