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 345 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join H.E.B Solutions Sunscreen COCONUT PINEAPPLE SCENTED SPF 50 STICK H.E.B 29aef42c-f617-4c56-a166-8e1f0d6dbfd0 2021-07-09 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Warm Beige OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS 58465981-e84c-4eaf-b7d5-fad1666f63fc 2021-06-29 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Bamboo OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS b2259b27-e1a5-482c-8916-356c1ee9774a 2021-06-29 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Deeply Bronze OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS 199dde64-1dd3-4eb6-baef-261c97162f79 2021-06-29 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Creme OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS 753c34f2-3cb8-4df7-9aeb-ea926fb0279a 2021-06-29 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Dune OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS 745dd675-86ee-4acc-8333-4870e0a57c75 2021-06-29 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Latte OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS e66734e4-34e7-4674-bb98-bdca931a176d 2021-06-29 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Sand OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS bf78f7a7-93ca-425e-8571-175da6798e8e 2021-06-29 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Sepia OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS 418cdd4a-23f7-4181-b734-5ab7456494a2 2021-06-29 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Toffee OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS 50138c51-f424-4b07-b3eb-c0d31d8ecf16 2021-06-29 Warnings Exact identifier application number: M020 No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Cameo OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS 01a861b9-0ab6-4c4c-a407-428a64509a1c 2021-06-29 Warnings Exact identifier application number: M020 No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Birch OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS d5431d62-fded-4cdc-81a1-5b5e3eb92873 2021-06-29 Warnings Exact identifier application number: M020 No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Tawny OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS 52c3378f-6b99-42fa-900e-8a693864c615 2021-06-29 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen FACE SPF 70 LOTION H.E.B 73b49068-953b-496d-8ea9-404df7e79089 2021-01-19 Warnings Exact identifier application number: M020 Think Every Day Face Sunscreen SPF 30 ZINC OXIDE thinkOperations,LLC afed91dd-8544-4b4b-e053-2995a90a2d16 2020-09-22 Warnings Exact identifier application number: M020 THINKSPORT Kids sunscreen SPF 50 ZINC OXIDE thinkOperations,LLC 8b5a147d-4126-4fc5-a73b-fd5a19ccfd3d 2020-09-08 Warnings Exact identifier application number: M020 THINKBABY Baby Sunscreen SPF 50 ZINC OXIDE thinkOperations,LLC 820317d2-1803-4949-bddf-09521a5d1750 2020-09-08 Warnings Exact identifier application number: M020 THINKSPORT sunscreen SPF 50 ZINC OXIDE thinkOperations,LLC 6b9b3ea2-65e5-4a51-a6e6-c79f89e5ccea 2020-08-03 Warnings Exact identifier application number: M020 ESSENTIALS Face and Body Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Rodan & Fields dfc44a01-e8fd-43fc-b3cd-5cac17e4a5a3 2020-04-02 Warnings Exact identifier application number: M020 Thinksport Sunscreen SPF 18 ZINC OXIDE thinkOperations,LLC 9cd5010c-0b23-2888-e053-2995a90adb72 2020-01-23 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