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 74 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ANUA INVISIBLE MATTE FINISH SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE The Founders Inc. 4248deaf-ad55-a9b4-e063-6294a90a55cc 2026-01-19 Warnings Exact identifier application number: M020 ONSART Mineral Sunscreen ZINC OXIDE 24% Guangzhou Huixue Biotechnology Co., Ltd. 48c9d08d-9a91-7df5-e063-6294a90a1c4a 2026-01-19 Warnings Exact identifier application number: M020 Intense Moisture Day Cream AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE CVS Health 795d3546-f0dd-4b54-9807-9cdb3e626181 2026-01-19 Warnings Exact identifier application number: M020 CURESHIELD MANICURE SUNSCREEN ZINC OXIDE, TITANIUM DIOXIDE GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD 48b4fad7-073d-d983-e063-6394a90ae314 2026-01-18 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0CR Cool Fosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 65ff0448-17e6-42ce-989a-940794fcbd8c 2026-01-17 Warnings Exact identifier application number: M020 BenzoAzeline 10 BENZOYL PEROXIDE Noon Aesthetics M.R. Ltd 985efa19-bd91-45cd-a2a0-d71ec325e51c 2026-01-16 Warnings Exact identifier application number: M020 Prequel Lip Visor Berry SPF 30 PREQUEL LIP VISOR BERRY SPF 30 The Center Brands, LLC e4f3a0eb-4a8c-4145-92e4-979f03e3a511 2026-01-16 Warnings Exact identifier application number: M020 Prequel Lip Visor Blush SPF 30 PREQUEL LIP VISOR BLUSH SPF 30 The Center Brands, LLC bc681245-e158-4cfa-9718-7ec4cff0e60d 2026-01-16 Warnings Exact identifier application number: M020 Prequel Lip Visor Mahogany SPF 30 PREQUEL LIP VISOR MAHOGANY SPF 30 The Center Brands, LLC ea8dcd14-3c54-46a6-aabc-3655f051065b 2026-01-16 Warnings Exact identifier application number: M020 Prequel Lip Visor Nude SPF 30 PREQUEL LIP VISOR NUDE SPF 30 The Center Brands, LLC 03a7c77d-7b6e-4720-88f1-492ce57c7145 2026-01-16 Warnings Exact identifier application number: M020 Valmont Daily Veil Moisturizing Face Fluid Mineral Sunscreen SPF 30 ZINC OXIDE CVL Cosmetics North America Inc f3057856-1461-41d3-a5c4-9f12e3a4a0ee 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 04e9c4d8-1600-4ffc-8578-4ffb82b106f3 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 1d6f10b7-60b9-47f6-9dba-1dd0a7cf6f5d 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 1aae19da-1e73-41ed-91dc-0746ad311b87 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6,5W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 22d4452d-3798-48c6-a7a4-4af0f99b4ebd 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior d6800bb7-16ef-48f6-a09a-0422e64ad8bd 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior fb9cfd4f-a558-4df2-bbbf-b814ae19a135 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7,5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b9ddcda6-3d87-4197-a2c2-5b30016d32eb 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 25abef37-1726-491f-8a11-ac1a96378ed1 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 8N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b0e315b3-a322-4607-b212-bcadd5aa99bc 2026-01-16 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