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 209 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Proven Personalized Day Moisturizer Sunscreen SPF 30 ZINC OXIDE Proven Skincare 5275d2c5-96e8-424d-a3c8-feea778191e4 2025-06-20 Warnings Exact identifier application number: M020 LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N OCTINOXATE, ZINC OXIDE BEL STAR SA f9266687-73d2-dac9-e053-6394a90ac2a1 2025-06-20 Warnings Exact identifier application number: M020 LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50 AVOBENZONE, HOMOSALATE, OCTOCRYLENE BEL STAR SA fd0465aa-df1e-ce1c-e053-6294a90a2302 2025-06-20 Warnings Exact identifier application number: M020 FEIBTH TALLOW SUNSCREEN TALLOW SUNSCREEN Guangzhou Qiexiran Cosmetics Co., Ltd. 37ead2b1-12d4-af92-e063-6394a90af0d6 2025-06-19 Warnings Exact identifier application number: M020 LipBOMB TITANIUM DIOXIDE, ZINC OXIDE FLEUR DE VIE LLC 37ef4c1e-2183-a277-e063-6394a90ae2df 2025-06-19 Exact identifier application number: M020 Bioresist reinforcing effect face moisturizer SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE BEL STAR S A 99d7525d-b636-7f8e-e053-2a95a90a2080 2025-06-19 Warnings Exact identifier application number: M020 Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude Translucide OCTINOXATE, ZINC OXIDE BEL STAR S A c4d56723-3953-fb8e-e053-2a95a90a69d3 2025-06-19 Warnings Exact identifier application number: M020 SPF 50 Daily UV Defense Broad Spectrum Sunscreen OCTINOXATE, ZINC OXIDE Vi Medical Products, INC 2d814f8a-23b5-209f-e063-6394a90a5091 2025-06-19 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETICS BY RIKI LLC 37f2c5ed-c2f5-e569-e063-6294a90a15b1 2025-06-19 Exact identifier application number: M020 Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude Caramel OCTINOXATE, ZINC OXIDE BEL STAR S A c4f95c1b-acbe-4bb7-e053-2995a90a9120 2025-06-19 Warnings Exact identifier application number: M020 LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 ALMENDRA 230-N OCTINOXATE, ZINC OXIDE Bel Star S.A. d22fde8a-ba14-2cc7-e053-2a95a90a0e53 2025-06-19 Warnings Exact identifier application number: M020 Correct and Protect Serum Broad Spectrum SPF 45 ZINC OXIDE Murad, LLC dba6e01b-a8ec-4812-bbe0-e418bb067032 2025-06-19 Warnings Exact identifier application number: M020 Truffoire Truffle Brightening OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. e3068ecf-0bee-4e8a-a439-4bb707a2845d 2025-06-18 Warnings Exact identifier application number: M020 Aveeno Kids Continuous Protection Sensitive Skin Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 383de98b-65b5-4398-a876-87367dc01d0b 2025-06-18 Warnings Exact identifier application number: M020 CB Multi-Active Moisturizer with SPF 30 OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. d9557a6c-78e9-4b01-8a4b-e0eceb511c4e 2025-06-18 Warnings Exact identifier application number: M020 1000 Roses CC Color plus Correct Sheer Beige SPF 30 ZINC OXIDE Andalou naturals 2e7f3570-f710-41dd-95a0-7c0613b317a2 2025-06-17 Warnings Exact identifier application number: M020 Skin by Scottie Beach Mode Mineral Sunscreen Roll-On SPF 30 TITANIUM DIOXIDE, ZINC OXIDE SKIN CARE BY SCOTTIE LLC a9afa58c-f438-48c6-bd30-eda41334df74 2025-06-16 Warnings Exact identifier application number: M020 Wellage Real Hyaluronic Watery Glow Sun Screen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Hugel, Inc. 37aa2f7b-afa4-5cc9-e063-6294a90ae741 2025-06-16 Warnings Exact identifier application number: M020 Dermaka Sunscreen SPF 42, Tinted TITANIUM DIOXIDE, ZINC OXIDE DERMAKA SKIN PRODUCTS 9a967cd1-9eec-4255-b14b-ac2e33e4dbf0 2025-06-16 Warnings Exact identifier application number: M020 Elizabeth Arden Eight Hour Hydraplay SPF 40 OCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENE Revlon Consumer Products Corp 2cc74177-0f62-106e-e063-6394a90a6e28 2025-06-16 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