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 174 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Good Defense Daily Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE Offspring Beauty Co. 2a462e60-6353-f791-e063-6294a90a62e3 2025-10-23 Warnings Exact identifier application number: M020 Skin Solution Multi-Serum Skin Tint SPF 40 ZINC OXIDE Offspring Beauty Co. 2d598f5d-d23f-6d54-e063-6294a90a778d 2025-10-23 Warnings Exact identifier application number: M020 AussieZinc Mineral Sunscreen Vegan and Organic Kids ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 36c7a1be-87e5-1f87-e063-6394a90ad876 2025-10-23 Warnings Exact identifier application number: M020 Aussiezinc Mineral Sunscreen SPF50 Baby ZINC OXIDE Veganic SKN Limited 16cc5178-e4c7-38eb-e063-6294a90a66de 2025-10-23 Warnings Exact identifier application number: M020 AussieZinc Mineral Sunscreen Vegan and Organic Everyday ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 36c9e96f-0299-095b-e063-6394a90a411d 2025-10-23 Warnings Exact identifier application number: M020 AussieZinc Mineral Sunscreen Vegan and Organic Anti-Aging - Light Tint ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 36c9f293-58c8-1a6f-e063-6394a90adc1f 2025-10-23 Warnings Exact identifier application number: M020 AussieZinc Mineral Sunscreen Vegan and Organic Hydrate and Nourish - Medium Tint ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 36ca1103-b9bf-2573-e063-6394a90acdc5 2025-10-23 Warnings Exact identifier application number: M020 AussieZinc Mineral Sunscreen Vegan and Organic Extra Sensitive ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 36ca5334-fd41-297f-e063-6394a90ac72e 2025-10-23 Warnings Exact identifier application number: M020 Mineral Sun Drops ZINC OXIDE Synchronicity Spa, Inc. DBA Suntegrity d8acda81-4430-42f8-be56-d28bb010e630 2025-10-22 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Latte OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS c34c1486-fa6c-485f-80b3-98e397b3dddb 2025-10-22 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 74c078ec-a371-4406-8d5e-a0baada3a1a6 2025-10-22 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Sandalwood OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 2765f345-eab2-4878-b1f1-f8e243083476 2025-10-22 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Toffee OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS d1181543-07ab-4a51-8b55-afc1a98293f6 2025-10-22 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm Beige OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS c7be3a7e-f031-4ec0-b9dc-41c025cd0066 2025-10-22 Warnings Exact identifier application number: M020 Powder TITANIUM DIOXIDE Oxygen Development LLC 41c0c262-21c3-b8e6-e063-6394a90a7c9c 2025-10-22 Warnings Exact identifier application number: M020 PHOTO FINISH INVISIBLE SPF 45 BROAD SPECTRUM SPF 45 PRIMER AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE SMASHBOX BEAUTY COSMETICS, INC 41c4e135-c6df-82d4-e063-6294a90a0ad3 2025-10-22 Warnings Exact identifier application number: M020 Miffy Sunny Defense SPF Stick HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE RBGROUP Co., Ltd 24802b17-c0ba-1075-e063-6394a90addd5 2025-10-21 Warnings Exact identifier application number: M020 Sunny Defense SPF Stick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE RBGROUP Co., Ltd 18632155-5feb-5759-e063-6294a90ab88c 2025-10-21 Warnings Exact identifier application number: M020 Paul Frank Sunny Defense SPF Stick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE RBGROUP Co., Ltd 26345203-3393-60ba-e063-6394a90a7e92 2025-10-21 Warnings Exact identifier application number: M020 Keith Haring Tone Blur Essence Sunscreen HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE RBGROUP Co., Ltd 1d578196-c785-9914-e063-6394a90a0533 2025-10-21 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