Home NDC 43419-404 IOPE AIR CUSHION Cover 21 Vanilla
Product NDC 43419-404
11-digit product format 434190404
Labeler code 43419
Product ID 43419-404_23f8ffed-66b2-4a97-e063-6394a90a7310
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE
Dosage form LOTION
Route TOPICAL
Labeler AMOREPACIFIC CORPORATION
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-12-26
Substance ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE
Active strength 2.94; 2.1; 1.245 g/30g; g/30g; g/30g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43419-404-34 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43419-404-34 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 43419-404-34 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 43419-404-34 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 43419-404-34 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 43419-404-34 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43419-404-34 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43419-404-34 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43419-404-34 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 43419-404-34 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43419-404-34 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43419-404-34 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base IOPE AIR CUSHION Cover 21 Vanilla
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 2.94 g/30g OCTINOXATE 2.1 g/30g TITANIUM DIOXIDE 1.245 g/30g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup 4Y5P7MUD51 Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43419-404-31 IOPE AIR CUSHION Cover 21 Vanilla 2 in 1 CARTON LOTION 2 9 43419-404-31 IOPE AIR CUSHION Cover 21 Vanilla 15 g in 1 CONTAINER LOTION 15 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43419-404 IOPE AIR CUSHION COVER 13 IVORY (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION IOPE AIR CUSHION COVER 21 VANILLA (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION IOPE AIR CUSHION COVER 23 BEIGE (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION IOPE AIR CUSHION COVER 31 WARM BEIGE (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION [AMOREPACIFIC CORPORATION] 9 Current NDC, Legacy NDC, 2 package rows 20241010_29d6cc8d-1469-479d-a15a-e78d4e22d4a2.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 39 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HYDRA SPF 34 HOMOSALATE, OCTYL SALICYLATE, AVOBENZONE Drmtlgy, LLC 31e41ed5-8498-4e2d-928a-c15ca99775e4 2026-04-21 Warnings Exact identifier application number: M020 FORGESKIN MINERAL TALLOW SUNSCREEN GUANGZHOU KANGLIXIN BIOTECHNOLOGY CO.,LTD 4fe913f4-b0be-dc53-e063-6294a90a363c 2026-04-20 Warnings Exact identifier application number: M020 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM AVOBENZONE, HOMOSALATE, OCTISALATE SEORIN COMPANY Co., Ltd. 228dcd68-aaba-0451-e063-6394a90a8ad0 2026-04-20 Warnings Exact identifier application number: M020 Biore Aqua Rich UV OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE KAO USA f900db18-5fe2-1d74-e053-6394a90a3ca2 2026-04-20 Warnings Exact identifier application number: M020 Biore UV Aqua Rich OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE KAO USA 2bc23bb5-86bb-7915-e063-6394a90a9d72 2026-04-20 Warnings Exact identifier application number: M020 ETUDE SunPrise Mild Airy Finish Sunstick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ETUDE CORPORATION 25abc744-5b62-acb4-e063-6394a90af110 2026-04-19 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7c399-b05e-2545-e053-2995a90ac611 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7c399-b060-2545-e053-2995a90ac611 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7d9f4-986f-70f7-e053-2a95a90a4f8a 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c81845-afcb-18ac-e053-2a95a90abdbe 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c83245-a40c-8f05-e053-2a95a90a0521 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c84047-fd3b-ea66-e053-2a95a90ae9aa 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c623aa-3846-b7f4-e053-2995a90aecb5 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c585ff-88de-e29c-e053-2a95a90af4d4 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c852de-4c36-6d93-e053-2995a90aff61 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c86288-bb22-03b1-e053-2995a90a3161 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c8742f-1060-48bc-e053-2995a90a31c2 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c4eedc-12a0-6418-e053-2a95a90a55e7 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c8849a-6624-6987-e053-2a95a90a4546 2026-04-18 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c8ac70-a8c8-2f07-e053-2a95a90a3d01 2026-04-18 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 43419-404-31 43419040431 2 CONTAINER in 1 CARTON (43419-404-31) / 15 g in 1 CONTAINER 2 container 2017-06-05 0000-00-00 No No Current