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 155 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Centellian24 Madeca Derma Shield Vital Dewy Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTROCRYLENE 70541 44e0098c-170f-ca51-e063-6294a90aed20 2025-12-01 Warnings Exact identifier application number: M020 Centellian24 Madeca Derma Shield Vital Sun Essence AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 70541 44e194cd-ea61-71b3-e063-6394a90ac486 2025-12-01 Warnings Exact identifier application number: M020 Venture Performance Sun Protection Mineral Sunscreen SPF 50 ZINC OXIDE Venture Performance Inc 630fc5c2-a315-4e26-9bd9-5f8533d75908 2025-12-01 Warnings Exact identifier application number: M020 EMINENCE Red Currant Protective Moisturizer OCTINOXATE, ZINC OXIDE Eminence Organic Skin Care 7eca62af-6f70-44ec-879e-74712163c4e0 2025-12-01 Warnings Exact identifier application number: M020 CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Poreless Primer AVOBENZONE, OCTINOXATE, OCTISALATE AND OCTOCRYLENE Charlotte Tilbury Beauty Ltd. 2b215ecb-7c3a-63db-e063-6394a90aa88f 2025-12-01 Warnings Exact identifier application number: M020 P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE LIFE WITHCORPORATION Inc. 44ea9fb4-8e01-6969-e063-6294a90a6a94 2025-12-01 Warnings Exact identifier application number: M020 RoC Barrier Renew AM Moisturizer SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE RoC Skincare 020aa79f-4fd6-1ea1-e063-6394a90a4464 2025-12-01 Warnings Exact identifier application number: M020 ROC MULTI CORREXION - EVEN TONE AND LIFT - 5-In-1 Chest, Neck, and Face Cream Sunscreen - Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATA, OCTISALATE, OCTOCRYLENE Roc Skincare 2b3656d6-4b3a-9ef2-e063-6294a90acaa6 2025-12-01 Warnings Exact identifier application number: M020 UNCOMPLIKATED MAKEUP SETTING SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE Rare Beauty Brands Inc. 44ec0db5-4437-e4a3-e063-6294a90a9a00 2025-12-01 Warnings Exact identifier application number: M020 RoC Retinol Correxion Wrinkle Correct Daily Moisturizer SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE RoC Skincare 2888a198-116b-8441-e063-6394a90a0f95 2025-12-01 Warnings Exact identifier application number: M020 ReefSafe Very High Sun Protection sunscreen ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 44ec619f-ed3b-2fd3-e063-6294a90a858b 2025-12-01 Warnings Exact identifier application number: M020 Reef safe - Face and Body sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 38603298-e8da-e4c7-e063-6394a90aca3b 2025-12-01 Warnings Exact identifier application number: M020 ReefSafe Baby and Toddlers Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 44dd513e-ebaa-0d6a-e063-6394a90a78b7 2025-11-30 Warnings Exact identifier application number: M020 Safe4Kidz Natural Mineral Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 44ddc0ae-a977-3adf-e063-6294a90a0898 2025-11-30 Warnings Exact identifier application number: M020 Safe4Kidz Baby Zinc Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 44ddc4d8-3f3b-5d11-e063-6294a90ae88a 2025-11-30 Warnings Exact identifier application number: M020 Clarite Makeup Foundation for a Clearer Appearance SPF 30 170-N OCTINOXATE, ZINC OXIDE BEL STAR S A b56f5883-be57-e0e5-e053-2a95a90adb0c 2025-11-29 Warnings Exact identifier application number: M020 ATTITUDE Sunly Baby Mineral sunscreen Sprayer SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44a94a24-e292-41e6-e063-6394a90abe47 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral sunscreen Sprayer SPF 50 Tropical coco ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44a98951-6b25-6ee7-e063-6394a90a5433 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral sunscreen Sprayer SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44a9838e-06a6-5a98-e063-6394a90aaba1 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sensitive natural Mineral sunscreen Sprayer SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44a9d7c1-a4cf-d7bb-e063-6394a90a1f47 2025-11-28 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