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 269 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Coral Care SPF 30 Sunscreen TITANIUM DIOXIDE 8.8% Stream2Sea 2749fa0e-aed5-6c9a-e063-6294a90a2bf1 2024-11-19 Warnings Exact identifier application number: M020 FULL SPECTRUM MATTE AMBITION SKIN PRIMER SPF 20 ENSULIZOLE Noxell Corporation 82f7bff9-718e-19ea-e053-2991aa0a3560 2024-11-19 Warnings Exact identifier application number: M020 Rimmel London Lasting Finish 25 HR Foundation SPF 20 OCTINOXATE Rimmel cfd041e9-ed40-dc93-e053-2995a90a9699 2024-11-19 Warnings Exact identifier application number: M020 ultimate miracle worker multi-rejuvenating spf 30 AVOBENZONE, OCTINOXATE, OCTOCRYLENE Philosophy, Inc. 4387abab-ee1c-4e93-bea9-01624e8b4832 2024-11-19 Warnings Exact identifier application number: M020 Sun Voyage Kit AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Koco Life LLC 2732a8d2-6f56-c088-e063-6294a90af308 2024-11-18 Warnings Exact identifier application number: M020 Eminence Radiant Protection SPF Fluid ZINC OXIDE Eminence Organic Skin Care 002a4766-0c7e-4ec7-e063-6294a90a78d8 2024-11-18 Warnings Exact identifier application number: M020 Eryfotona Actinica Ultralight Emulsion SUNSCREEN ISDIN Corp 1d4b88d3-bee9-102c-e054-00144ff8d46c 2024-11-18 Warnings Exact identifier application number: M020 Rodan and Fields Plumping Lip SPF 28 Sunscreen OCTINOXATE, ZINC OXIDE Rodan & Fields edf05ccc-4299-48d5-8f8e-01255eca11c2 2024-11-15 Warnings Exact identifier application number: M020 Melan Mineral Antioxidant Body Mist Mineral Sunscreen SPF 30 ZINC OXIDE MELAN INC. 210823a0-94f9-4833-b279-fc26b9061195 2024-11-14 Warnings Exact identifier application number: M020 Luminous Sunscreen SPF 50 ZINC OXIDE, TITANIUM DIOXIDE CLINICAL SKIN LLC 26e2b82c-8d7a-7261-e063-6394a90a7c0d 2024-11-14 Warnings Exact identifier application number: M020 CoTZ Flawless Complexion ZINC OXIDE Fallien Cosmeceuticals, LTD 0973223b-e75f-4eb8-bcf1-7931b30b7b51 2024-11-14 Warnings Exact identifier application number: M020 TiZO Photoceutical Environmental Skin Protectant DIMETHICONE Fallien Cosmeceuticals, LTD 84a3299d-9b98-492e-a83f-ebd72ec58f8d 2024-11-14 Warnings Exact identifier application number: M020 TiZO Photoceutical AM Replenish Non-Tinted ZINC OXIDE Fallien Cosmeceuticals, LTD c52a1e04-f3ca-47a1-a26e-d6f5e77b47d6 2024-11-14 Warnings Exact identifier application number: M020 Neutrogena MINERAL UV TINT FACE LIGHT SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC e7af4f58-90c8-2987-e053-2995a90a416b 2024-11-13 Warnings Exact identifier application number: M020 Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Classic Ivory 10 TITANIUM DIOXIDE Kenvue Brands LLC 143e0a1d-305f-9015-e063-6294a90aa025 2024-11-13 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 05cb5a91-205f-b652-e063-6294a90a0664 2024-11-13 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC 18e40353-5c95-4d64-e063-6394a90a017c 2024-11-12 Warnings Exact identifier application number: M020 Neutrogena Healthy Skin Liquid Makeup SPF 20 - Classic Ivory 10 TITANIUM DIOXIDE Kenvue Brands LLC e0ed4537-8146-45e8-e053-2995a90ac51b 2024-11-12 Warnings Exact identifier application number: M020 Arbonne AgeWell Moisture Restoring Broad Spectrum SPF 15 Sunscreen ZINC OXIDE Arbonne International, LLC c172f793-3f7a-47b3-9db1-58487b8ad66c 2024-11-12 Warnings Exact identifier application number: M020 Hello Sunday The Everyday One Face Moisturiser SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kao USA Inc. 0c7e1aa2-7054-435d-e063-6394a90a2d08 2024-11-12 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