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 211 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Naturium Phyto-Glow Lip Balm SPF 45-Clear AVOBENZONE, HOMOSALATE, OCTISALATE e.l.f. Cosmetics, Inc. 3806e2f2-ffd1-6d69-e063-6394a90acb44 2025-06-09 Warnings Exact identifier application number: M020 Naturium Phyto-Glow Lip Balm SPF 45-Getaway AVOBENZONE, HOMOSALATE, OCTISALATE e.l.f. Cosmetics, Inc. 3808613f-88d6-6c1a-e063-6294a90a5bb2 2025-06-09 Warnings Exact identifier application number: M020 1000 Roses Daily Shade Facial SPF 18 OCTISALATE, OCTOCRYLENE, AND AVOBENZONE Andalou naturals 0923e090-6834-4373-80fe-21f00b8c1c17 2025-06-09 Warnings Exact identifier application number: M020 dAlba Vegan Fresh Sun Cushion ZINC OXIDE, HOMOSALATE, OCTOCRYLENE ADMTMAX LLC 20afcbab-a2f4-7965-e063-6294a90a83d1 2025-06-08 Warnings Exact identifier application number: M020 dAlba Vegan Mild Sunscreen ZINC OXIDE ADMTMAX LLC 20ab5698-cd9f-0821-e063-6394a90a60d7 2025-06-08 Warnings Exact identifier application number: M020 dAlba Vegan Fresh Sun Stick HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE ADMTMAX LLC 20ae82ae-bc8f-89d1-e063-6394a90afff2 2025-06-08 Warnings Exact identifier application number: M020 dAlba Vegan Essence Sunscreen HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE ADMTMAX LLC 1ccfa213-2f83-ad50-e063-6294a90a38bf 2025-06-08 Warnings Exact identifier application number: M020 Pacifica Ultra CC Cream Radiant Foundation SPF 30 Warm/Medium ZINC OXIDE Pacifica Beauty, LLC 36ec6c9d-f7dc-0419-e063-6294a90a55e6 2025-06-06 Warnings Exact identifier application number: M020 Pacifica Ultra CC Cream Radiant Foundation SPF 30 Neutral/Fair ZINC OXIDE Pacifica Beauty, LLC 36ed9101-249a-922c-e063-6394a90a2608 2025-06-06 Warnings Exact identifier application number: M020 Rodan and Fields Reverse Brightening Defense Broad Spectrum SPF 50 Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Rodan & Fields Beauty, LLC afa2d42e-b54d-4843-b313-0c44fe5c5d52 2025-06-06 Warnings Exact identifier application number: M020 1000 Roses CC Color Plus Correct Sheer Tan SPF 30 ZINC OXIDE Andalou naturals 9314e4fc-ba3e-480e-a005-b8928130ed70 2025-06-06 Warnings Exact identifier application number: M020 Neutrogena Sheer Zinc Face Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 3169bf3b-a5a8-4c3e-a182-9f24f8ade3ac 2025-06-05 Warnings Exact identifier application number: M020 Body Glove Sunscreen SPF 30 ZINC OXIDE, TITANIUM DIOXIDE SCUBASCREEN LLC 1d7a960c-4387-44dc-8d4e-881e21a8ae2e 2025-06-05 Warnings Exact identifier application number: M020 Vacation Classic Mini Whip SPF 30 Broad Spectrum SPF 30 HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE Vacation Inc. 36d65cb2-c2e7-06d7-e063-6394a90a3822 2025-06-05 Warnings Exact identifier application number: M020 Vacation Classic Whip SPF 50 Broad Spectrum SPF 50 HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE Vacation Inc. 36d747fb-b973-5611-e063-6394a90ac661 2025-06-05 Warnings Exact identifier application number: M020 Non Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE BABYFACE LLC 36d7c8b3-554f-78d9-e063-6394a90a80f3 2025-06-05 Exact identifier application number: M020 Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE BABYFACE LLC 36d80422-943f-3aba-e063-6294a90afb59 2025-06-05 Exact identifier application number: M020 Mineral Creme SPF 50 Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min) TITANIUM DIOXIDE AND ZINC OXIDE MDSolarSciences f8e178d6-058c-462a-8e59-6721f28ad040 2025-06-05 Warnings Exact identifier application number: M020 Mineral Tinted SPF 30 Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min) TITANIUM DIOXIDE AND ZINC OXIDE MDSolarSciences adcd6881-fa25-4312-95e5-5b47102aa6b9 2025-06-05 Warnings Exact identifier application number: M020 Mineral Moisture Defense SPF 50 TITANIUM DIOXIDE AND ZINC OXIDE MDSolarSciences 05ad73f3-a4e8-4f78-8212-3e8e3bda988c 2025-06-05 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