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 224 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Obagi Skintrinsiq Firming Protocol TITANIUM DIOXIDE AND ZINC OXIDE Obagi Cosmeceuticals LLC 67ba9f32-bbf4-4c14-9e97-08f1cb7d3996 2025-03-21 Warnings Exact identifier application number: M020 Obagi Skintrinsiq Brightening Protocol HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC 2f75ebf7-d6b6-45c6-ad5b-61739d260ff7 2025-03-21 Warnings Exact identifier application number: M020 Hello Kitty Fun Broad Spectrum SPF 40 ZINC OXIDE The Creme Shop Inc 30d37581-122c-ec92-e063-6294a90ab425 2025-03-21 Warnings Exact identifier application number: M020 Hello Kitty Sunny Days Broad Spectrum SPF 40 ZINC OXIDE The Creme Shop Inc 30d3ed8c-f424-8d95-e063-6394a90a0cbc 2025-03-21 Warnings Exact identifier application number: M020 Carmex Variety Pack Daily Care Moisturizing Lip Balm SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. c7142781-fa57-43e5-9436-cb29dd03a669 2025-03-21 Warnings Exact identifier application number: M020 SHISEIDO ULTIMATE SUN PROTECTOR AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE SHISEIDO AMERICAS CORPORATION 00ec7d9c-8550-45ce-8d0a-ef2caf84f98d 2025-03-21 Warnings Exact identifier application number: M020 Obagi Skintrinsiq Clarifiying Protocol SALICYLIC ACID, TITANIUM DIOXIDE, AND ZINC OXIDE Obagi Cosmeceuticals LLC 08ba9ea8-73fd-472b-9cc4-67df167352ec 2025-03-21 Warnings Exact identifier application number: M020 Aveeno Kids Continuous Protection Sensitive Skin Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 3e51da46-6a81-4b74-b16e-3fc298a4ba59 2025-03-20 Warnings Exact identifier application number: M020 Neutrogena pure and free baby SUNSCREEN Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 2d2c58e2-0d15-4383-adae-12fc17b8ea50 2025-03-20 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Face and Body Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 1907126c-fd95-86e8-e063-6394a90a23ca 2025-03-20 Warnings Exact identifier application number: M020 Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 Plus ZINC OXIDE Kenvue Brands LLC 4504a10d-6130-4ec5-823a-ab970709e6d7 2025-03-20 Warnings Exact identifier application number: M020 Vertra Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Eai-jr 286, Inc 30caf1dd-142d-85d3-e063-6394a90a0c88 2025-03-20 Warnings Exact identifier application number: M020 Sun Shades Lip Balm Cranberry Tangerine AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% Melaleuca Inc. f39606be-19c8-58d1-e053-2a95a90a908f 2025-03-20 Warnings Exact identifier application number: M020 Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 15) HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC aa937596-2378-469f-a0e1-9700044e83b3 2025-03-20 Warnings Exact identifier application number: M020 Obagi Medical Way to Glow Kit HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC f6f6e219-4ef6-be3b-e053-6294a90a660d 2025-03-20 Warnings Exact identifier application number: M020 Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20) HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC e8d19915-8996-42df-a47b-2ce00d2bbe68 2025-03-20 Warnings Exact identifier application number: M020 SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42 ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDE SHISEIDO AMERICAS CORPORATION 21bde283-a554-45c8-8733-2a8adeff41b1 2025-03-20 Warnings Exact identifier application number: M020 SHISEIDO ULTIMATE SUN PROTECTOR OCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONE SHISEIDO AMERICAS CORPORATION 7a98171f-bf21-40d4-bc78-883aa0b0c438 2025-03-20 Warnings Exact identifier application number: M020 Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 5e2d7c94-d70a-47e4-9a4b-5953fe38ede2 2025-03-19 Warnings Exact identifier application number: M020 Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 50206f9e-2dd5-494f-9eed-f7d7ea6efda9 2025-03-18 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