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 238 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join glo SKIN BEAUTY Moisturizing Tint SPF 30 GLO SKIN BEAUTY MOISTURIZING TINT SPF 30 Hayden Caleel LLC 2b464a70-8f40-3148-e063-6394a90ac18c 2025-01-09 Warnings Exact identifier application number: M020 Sunscreen and insect repellent Bull frog SPF 50 Bullfrog Brands, LLC d65d15a6-0a32-1203-e053-2995a90aa6c5 2025-01-09 Warnings Exact identifier application number: M020 Sunscreen and insect repellent Bull frog SPF 50 Bullfrog Brands, LLC d5fb3632-24da-2c7a-e053-2a95a90a5081 2025-01-09 Warnings Exact identifier application number: M020 Protect Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE NEW SEASON DERMATOLOGY, PLLC fecd72a3-c7e5-3dfa-e053-6394a90a7357 2025-01-09 Warnings Exact identifier application number: M020 ERBORIAN DOUBLE SAMPLE CC CREME CLAIR and DORE SPF 25 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 41b3cf18-dc11-4e1d-802e-5ba25bd87adb 2025-01-09 Warnings Exact identifier application number: M020 ECLIPSE SPF 50 PERFECTINT BEIGE TITANIUM DIOXIDE, ZINC OXIDE SCIENCE OF SKINCARE LLC b69dda25-372f-15d9-e053-2995a90a8d3e 2025-01-09 Warnings Exact identifier application number: M020 PerfecTint Powder SPF 40 All Shades ZINC OXIDE Science of Skincare bb26c010-299e-3dc5-e053-2995a90a2c89 2025-01-09 Warnings Exact identifier application number: M020 Extreme Protect SPF 40 All Shades ZINC OXIDE, TITANIUM DIOXIDE Science of Skincare, LLC. b69db78b-5f0e-8ca2-e053-2a95a90ac88c 2025-01-09 Warnings Exact identifier application number: M020 ECLIPSE SPF 50 ALL SHADES TITANIUM DIOXIDE, ZINC OXIDE SCIENCE OF SKINCARE LLC 49df51e6-be9a-41be-b3e1-bfc062aaceaa 2025-01-09 Warnings Exact identifier application number: M020 CoTZ Mineral Suns Stick - Tinted SPF 45 TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD 44a6ff9b-8067-4f32-acb2-4ede54c79e6e 2025-01-09 Warnings Exact identifier application number: M020 NUDESCREEN BLUSH TINT SPF 30 - SUNKISSED ZINC OXIDE SUNSCREEN Bentley Laboratories, LLC c45b59d8-0196-4dce-bfaa-57c47f655fe8 2025-01-09 Warnings Exact identifier application number: M020 TiZO Tinted Lip Protection SPF 45 TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD 81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a2 2025-01-09 Warnings Exact identifier application number: M020 CoTZ Face Prime and Protect SPF 40 (Tinted) TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD 1088fbf6-5790-490d-b272-ec281b4b76fa 2025-01-09 Warnings Exact identifier application number: M020 CoTZ Face Prime and Protect SPF 40 (Non-Tinted) TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD f106f52b-2157-46c7-9f7c-50f43a649050 2025-01-09 Warnings Exact identifier application number: M020 NUDESCREEN BLUSH TINT SPF 30 - SUNNY SWEET CHEEKS ZINC OXIDE SUNSCREEN Bentley Laboratories, LLC 5c98bacb-8bbd-47b8-8987-50be1ed34fc0 2025-01-09 Warnings Exact identifier application number: M020 CoTZ Face Moisture ZINC OXIDE Fallien Cosmeceuticals, LTD db682516-6c8f-4009-a9ec-e21dfc64ce15 2025-01-09 Warnings Exact identifier application number: M020 L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Light Medium OCTOCRYLENE, ZINC OXIDE L'BRI Health & Beauty bcd22c9a-2db6-4653-9ab5-825f3f5cc420 2025-01-08 Warnings Exact identifier application number: M020 L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Light OCTOCRYLENE, ZINC OXIDE L'BRI Health & Beauty c66c2a54-97c8-4904-a44a-b3cf790837f5 2025-01-08 Warnings Exact identifier application number: M020 Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Tempo Industries, Inc. af9aa56d-2f8a-55b9-e053-2a95a90a3258 2025-01-08 Warnings Exact identifier application number: M020 Baby Mineral Sunscreen Probiotics SPF55 ZINC OXIDE Hello Bello 0191b2e4-bcc5-541a-e063-6294a90a0e78 2025-01-08 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