Home NDC 61354-088-01 Cream
Product NDC 61354-088
Requested package NDC 61354-088-01
11-digit product format 613540088
Labeler code 61354
Product ID 61354-088_e77748ac-2f7b-5fb9-e053-2a95a90a0eaf
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 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 61354-088-01 Cream 100 mg in 1 TUBE CREAM 100 1 61354-088-01 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 61354-088 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220831_e777457e-b29b-3b1c-e053-2a95a90a0fba.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 108 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mineral Sheer Stick ZINC OXIDE Supergoop, LLC 0beed72e-51df-d15a-e063-6394a90af559 2025-12-17 Warnings Exact identifier application number: M020 Sunscreen Lotion118ml ZINC OXIDE 12%,TITANIUM DIOXIDE 6%, HOMOSALATE 14%,OCTISALATE 5% Foshan Sugar Max Cosmetics CO.,Ltd 4620c41a-2188-00f5-e063-6394a90a613c 2025-12-17 Warnings Exact identifier application number: M020 Sunscreen Cream ZINC OXIDE 15%,TITANIUM DIOXIDE 6%,HOMOSALATE 5%,OCTISALATE 4% Foshan Sugar Max Cosmetics CO.,Ltd 46224dbe-a0fb-c242-e063-6394a90a2634 2025-12-17 Warnings Exact identifier application number: M020 CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 0N ENSULIZOLE, OCTISALATE Parfums Christian Dior 31141a45-54e2-4463-ab42-4df56d911650 2025-12-17 Warnings Exact identifier application number: M020 Perricone High Potency Face Finishing and Firming Moisturizer TITANIUM DIOXIDE, ZINC OXIDE THG Beauty USA LLC 2409cea1-7077-dc12-e063-6294a90a4558 2025-12-17 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Glow Advanced Skin and Body Care, LLC 3635a073-5484-f96c-e063-6394a90adef5 2025-12-17 Exact identifier application number: M020 Mineral Sunscreen Lip TITANIUM DIOXIDE, ZINC OXIDE Glow Advanced Skin and Body Care, LLC 36362dc7-31d7-f766-e063-6294a90a129b 2025-12-17 Exact identifier application number: M020 Mineral Sunscreen Non-Tinted ZINC OXIDE Glow Advanced Skin and Body Care, LLC 3635e45b-6978-ac69-e063-6294a90a22ac 2025-12-17 Exact identifier application number: M020 Prime and Protect TITANIUM DIOXIDE, ZINC OXIDE Shannon Cornelsen-Lewandowski 36480f7f-37e8-decd-e063-6394a90ada60 2025-12-17 Exact identifier application number: M020 Prime and Protect TITANIUM DIOXIDE, ZINC OXIDE Shannon Cornelsen-Lewandowski 364827bd-5781-eb53-e063-6394a90ab22f 2025-12-17 Exact identifier application number: M020 non-tinted face mineral sunscreen SPF40 TITANIUM DIOXIDE, ZINC OXIDE Lisa Nadler Skin Care and Waxing 3649bf1a-17c3-fe0b-e063-6294a90a13c0 2025-12-17 Exact identifier application number: M020 Tinted Mattifying Face Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Lisa Nadler Skin Care and Waxing 3649f634-8bcd-b3c1-e063-6394a90a49d9 2025-12-17 Exact identifier application number: M020 tinted face and body mineral sunscreen SPF40 ZINC OXIDE Lisa Nadler Skin Care and Waxing 364a1edd-56e1-55f0-e063-6294a90a45a6 2025-12-17 Exact identifier application number: M020 non-tinted face and body mineral sunscreen SPF40 ZINC OXIDE Lisa Nadler Skin Care and Waxing 364a8c8d-df84-e568-e063-6394a90aaff1 2025-12-17 Exact identifier application number: M020 tinted lip mineral sunscreen SPF45 TITANIUM DIOXIDE, ZINC OXIDE Lisa Nadler Skin Care and Waxing 364b023b-4a52-225a-e063-6394a90ad197 2025-12-17 Exact identifier application number: M020 ULTAMATTE PROTECTION SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE SKINFINITY 37efc466-17b8-9f7b-e063-6294a90a8c88 2025-12-17 Exact identifier application number: M020 ULTRA SILK PROTECTION SUNSCREEN ZINC OXIDE SKINFINITY 383ea760-d55e-a32a-e063-6294a90aa3d2 2025-12-17 Exact identifier application number: M020 Bella Blu Skin Care Non Tinted Sunscreen ZINC OXIDE BELLA BLU STUDIOS INC 3f67134c-88e8-8513-e063-6294a90aaf5a 2025-12-17 Warnings Exact identifier application number: M020 Bella Blu Skin Care Non Tinted Sunscreen ZINC OXIDE BELLA BLU STUDIOS INC 3f66d2ae-00e7-608c-e063-6294a90a49c6 2025-12-17 Warnings Exact identifier application number: M020 Bella Blue Skin Care Tinted Sunscreen ZINC OXIDE BELLA BLU STUDIOS INC 3f663fe5-fdfe-d793-e063-6394a90a4f0b 2025-12-17 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 61354-088-01 61354008801 1 TUBE in 1 CARTON (61354-088-01) > 100 mg in 1 TUBE 1 tube 2022-08-30 0000-00-00 No No Current