Home NDC 61354-082 Cream
Product NDC 61354-082
11-digit product format 613540082
Labeler code 61354
Product ID 61354-082_e724e10c-4f05-b03d-e053-2a95a90a754c
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide
Dosage form LOTION
Route TOPICAL
Labeler Oxygen Development LLC
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-08-26
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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 Cream 1 in 1 CARTON LOTION 1 1 61354-082-01 Cream 100 mg in 1 TUBE LOTION 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-082 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220827_e724e098-f5c9-262a-e053-2995a90a2a02.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 233 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zealios SPF LipGuard OCTISALATE AND AVOBENZONE Personal Best Products Inc. dba Zealios 3a07822b-a7c9-40af-a8f7-bea591c7a49b 2025-01-13 Warnings Exact identifier application number: M020 SPF-30 BB ZINC OXIDE ZION HEALTH 66d33d8c-8900-4698-98fe-0dedafe674d8 2025-01-13 Warnings Exact identifier application number: M020 Priia Tinted Mineral Sunscreen and Primer TITANIUM DIOXIDE, ZINC OXIDE Priia Cosmetics Inc b2addf27-9139-48b4-85e6-618f4b5311cc 2025-01-13 Warnings Exact identifier application number: M020 Skin Apeel Ageless Defense SPF 40 Broad Spectrum ZINC OXIDE Skin Apeel, Inc. c3bbe779-b012-4f19-8b90-2c7a4dd88617 2025-01-13 Warnings Exact identifier application number: M020 UNCOMPLIKATED MAKEUP SETTING SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE KATE SOMERVILLE SKINCARE LLC 1a33cb41-440a-41cb-9832-24255bfa2b7c 2025-01-12 Warnings Exact identifier application number: M020 ALLSWELL MINERAL SUNSCREEN SPF 30 ZINC OXIDE Stream2Sea, LLC 03bee988-d6e3-4290-a926-9c5366649cba 2025-01-12 Warnings Exact identifier application number: M020 Baby Donna SHeer SPF Sunscreen Stick ZINC OXIDE Stream2Sea, LLC a1b1cdeb-e5fe-4ba1-8bb0-3c7a97dd93fe 2025-01-12 Warnings Exact identifier application number: M020 SUN PROTECT LIP BALM SPF 30 ZINC OXIDE AND TITANIUM DIOXIDE Stream2Sea, LLC 21386652-b952-48be-b077-1acecc7f0eb0 2025-01-12 Warnings Exact identifier application number: M020 Bondi Sands SPF 60 Sunny Body AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE BONDI SANDS (USA) INC. 2b5aebed-49f6-7bb8-e063-6294a90a8521 2025-01-10 Warnings Exact identifier application number: M020 Bondi Sands SPF 60 Sunny Drops Face Serum AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE BONDI SANDS (USA) INC. 2b5c69e4-2819-94ef-e063-6394a90a68e7 2025-01-10 Warnings Exact identifier application number: M020 Dermaroller Anhydrous Sunscreen SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Owen Biosciences, Inc. 04e82f1b-c893-4795-b7a9-0523e3ec7552 2025-01-10 Warnings Exact identifier application number: M020 Skinfuse Shield SPF 30 ZINC OXIDE Owen Biosciences, Inc. b8e4c11a-4b4f-4e36-a75e-0a73913113d5 2025-01-10 Warnings Exact identifier application number: M020 Correct and Protect Serum Broad Spectrum SPF 45 ZINC OXIDE Murad, LLC 60c62108-6806-4722-a44b-f1c300d59c1e 2025-01-10 Warnings Exact identifier application number: M020 Multi Vitamin Clear Coat Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Murad, LLC e023c874-c89d-4bd0-a0b9-a8161c261457 2025-01-10 Warnings Exact identifier application number: M020 CoTZ Baby ZINC OXIDE Fallien Cosmeceuticals, LTD 17cc12c7-5af8-413f-b205-31ac150583e2 2025-01-09 Warnings Exact identifier application number: M020 ISNTREE HYALURONIC ACID DAILY SUNGEL AVOBENZONE, HOMOSALATE, OCTISALATE ISNTREE Inc. 2b3bdbe1-ede9-cd60-e063-6394a90ab2f3 2025-01-09 Warnings Exact identifier application number: M020 JAFRA ROYAL REVITALIZE 4 TUBE SET AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Distribuidora Comercial Jafra, S.A. de C.V. b4a0d6ab-50a7-43e7-9d7e-a4c01d7eca98 2025-01-09 Warnings Exact identifier application number: M020 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61354-082-01 61354008201 1 TUBE in 1 CARTON (61354-082-01) > 100 mg in 1 TUBE 1 tube 2022-08-26 0000-00-00 No No Current