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 179 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Buff ZINC OXIDE Cosmetic Enterprises Ltd 265bc5e0-0a2a-842e-e063-6394a90aae0a 2025-10-13 Warnings Exact identifier application number: M020 Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Mocha ZINC OXIDE Cosmetic Enterprises Ltd 2748b6bc-e80b-ce66-e063-6394a90a400a 2025-10-13 Warnings Exact identifier application number: M020 Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Bronze ZINC OXIDE Cosmetic Enterprises Ltd 265bf123-c4c3-8414-e063-6394a90a4730 2025-10-13 Warnings Exact identifier application number: M020 Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Ivory ZINC OXIDE Cosmetic Enterprises Ltd 2748c351-0a7d-6913-e063-6394a90a6ef2 2025-10-13 Warnings Exact identifier application number: M020 Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Nude ZINC OXIDE Cosmetic Enterprises Ltd 265bd73f-2509-90c6-e063-6294a90a2e19 2025-10-13 Warnings Exact identifier application number: M020 Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC dad4b244-2d34-40cb-88dc-991358df83b0 2025-10-10 Warnings Exact identifier application number: M020 Neutrogena Beach Defense Kids Sunscreen SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kenvue Brands LLC eafc00ce-12e7-921f-e053-2995a90a241a 2025-10-10 Warnings Exact identifier application number: M020 Meijer SPF 50 Sunscreen Mango AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Meijer 40d0294b-e937-336d-e063-6294a90a5c3c 2025-10-10 Warnings Exact identifier application number: M020 Vertra S Dorian Kona Gold Signature Face Stick SPF 38 TITANIUM DIOXIDE Eai-jr 286, Inc b6c316c3-661b-6428-e053-2a95a90a1a6b 2025-10-10 Warnings Exact identifier application number: M020 Meijer SPF 50 Sunscreen Coconut AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Meijer 40d15366-85b8-f5e8-e063-6294a90a5fd8 2025-10-10 Warnings Exact identifier application number: M020 Premium Moisturizing Sunscreen Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Wasatch Product Development, LLC f4369f2f-fdc3-e48e-e053-2995a90a07f7 2025-10-10 Warnings Exact identifier application number: M020 Sun Bum Face 50 Premium Sunscreen SPF 50 AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE Wasatch Product Development, LLC f4ac746a-a50a-8041-e053-2a95a90a8ea6 2025-10-10 Warnings Exact identifier application number: M020 Wonderscreen Broad Spectrum SPF 30 ZINC OXIDE Wasatch Product Development, LLC. e895d942-e50e-1ad6-e053-2995a90a0e02 2025-10-10 Warnings Exact identifier application number: M020 Illuminating SPF 50 plus drops Broad Spectrum Sunscreen ZINC OXIDE Cosmetic Enterprise Ltd 13f40485-b98e-e804-e063-6394a90af2af 2025-10-10 Warnings Exact identifier application number: M020 Impeccable Skin Moisturizing Face Sunscreen Broad Spectrum SPF 30 ZINC OXIDE Cosmetic Enterprises LTD a84d246b-1153-85ff-e053-2995a90a270a 2025-10-10 Warnings Exact identifier application number: M020 MediChoice Moisturizing Lip Balm SPF15 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE O&M HALYARD, INC. 00327815-28f0-4198-bca7-c8ae768ff416 2025-10-09 Warnings Exact identifier application number: M020 Daybird 4-in-1 Skin Tint Serum ZINC OXIDE Resette, Inc. 19c1a934-b0f5-1068-e063-6294a90a3b1f 2025-10-09 Warnings Exact identifier application number: M020 pavise Lip Defense tinted hydrating oil (hue 604) ZINC OXIDE B.A.I. Biosciences INC. f4ebbc1d-d521-1a47-e053-2a95a90a6f84 2025-10-09 Warnings Exact identifier application number: M020 pavise Lip Defense tinted hydrating oil (hue 774) ZINC OXIDE B.A.I. Biosciences INC. f4ebd850-11a8-0d43-e053-2a95a90a2d34 2025-10-09 Warnings Exact identifier application number: M020 pavise Lip Defense tinted hydrating oil (hue 616) ZINC OXIDE B.A.I. Biosciences INC. f4eb6b20-7c26-2942-e053-2a95a90abd31 2025-10-09 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