Home NDC 61354-082-01 Cream
Product NDC 61354-082
Requested package NDC 61354-082-01
11-digit product format 613540082
Labeler code 61354
Product ID 61354-082_e724e10c-4f05-b03d-e053-2a95a90a754c
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 2022-08-26
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 61354-082-01 Cream 1 in 1 CARTON LOTION 1 1 61354-082-01 Cream 100 mg in 1 TUBE LOTION 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-082 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220827_e724e098-f5c9-262a-e053-2995a90a2a02.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 168 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 55 Clubtray AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 0bd538e9-7716-9bc2-e063-6294a90a9a07 2025-11-06 Warnings Exact identifier application number: M020 Aveeno Positively Radiant Daily Moisturizer Sunscreen Broad Spectrum SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kenvue Brands LLC dd9ebc46-0fa4-5d96-e053-2995a90a7918 2025-11-06 Warnings Exact identifier application number: M020 Hawaiian Tropic Mineral Face Skin Nourishing Tinted Milk Coconut Oil SPF30 TITANIUM DIOXIDE, ZINC OXIDE Edgewell Personal Care Brands LLC eeb3c173-b280-76e4-e053-2995a90a0e79 2025-11-06 Warnings Exact identifier application number: M020 SPF 50 Sunscreen Stick ZINC OXIDE ELEEO BRANDS LLC 09cf0f04-961e-4430-91bb-224e7fed13ef 2025-11-06 Warnings Exact identifier application number: M020 Hawaiian Tropic Mineral Skin Nourishing Milk Coconut Oil SPF 50 TITANIUM DIOXIDE, ZINC OXIDE Edgewell Personal Care Brands LLC efcd52c2-4208-46a1-e053-2a95a90a857d 2025-11-06 Warnings Exact identifier application number: M020 Peachy Mineral Facial Sunscreen ZINC OXIDE Peachy Corp 42efead0-0e11-7270-e063-6394a90a4eb9 2025-11-06 Warnings Exact identifier application number: M020 Peachy Tinted Facial Sunscreen ZINC OXIDE Peachy Corp 42f0fb68-c0bf-cf98-e063-6294a90ab703 2025-11-06 Warnings Exact identifier application number: M020 Banana Boat AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Edgewell Personal Care Brands, LLC 764401f3-4219-6e9b-e053-2991aa0a3ed2 2025-11-06 Warnings Exact identifier application number: M020 Banana Boat Sport coolzone Clear Sunscreen Broad Spectrum SPF 30 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC ab7102ba-1020-3f51-e053-2995a90ae24d 2025-11-06 Warnings Exact identifier application number: M020 Banana Boat Sunscreen Lip Balm UVA/UVB Broad Spectrum SPF 45 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC c794592c-d24e-4530-e053-2995a90a7e4d 2025-11-06 Warnings Exact identifier application number: M020 Green Envee Radiance Sheer ZINC OXIDE Green Envee 42f1908f-2787-c4e5-e063-6294a90afcd0 2025-11-06 Warnings Exact identifier application number: M020 Indie Lee Daily Primer ZINC OXIDE America Exchange 38e5232b-7daf-7e61-e063-6394a90aa5b0 2025-11-06 Warnings Exact identifier application number: M020 Duette Untinted ZINC OXIDE Skin Theory Studios 3ce24b39-8bb1-1246-e063-6294a90a32d4 2025-11-06 Warnings Exact identifier application number: M020 Duette Tinted ZINC OXIDE Skin Theory Studios 3ce1d7cb-b37d-fb9f-e063-6394a90aaef3 2025-11-06 Warnings Exact identifier application number: M020 Truskin Broad Spectrum Mineral Sunscreen Facial Serum with Vitamin C and Aloe ZINC OXIDE Allure Labs 42f3999f-4163-fadc-e063-6294a90aacf3 2025-11-06 Warnings Exact identifier application number: M020 Melan RX ZINC OXIDE Melan RX f4bdf20c-b6bc-55f1-e053-2995a90ac308 2025-11-06 Warnings Exact identifier application number: M020 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA CAUTIVANTE EXOTIC) - PINK OCTINOXATE AND OXYBENZONE Ventura Corporation LTD e1eb77f1-d65c-4af8-a7d9-90f10570960f 2025-11-06 Warnings Exact identifier application number: M020 Ultraceuticals Ultra UV Protective Daily Moisturising ZINC OXIDE Ultraceuticals fc8a5c02-23b4-b4d8-e053-6294a90a55ea 2025-11-06 Warnings Exact identifier application number: M020 Vaihea Protect Clean SPF Drops ZINC OXIDE Vaihea Skincare LLC fe7e3145-a8e2-d14f-e053-6394a90abb5e 2025-11-06 Warnings Exact identifier application number: M020 Refy Skin Trio ZINC OXIDE Refy 3029a690-dbb0-ff15-e063-6394a90abdbe 2025-11-06 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 61354-082-01 61354008201 1 TUBE in 1 CARTON (61354-082-01) > 100 mg in 1 TUBE 1 tube 2022-08-26 0000-00-00 No No Current