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 91 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMY ZINC OXIDE Kao USA Inc. 26bcb9cd-bfb5-998c-e063-6394a90ab9d6 2026-01-05 Warnings Exact identifier application number: M020 HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUD ZINC OXIDE Kao USA Inc. 26cf1320-aae5-2ea0-e063-6394a90a3be2 2026-01-05 Warnings Exact identifier application number: M020 OZE SUN BONDI ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 47b1aae6-0b86-7d48-e063-6294a90a9ece 2026-01-05 Warnings Exact identifier application number: M020 Hybrid SPF SPF 30 OCTOCRYLENE, OCTISALATE, ZINC OXIDE Topiderm, Inc. 5c99f98c-025c-4886-824f-af968033baf4 2026-01-05 Warnings Exact identifier application number: M020 TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 Plus TITANIUM DIOXIDE HEY HONEY INC. 21187805-fae9-476c-81b0-27ffeb0b9911 2026-01-05 Warnings Exact identifier application number: M020 VEAKSON BEEF TALLOW SUNSCREEN ZINC OXIDE,PHENYLBENZIMIDAZOLE SULFONIC ACID Guangdong Aimu Biological Technology Co., Ltd 473c241a-1258-1680-e063-6394a90a7d98 2026-01-04 Warnings Exact identifier application number: M020 HYDRATING SUNSCREEN HYDRATING SUNSCREEN Guangzhou Yapeng Refinement Chemical Co., Ltd. 19a3687b-32b0-7c83-e063-6294a90aaf81 2026-01-04 Warnings Exact identifier application number: M020 Bellas Friends Sunscreen Stick ZINC OXIDE Panergytek Usa Inc 478cbdeb-28e4-fa56-e063-6294a90af124 2026-01-04 Warnings Exact identifier application number: M020 Bellas Friends Roll-on Sunscreen TITANIUM DIOXIDE, ZINC OXIDE PANERGYTEK USA INC 478d46ce-14e8-2231-e063-6394a90a3e27 2026-01-04 Warnings Exact identifier application number: M020 Ava Isa Sun Lip Sun Whip Clear Sunshine ZINC OXIDE Cyberderm Laboratories inc. a8646ee4-5e6e-6cdd-e053-2a95a90aee77 2026-01-01 Warnings Exact identifier application number: M020 Ava Isa Sun Lip Sun Whip Strawberry Zinnia ZINC OXIDE Cyberderm Laboratories inc. a888396f-489f-7e7c-e053-2995a90aee5b 2026-01-01 Warnings Exact identifier application number: M020 Ava Isa Sun Lip Sun Whip Watermelon Lily ZINC OXIDE Cyberderm Laboratories inc. a8889754-8e33-4d2a-e053-2995a90a6080 2026-01-01 Warnings Exact identifier application number: M020 OKeeffes Lip Repair AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTOCRYLENE The Gorilla Glue Company/O'Keeffe's Company 6805b3e9-77cb-bfee-e053-2991aa0a8d98 2026-01-01 Warnings Exact identifier application number: M020 Walgreens 50 Pina Colada Scented Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WALGREEN COMPANY 4978c811-be34-9fc3-e063-6394a90a2d80 2026-01-01 Warnings Exact identifier application number: M020 Unicorn Snot 35 SPF Glitter Spritz rose gold shimmer AVOBENZONE, OCTISALATE, OCTOCRYLENE Jailbreak Toys, Inc. DBA UNICORN SNOT 498b7c1a-e66d-9736-e063-6394a90a4712 2026-01-01 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Day Cream SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE BCM Ltd f7d5aa8a-9f4a-426b-ac9d-9690cf0103e0 2026-01-01 Warnings Exact identifier application number: M020 MAUI ISLAND SECRET BROWNING CREME Broad Spectrum Sunscreen SPF 5 ZINC OXIDE Formula 7venz L.L.C. 5f3cdec9-2cc2-4660-827f-d286883d907c 2025-12-31 Warnings Exact identifier application number: M020 SOLARA SUNCARE - GO VACATION GLOW SPF 30 ZINC OXIDE SOLARA SUNCARE, INC. 1f5cb694-f065-7ebc-e063-6394a90a883a 2025-12-31 Warnings Exact identifier application number: M020 SUNSCREEN GLOWING, SPF 30 SUNSCREEN GLOWING LOTION FSA Store Inc 473bcb90-ab7f-170b-e063-6294a90a99d5 2025-12-31 Warnings Exact identifier application number: M020 HAWAIIAN TROPIC AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 05ba5966-f0ff-5360-e063-6294a90a0fc9 2025-12-31 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