Home NDC 61354-088 Cream
Product NDC 61354-088
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 · 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 34 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3CR Cool Rosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior d12905b6-97aa-429a-8800-23856fe31f06 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 43599d17-81f4-4c6e-b6bd-d1e700b668ee 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0.5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 116f09db-f859-40c5-8857-33503903ee76 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 480e5bf9-8e24-4335-a434-93255ceb640e 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1.5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 7057feab-20fe-4547-8223-0816904bcfd6 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1CR Cool Rosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 672a804d-ba8e-4c03-91fc-3edc0b12c627 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3.5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b656394d-a410-4f8c-a632-815a349fb17e 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6.5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 4d47292f-35f2-4e9f-a9d8-2df57cbe92cf 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 7N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 96258152-5255-4f04-9a35-c5a76b9c0520 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5df158da-3280-4ce6-a04c-370999343400 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2.5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior be60feb0-8c16-4ef6-a36f-423ed18e098c 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 2d7678b4-b082-4911-80a2-c019eb529414 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 9N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 00c9da7c-d4c7-49da-afa9-1fde93a81540 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 201acd8e-23c6-43fd-81dc-a814c3d8160b 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 8N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b24806b1-d9da-4373-b072-6d9a262ea365 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior c981ae5e-e7e8-484b-b682-fb96d501e03b 2026-05-06 Warnings Exact identifier application number: M020 Poth Clear Gel Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Poth LLC 1b0b6716-f4e1-4a3b-9f06-1c95f1f8a17a 2026-05-06 Warnings Exact identifier application number: M020 FORGE SKIN MINERAL TALLOW SUNSCREEN 30 SPF FORGE SKIN MINERAL TALLOW SUNSCREEN 30 SPF Horizons Ventures LLC 5127ac89-3dff-5966-e063-6394a90a11db 2026-05-06 Warnings Exact identifier application number: M020 PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDE Have & Be Co., Ltd. 4a7e868d-6310-6ee4-e063-6394a90aebce 2026-05-06 Warnings Exact identifier application number: M020 Vivaiodays Sunscreen with Turmeric ZINC OXIDE 5SENCO INC DBA VIVAIODAYS 5129e680-f485-9c66-e063-6394a90a0e7e 2026-05-06 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