Home NDC 61354-082 Cream
Product NDC 61354-082
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 · 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 61354-082-01 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 259 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zoey naturals Broad Spectrum SPF 50 Fragrance Free Sunscreen ZINC OXIDE Absolutely Natural 6e05e060-a531-4c4a-b273-889407ec5704 2024-12-11 Warnings Exact identifier application number: M020 Peptide Lip Shine SPF30 Sunscreen ZINC OXIDE Colorescience, Inc. 98cdf19d-8b8a-4051-88bb-79160b2af39e 2024-12-11 Warnings Exact identifier application number: M020 Zoey naturals Broad Spectrum SPF 50Plus Fragrance Free Sunscreen ZINC OXIDE Absolutely Natural 082983a4-7b98-489d-8ac2-a185923b86ba 2024-12-11 Warnings Exact identifier application number: M020 Absolutely Natural Broad Spectrum SPF 50 Sunscreen ZINC OXIDE Absolutely Natural 89657538-904d-4908-ba7b-6f84706a8001 2024-12-11 Warnings Exact identifier application number: M020 SISLEYA Global Anti-Age Hand care SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE C.F.E.B. Sisley cddf11b1-a89b-4b54-b228-55ba8147f022 2024-12-10 Warnings Exact identifier application number: M020 SUNLEYA Age minimizing sun care SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE C.F.E.B. Sisley 67498d45-0871-4806-8854-81d3e50c4b90 2024-12-10 Warnings Exact identifier application number: M020 SUPER CREME SOLAIRE CORPS Body sun care SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE C.F.E.B. Sisley 1c774aa7-8963-4221-b4b0-b894bd1b941f 2024-12-10 Warnings Exact identifier application number: M020 Tinted Sunscreen Cream SPF 30 4-Deep Amber TITANIUM DIOXIDE, ZINC OXIDE C.F.E.B. - Sisley 5599922a-b020-477c-a44c-1db42ec5756a 2024-12-10 Warnings Exact identifier application number: M020 SUNLEYA Age minimizing sun care SPF 50 plus AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE C.F.E.B. Sisley 7c9fadaf-b961-4df0-89ae-87141b50b2c1 2024-12-10 Warnings Exact identifier application number: M020 Tinted Sunscreen SPF 30 1-Natural TITANIUM DIOXIDE, ZINC OXIDE C.F.E.B. - Sisley b3d53a10-2647-492a-a05f-b97c3f716aa8 2024-12-10 Warnings Exact identifier application number: M020 Tinted Sunscreen SPF 30 2-Golden TITANIUM DIOXIDE, ZINC OXIDE C.F.E.B. - Sisley 389cbce6-552c-4633-babd-7b672632f0b9 2024-12-10 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 28f08236-1f01-d759-e063-6294a90adcfa 2024-12-10 Warnings Exact identifier application number: M020 Blistex Five Star Lip Protection Broad Spectrum HOMOSALATE, OCTISALATE, AVOBENZONE, AND DIMETHICONE Blistex Inc. 47b57317-7df5-442e-a3a4-1d44fe278ac6 2024-12-10 Warnings Exact identifier application number: M020 AHAVA Brightening Broad Spectrum SPF 20 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE AHAVA - Dead Sea Laboratories Ltd 724bbb91-e273-4926-9ad6-a1657ffe4cd8 2024-12-10 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Stick Unscented SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0d83c576-5dfb-583a-e063-6294a90a2a28 2024-12-09 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral Sunscreen Face Stick Unscented SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0d833e3b-5330-3c5b-e063-6394a90a2ed2 2024-12-09 Warnings Exact identifier application number: M020 ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Stick Unscented SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0d9533ba-5606-4116-e063-6294a90ad3b1 2024-12-09 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral Sunscreen Stick Unscented SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0d82121d-1dc2-cd99-e063-6394a90aa766 2024-12-09 Warnings Exact identifier application number: M020 Attitude Kids Oatmeal sensitive mineral sunscreen unscented SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 310e66a2-8714-4016-87f4-81c1fef19ec9 2024-12-09 Warnings Exact identifier application number: M020 Attitude Oatmeal sensitive mineral sunscreen unscented SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude b6b8733d-6431-4ed2-9350-c63bb901c804 2024-12-09 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