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 336 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Artistry Exact Fit Longwearing Foundation Shade Tawny L3N1 TITANIUM DIOXIDE Amway Corp 706e1504-fad7-44fa-9030-f5b948e3e79b 2023-10-22 Warnings Exact identifier application number: M020 Artistry Exact Fit Longwearing Foundation Shade Cappuccino L5W1 TITANIUM DIOXIDE Amway Corp b785af89-1134-4fc6-8388-c47c52d153e0 2023-10-22 Warnings Exact identifier application number: M020 Artistry Exact Fit Longwearing Foundation Shade Natural L2N2 TITANIUM DIOXIDE Amway Corp db24e10a-6957-4ce7-8b03-572caacc647a 2023-10-22 Warnings Exact identifier application number: M020 Artistry Exact Fit Longwearing Foundation Shade Caramel L5N1 TITANIUM DIOXIDE Amway Corp e7d8616d-3e79-4b5e-b05b-fbb506c0203d 2023-10-22 Warnings Exact identifier application number: M020 Artistry Exact Fit Longwearing Foundation Shade Plush L3C1 TITANIUM DIOXIDE Amway Corp ff387c87-4ada-41c6-b62b-07a143213770 2023-10-22 Warnings Exact identifier application number: M020 Artistry Exact Fit Longwearing Foundation Shade Walnut L6N1 TITANIUM DIOXIDE Amway Corp 48c0bb8b-2f89-465e-9ae6-98690a2f877c 2023-10-22 Warnings Exact identifier application number: M020 Artistry Youth Xtend Lifting Smoothing Foundation Shade Buff L1W1 OCTINOXATE, OXYBENZONE Amway Corp 11a8cc16-33f1-43d1-9f35-aa0f6e70adf6 2023-10-22 Warnings Exact identifier application number: M020 CoreTex Sun X SPF 30 Thin AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE CoreTex Products Inc 980388b5-8314-3143-e053-2995a90a7288 2023-10-22 Warnings Exact identifier application number: M020 CoreTex Sun X SPF 30 Multipack New AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CoreTex Products f4ed9d7f-2d03-87d1-e053-2a95a90a3b4f 2023-10-22 Warnings Exact identifier application number: M020 Artistry Youth Xtend Lifting Smoothing Foundation Shade Chablis L1C1 OCTINOXATE, OXYBENZONE Amway Corp 8cdf7dcf-c2fa-4e41-8d56-c4f6cebe0a90 2023-10-22 Warnings Exact identifier application number: M020 Artistry Youth Xtend Lifting Smoothing Foundation Shade Mink L6W1 OCTINOXATE, OXYBENZONE Amway Corp 429044b1-f7b8-4d1e-8360-0feb380161dd 2023-10-22 Warnings Exact identifier application number: M020 Artistry Youth Xtend Lifting Smoothing Foundation Shade Cream L1W2 OCTINOXATE, OXYBENZONE Amway Corp e7e89303-f399-46c7-a029-c6d3d0a2dc4e 2023-10-22 Warnings Exact identifier application number: M020 Artistry Skin Nutrition BALANCING Matte Day AVOBENZONE, OCTISALATE, OCTOCRYLENE Access Business Group LLC d4a87153-7ef0-4365-ad91-dced9b1d8055 2023-10-21 Warnings Exact identifier application number: M020 Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen Light/Medium ENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE Amway Corp 830a748f-bb14-47f6-ab6f-48d8bd706321 2023-10-21 Warnings Exact identifier application number: M020 Artistry Skin Nutrition HYDRATING Day AVOBENZONE, OCTISALATE, OCTOCRYLENE Access Business Group LLC 06313228-7a79-48c5-8fd0-b210da6d037b 2023-10-21 Warnings Exact identifier application number: M020 Artistry Skin Nutrition RENEWING Reactivation Day SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE Access Business Group LLC bd4818b3-d5db-4812-96ec-1bd91aa1508b 2023-10-21 Warnings Exact identifier application number: M020 Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Med/Deep ENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE Amway Corp 20c432e2-4c63-485b-9dd5-2bc73b6f4285 2023-10-21 Warnings Exact identifier application number: M020 Artistry Ideal Radiance Illuminating CC SPF50 Broad Spectrum Sunscreen - Light ENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE Access Business Group LLC 070f9538-4b36-471a-aa06-6669e9ecfdf0 2023-10-21 Warnings Exact identifier application number: M020 Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen Medium ENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE Amway Corp 40a82d20-b84b-4ae8-818d-1f503ceef581 2023-10-21 Warnings Exact identifier application number: M020 Artistry Skin Nutrition RENEWING Reactivation Day Cream SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE Access Business Group LLC 4a0af0e9-04da-4b5f-a57a-967bef725789 2023-10-21 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