Home NDC 61354-088 Cream
Product NDC 61354-088
11-digit product format 613540088
Labeler code 61354
Product ID 61354-088_e77748ac-2f7b-5fb9-e053-2a95a90a0eaf
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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 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 61354-088-01 Cream 100 mg in 1 TUBE CREAM 100 1 61354-088-01 Cream 1 in 1 CARTON CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-088 CREAM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC] 1 Legacy NDC, 2 package rows 20220831_e777457e-b29b-3b1c-e053-2a95a90a0fba.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 9 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Continuous Correction Cream HOMOSALATE 10% OCTISALATE 4.9% OCTOCRYLENE 4% Baxter of California, LLC 14b05c8c-0398-2973-e063-6394a90a8a86 2026-07-31 Warnings Exact identifier application number: M020 Cover Creme TITANIUM DIOXIDE Baxter of California 31f5e8c4-523f-4596-e063-6294a90a6a12 2026-07-31 Warnings Exact identifier application number: M020 MELAO GHK-Cu PEPTIDE SUNSCREEN BUTYL METHOXYDIBENZOYLMETHANE,ETHYLHEXYL SALICYLATE,HOMOSALATE,OCTOCRYLENE Guangdong Aimu Biological Technology Co., Ltd 57a8c34a-d6c9-c03e-e063-6394a90a7af1 2026-07-29 Warnings Exact identifier application number: M020 BelleJoss BROAD SPECTRUM SPF 50 BROAD SPECTRUM SPF 50 Guangzhou Liyan Cosmetics Technology Co., Ltd. 57c07f29-2e23-d18a-e063-6394a90a1020 2026-07-29 Warnings Exact identifier application number: M020 BemeJolie BROAD SPECTRUM SPF 50 BROAD SPECTRUM SPF 50 Guangzhou Liyan Cosmetics Technology Co., Ltd. 57c27cea-bb0c-5d2d-e063-6394a90a1b48 2026-07-29 Warnings Exact identifier application number: M020 DeFlame ALLANTOIN Noon Aesthetics M.R. Ltd 2628bd73-0ca9-497b-bcd9-088444cd62be 2026-07-28 Warnings Exact identifier application number: M020 Native Mineral Suncare Broad Spectrum SPF 30 Unscented ZINC OXIDE The Procter & Gamble Manufacturing Company 3a89238b-d1ee-d7fa-e063-6294a90ae55f 2026-07-28 Warnings Exact identifier application number: M020 First Aid Beauty FAB Mineral Sunscreen Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company dfb1b42e-c821-1a41-e053-2995a90acf95 2026-07-28 Warnings Exact identifier application number: M020 HEB 50 Pumpkin Spice Latte Scent Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B. 579f3274-398e-7eab-e063-6394a90afe35 2026-07-27 Warnings Exact identifier application number: M020 LUXE COLOR FOUNDATION OCTINOXATE 7% ZINC OXIDE 5% Guangzhou Huixue Biotechnology Co., Ltd. 576c3496-702f-808c-e063-6394a90a53c3 2026-07-25 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25 Kit AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Xact Packing Limited 5759058d-e683-f3fc-e063-6394a90abc01 2026-07-24 Warnings Exact identifier application number: M020 No7 Future Renew Defense Shield SPF 50 AVOBENZONE, OCTINOXATE, OCTISALATE Xact Packing Limited 5758b79f-6386-bbea-e063-6394a90aeb34 2026-07-24 Warnings Exact identifier application number: M020 ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE BEL STAR S.A. 575fb2c3-e332-8a3b-e063-6394a90a9fd9 2026-07-24 Warnings Exact identifier application number: M020 SERVE AND PRIME SUNSCREEN BROAD SPECTRUM SPF 40 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE ESTEE LAUDER INC 575fc04a-794a-93e7-e063-6394a90a7e67 2026-07-24 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT ZINC OXIDE Younique, LLC f93d42a9-b655-4b75-a16d-b29f38f04efc 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT MEDIUM ZINC OXIDE Younique, LLC 82769819-b229-4864-9b3c-44f49a68a53a 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR ZINC OXIDE Younique, LLC ed700cae-8226-48d9-93ba-03154aa1cae5 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR LIGHT ZINC OXIDE Younique, LLC d728b89c-692f-485b-88c3-929b2f0350d5 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM ZINC OXIDE Younique, LLC a49dfff1-e9ec-4573-90b0-ef6a7226aa56 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM DARK ZINC OXIDE Younique, LLC cc576b63-caf4-491d-8d7f-027b1127133b 2026-07-23 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 61354-088-01 61354008801 1 TUBE in 1 CARTON (61354-088-01) > 100 mg in 1 TUBE 1 tube 2022-08-30 0000-00-00 No No Current