Home NDC 61354-081 Cream
Product NDC 61354-081
11-digit product format 613540081
Labeler code 61354
Product ID 61354-081_e715df51-25f7-298a-e053-2a95a90a0464
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide
Dosage form LOTION
Route TOPICAL
Labeler Oxygen Development LLC
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-08-25
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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 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 61354-081-01 Cream 100 mg in 1 TUBE LOTION 100 1 61354-081-01 Cream 1 in 1 CARTON LOTION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-081 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220827_e715df51-25f6-298a-e053-2a95a90a0464.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 352 · 7,030 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Babo SPF 30 Clear Zinc Fragrance Free MINERAL SUNSCREEN Babo Botanicals, Inc. b3e40cb0-dbfd-955c-e053-2995a90af848 2024-12-12 Warnings Exact identifier application number: M020 DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 ZINC OXIDE BABOR Cosmetics America Corp 291ec801-ee15-06a4-e063-6294a90ab32b 2024-12-12 Warnings Exact identifier application number: M020 All Calm Clinical Redness Corrector SPF 50 TITANIUM DIOXIDE AND ZINC OXIDE Colorescience 68b95e94-3686-4d11-9952-ec86394376ee 2024-12-12 Warnings Exact identifier application number: M020 Method Men Face with Zinc Oxide Sunscreen ZINC OXIDE Method Products Inc. cce5f8e1-cf40-4524-af2b-1d49309e2809 2024-12-12 Warnings Exact identifier application number: M020 Sunforgettable Tint du Soleil Foundation SPF 30 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Colorescience 219e2ef4-e977-4527-8999-14b27d5a7a33 2024-12-12 Warnings Exact identifier application number: M020 Absolutely Natural Broad Spectrum SPF 50Plus Sunscreen ZINC OXIDE Absolutely Natural 4855c2c7-1516-4857-b103-2eb72a60d5d0 2024-12-11 Warnings Exact identifier application number: M020 Absolutely Natural Broad Spectrum SPF 30 Sunscreen ZINC OXIDE Absolutely Natural b6e8f361-fd31-4f21-9095-c5159a826175 2024-12-11 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 61354-081-01 61354008101 1 TUBE in 1 CARTON (61354-081-01) > 100 mg in 1 TUBE 1 tube 2022-08-25 0000-00-00 No No Current