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 261 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Lip Cream SPF 15 ZINC OXIDE COSMAX USA, CORPORATION 29227121-e579-8eea-e063-6394a90a302f 2024-12-13 Warnings Exact identifier application number: M020 BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,AND OXYBENZONE Bobbi Brown Professional Cosmetics Inc. 03372376-ef03-943d-e063-6394a90a52ee 2024-12-13 Warnings Exact identifier application number: M020 WEIGHTLESS SKIN FOUNDATION BROAD SPECTRUM SPF 15 OCTINOXATE, TITANIUM DIOXIDE Bobbi Brown Professional Cosmetics Inc. fbd04b66-738b-2762-e053-6394a90a8b72 2024-12-13 Warnings Exact identifier application number: M020 Mentholatum Natural Ice Cherry DIMETHICONE, OCTINOXATE, OCTISALATE The Mentholatum Company 33f43f14-8e0b-41b1-8ad0-5723d2a7bf19 2024-12-13 Warnings Exact identifier application number: M020 Absolutely Natural Broad Spectrum SPF 8 Sunscreen ZINC OXIDE Absolutely Natural a26217cf-22ab-4c39-980a-b73467e16b91 2024-12-13 Warnings Exact identifier application number: M020 Calming Primer SPF 20 TITANIUM DIOXIDE AND ZINC OXIDE Colorescience d681cdb5-307e-4a2a-8e1d-2b29131d48d0 2024-12-13 Warnings Exact identifier application number: M020 Absolutely Natural Broad Spectrum SPF 15 Sunscreen ZINC OXIDE Absolutely Natural 8084a3ee-fe31-4cb4-8d3c-e4035d29e561 2024-12-13 Warnings Exact identifier application number: M020 Mineral Corrector Palette SPF 20 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Colorescience ab70122f-bd68-4781-841f-dc83284e1403 2024-12-13 Warnings Exact identifier application number: M020 Neutrogena Healthy Skin Radiant Tinted Moisturizer Sunscreen Broad Spectrum SPF 25, Sheer Ivory 10 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC 0a0654cc-ad47-2167-e063-6294a90a52f4 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals Daily Sheer Mineral Sunscreen SPF 40 ZINC OXIDE, TITANIUM DIOXIDE Babo Botanicals, Inc. f8adda52-e909-1905-e053-6294a90a3c78 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals Swim and Sport Mineral Sunscreen SPF 30 ZINC OXIDE Babo Botanicals, Inc. f8b1ea3a-d62e-e00d-e053-6394a90a5689 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals Swim and Sport Mineral Sunscreen Balm SPF 50 ZINC OXIDE Babo Botanicals, Inc. f8b272f6-8726-de1d-e053-6294a90a7b1e 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals Super Shield Sport Sunscreen SPF 50 ZINC OXIDE Babo Botanicals, Inc. e3ca7840-4882-d605-e053-2a95a90af6ab 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals SPF 30 Daily Sheer Tinted Sunscreen - Natural Glow MINERAL SUNSCREEN Babo Botanicals, Inc. ab39d9f0-d869-6f33-e053-2995a90a08d4 2024-12-12 Warnings Exact identifier application number: M020 Alumier MD Sheer Hydration TITANIUM DIOXIDE, ZINC OXIDE Alumier Labs 88dedeb8-963f-5849-e053-2995a90aab72 2024-12-12 Warnings Exact identifier application number: M020 Everyday Coverage Tinted Sunscreen - Extra Light Tint ZINC OXIDE MV Advanced 7834c649-5f6d-b005-e053-2a91aa0a1084 2024-12-12 Warnings Exact identifier application number: M020 Everyday Coverage Tinted Sunscreen - Light Tint ZINC OXIDE MV Advanced 783649af-d746-84a3-e053-2991aa0a9e3d 2024-12-12 Warnings Exact identifier application number: M020 Everyday Coverage Tinted Sunscreen - Medium Tint ZINC OXIDE MV Advanced 783649af-d768-84a3-e053-2991aa0a9e3d 2024-12-12 Warnings Exact identifier application number: M020 Babo SPF 30 Clear Zinc Fragrance Free Sport MINERAL SUNSCREEN Babo Botanicals, Inc. b1a9f76d-0cef-29da-e053-2995a90af34c 2024-12-12 Warnings Exact identifier application number: M020 Babo Baby Face Mineral Sunscreen MINERAL SUNSCREEN Babo Botanicals, Inc. b131664d-1ad2-0a2f-e053-2995a90acbda 2024-12-12 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