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 268 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Banana Boat simply protect sensitive MINERAL ENRICHED SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50 HOMOSALATE,OCTISALATE,OCTOCRYLENE,ZINC OXIDE Edgewell Personal Care Brands, LLC 92fdea59-c19d-627a-e053-2995a90aabdc 2024-11-25 Warnings Exact identifier application number: M020 VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15 VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15 Bobbi Brown Professional Cosmetics Inc. eecb05ab-2048-6e8d-e053-2995a90a8280 2024-11-22 Warnings Exact identifier application number: M020 Covergirl Outlast Extreme Wear 3-in-1 Foundation 24 HR Full Coverage SPF 18 Octinoxate Sunscreen Liquid Foundation OCTINOXATE Noxell Corporation 258e8f05-295e-8e32-e063-6294a90a7548 2024-11-21 Warnings Exact identifier application number: M020 MILKY MINERAL SUN SERUM TITANIUM DIOXIDE AND ZINC OXIDE Synchronicity Spa, Inc. DBA Suntegrity 53834c89-b3b4-4e21-b9f6-19f95e78ba83 2024-11-21 Warnings Exact identifier application number: M020 NATURAL MOISTURIZING FACE SUNSCREEN and PRIMER ZINC OXIDE Synchronicity Spa, Inc. DBA Suntegrity 5996f9b2-18c1-4c8f-a0ab-eca180db61ad 2024-11-21 Warnings Exact identifier application number: M020 NATURAL MINERAL BODY SUNSCREEN ZINC OXIDE Synchronicity Spa, Inc. DBA Suntegrity dc5116d4-3a42-44d4-b41a-e88b5b16d111 2024-11-21 Warnings Exact identifier application number: M020 IMPECCABLE SKIN - IVORY ZINC OXIDE Synchronicity Spa, Inc. DBA Suntegrity 98a7896e-4b03-4184-ac2e-6b49e47c0bc4 2024-11-21 Warnings Exact identifier application number: M020 1177, 1178 Sunscreen 1177, 1178 SUNSCREEN Dynarex c3142ddb-74ea-a7d1-e053-2a95a90a26f3 2024-11-20 Warnings Exact identifier application number: M020 Covergirl Aquasmooth Broadspectrum SPF 20 All shades TITANIUM DIOXIDE Noxell Corporation 952ea869-581e-4503-9f21-a77d061a417d 2024-11-20 Warnings Exact identifier application number: M020 Covergirl TruBlend Base Business Everyday Defense Primer SPF 20 ENSULIZOLE NOXELL CORPORATION 8528aa01-fd4b-58a6-e053-2991aa0a3d6a 2024-11-20 Warnings Exact identifier application number: M020 Facial Skin Shield Broad Spectrum SPF50 Plus AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE AHAVA - Dead Sea Laboratories Ltd bb62c700-be07-4fe3-b007-425a5f760b30 2024-11-20 Warnings Exact identifier application number: M020 FOUNDATION LIGHT SPECTRUM OCTYL METHOXYCINNAMATE, ZINC OXIDE, TITANIUM DIOXIDE Guangzhou Bo win Trade Co., Ltd. 273ea785-241b-3e10-e063-6294a90a9fff 2024-11-19 Warnings Exact identifier application number: M020 FOUNDATION MEDIUM SPECTRUM OCTYL METHOXYCINNAMATE, ZINC OXIDE, TITANIUM DIOXIDE Guangzhou Bo win Trade Co., Ltd. 273f4d65-b245-c27a-e063-6394a90ade07 2024-11-19 Warnings Exact identifier application number: M020 Pool Bar London Not Just a Pretty Face Sunscreen SPF 50 ZINC OXIDE POOLBAR c081acef-9e1d-4aa6-b49c-c92fe28af2c7 2024-11-19 Warnings Exact identifier application number: M020 Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream SPF 30 Coconut and Vanilla Scented ZINC OXIDE POOLBAR 3a481521-e209-4c86-895f-2e7392b7c565 2024-11-19 Warnings Exact identifier application number: M020 Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream SPF 50 Coconut and Vanilla Scented ZINC OXIDE POOLBAR 1721023c-3321-4f0b-a053-6d0c657fa1b0 2024-11-19 Warnings Exact identifier application number: M020 Theraderm Platinum Protection Facial Sunscreen SPF 40 OCTOCRYLENE, OCTISALATE, ZINC OXIDE Therapon Inc 1fea6ad8-4d33-4f7c-800c-1bee644bd97f 2024-11-19 Warnings Exact identifier application number: M020 Fresh Monster Mineral Sunscreen ZINC OXIDE Blue Zebra Brands, Inc. 230cc36d-5163-f423-e063-6394a90a8124 2024-11-19 Warnings Exact identifier application number: M020 Covergirl Advanced Radiance Age Defying Makeup plus Sunscreen SPF 10 (All shades) OCTINOXATE AND TITANIUM DIOXIDE Noxell 356af30e-82c7-4e28-94bb-b536e74d01e1 2024-11-19 Warnings Exact identifier application number: M020 Covergirl plus Olay Simply Ageless Foundation plus Titanium Dioxide Sunscreen Broad Spectrum SPF 28 (All shades) TITANIUM DIOXIDE Noxell Corporation fab59bd6-4ef6-4626-9f75-edcd4088e643 2024-11-19 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