Home NDC 61354-086 Cream
Product NDC 61354-086
11-digit product format 613540086
Labeler code 61354
Product ID 61354-086_e776f37b-869c-5861-e053-2995a90a19f5
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide
Dosage form CREAM
Route TOPICAL
Labeler Oxygen Development LLC
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-08-30
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 61354-086-01 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 61354-086-01 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 61354-086-01 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 61354-086-01 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 61354-086-01 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 61354-086-01 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 61354-086-01 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 61354-086-01 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 61354-086-01 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 61354-086-01 Cream 1 in 1 CARTON CREAM 1 1 61354-086-01 Cream 100 mg in 1 TUBE CREAM 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-086 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220831_e776f37b-869b-5861-e053-2995a90a19f5.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 49 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hand Sunscreen Cream AVOBENZONE, OCTISALATE, OCTOCRYLENE Jiangsu Senwo Medical Technology Co., Ltd. 4e615757-76b1-8f34-e063-6394a90a280a 2026-04-01 Warnings Exact identifier application number: M020 All Good Mineral Sport Sunscreen Sunstick SPF 30 ZINC OXIDE Elemental Herbs, Inc. 4e67b76e-b791-4e26-e063-6294a90aa991 2026-04-01 Warnings Exact identifier application number: M020 All Good Coconut Mineral Sunscreen Sunstick SPF 30 ZINC OXIDE Elemental Herbs, Inc. 4e67e89b-a7be-a540-e063-6294a90a6d8f 2026-04-01 Warnings Exact identifier application number: M020 SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Shiseido Americas Corporation cad3a446-36a8-4146-81b5-1cc8d65abf14 2026-04-01 Warnings Exact identifier application number: M020 MENOKIN 30 SECONDS GLOW AND CLEAR Gel SUNSCREEN BRIGHT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Forest Avenue Co., Ltd. 8de4ec46-f60a-4c51-a16e-9140150e2162 2026-04-01 Warnings Exact identifier application number: M020 ChapStick Moisturizer Cool Mint SPF 15 SPF 15 LIP PROTECTANT Suave Brands Co., LLC 42f50497-ded1-6863-e063-6294a90a39c8 2026-03-31 Warnings Exact identifier application number: M020 Purito Sunday Adventure Sunscreen SPF 50, 50 mL AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Hinature bf16f535-97fc-4fd8-9310-8b6bbc82baae 2026-03-31 Warnings Exact identifier application number: M020 spf 50 mineral powder sunscreen TITANIUM DIOXIDE, ZINC OXIDE Smalls Brand LLC DBA Roe Wellness f8762dd1-0484-74ea-e053-6294a90ac112 2026-03-31 Warnings Exact identifier application number: M020 Badger SPF 30 Face Mineral Sunscreen ZINC OXIDE W.S. Badger Company, Inc. 14a9b605-f1f0-00e5-e063-6394a90a5a51 2026-03-31 Warnings Exact identifier application number: M020 Covergirl cgsmoothers BB Tinted Moisturizer Broad Spectrum SPF 21 (all shades) OCTINOXATE AND ZINC OXIDE Noxell Corporation 38bba282-b4f7-4374-8732-419400b1cc50 2026-03-31 Warnings Exact identifier application number: M020 SeranovaTM ULTRALIGHT SPF50 SERUM SERANOVATM ULTRALIGHT SPF50 SERUM Guangzhou Ariel Biotech Co., Ltd. 4e5d716d-2b2d-d42f-e063-6294a90a1e52 2026-03-31 Warnings Exact identifier application number: M020 ageLOC Tru Face Radiant Day AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE NSE Products, Inc. 3e9a0b39-4351-41df-81b2-88c1c15c0db2 2026-03-31 Warnings Exact identifier application number: M020 Sunright Solar Screen Mineral Face Sunscreen ZINC OXIDE NSE Products, Inc. 93a32040-3a47-4d6f-baa1-5a4595bef410 2026-03-31 Warnings Exact identifier application number: M020 Lancome Paris Renergie HPN 300 Peptide Sunscreen Broad Spectrum SPF 25 High-Performance Day AVOBENZONE, OCTISALATE, AND OCTOCRYLENE L'Oreal USA Products Inc 28f500e2-41d1-4747-8f26-3f6f8cc1b583 2026-03-30 Warnings Exact identifier application number: M020 Lancome Paris Renergie HPN 300 Peptide Sunscreen Broad Spectrum SPF 25 High-Performance Day AVOBENZONE, OCTISALATE, AND OCTOCRYLENE SICOS ET CIE dd448b7a-2554-4dfc-9eb3-ec3486ec6197 2026-03-30 Warnings Exact identifier application number: M020 ANUA MINERAL WEIGHTLESS FINISH SUNSCREEN ZINC OXIDE Thefounders 4e37d291-84fb-252a-e063-6294a90acd1f 2026-03-30 Warnings Exact identifier application number: M020 Beyond Glow Tinted Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE THE AVON COMPANY 4e43bea2-247d-fe11-e063-6294a90a33a3 2026-03-30 Warnings Exact identifier application number: M020 Abib Quick sunstick Protection bar HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE FOURCOMPANY CO., LTD. 1a2ab632-643f-1aa9-e063-6394a90a0c05 2026-03-30 Warnings Exact identifier application number: M020 ChapStick Classic Original Military SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 4514490b-f348-4526-e063-6294a90ad505 2026-03-30 Warnings Exact identifier application number: M020 ChapStick Moisturizer Black Cherry SPF 15 SPF 15 SKIN PROTECTANT Suave Brands Co., LLC 42f40978-51ca-f448-e063-6294a90acf31 2026-03-30 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 61354-086-01 61354008601 1 TUBE in 1 CARTON (61354-086-01) > 100 mg in 1 TUBE 1 tube 2022-08-30 0000-00-00 No No Current