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 SOI2LOH54Z Internal UNII lookup 4Y5P7MUD51 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 97 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sei Bella CC Brightening Creme Light OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% Melaleuca Inc. 6894b9d9-a5b5-4c98-e053-2991aa0a9ca2 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella CC Brightening Creme Fair OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% Melaleuca Inc. 6892952a-d032-30bf-e053-2a91aa0a3bba 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella CC Brightening Creme Medium Tan OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% Melaleuca Inc. 68a4e8b4-36cb-6306-e053-2a91aa0a6d25 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella CC Brightening Creme Medium OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% Melaleuca Inc. 68a4ed34-f492-67a6-e053-2a91aa0a0428 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Daily UV Defense Broad-Spectrum SPF 25 Sunscreen SUNSCREEN Melaleuca Inc. 1f1d1575-cf37-5d66-e063-6394a90ab2a3 2025-12-31 Warnings Exact identifier application number: M020 Eucerin Daily Hydration AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Beiersdorf Inc c9bb7d33-783b-4cbb-a130-91f92d4cc137 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Sheer to Light 140 N TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. a13e5326-73c3-9fa8-e053-2a95a90aae9d 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Sheer to Light 20 N TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. a13e3f45-8e6f-6a3f-e053-2995a90a17d2 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Deep 550 N TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e31a82-0cd0-5a1a-e053-2991aa0a33f8 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Light to Medium 200 N TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e2dfaa-d173-e6a9-e053-2a91aa0a4663 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Medium 300 W TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e2e541-c583-0f12-e053-2991aa0a4ab2 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Medium to Deep 500 W TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e30231-4fba-35d4-e053-2991aa0a33cb 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Medium 440 N TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e30255-5640-3b4a-e053-2991aa0ab3f7 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Medium to Deep 450 W TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e30255-564f-3b4a-e053-2991aa0ab3f7 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Medium 320 C TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e2e541-c596-0f12-e053-2991aa0a4ab2 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Light to Medium 160 N TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e20c57-7b30-4e96-e053-2991aa0aab3e 2025-12-31 Warnings Exact identifier application number: M020 Sun Shades Lip Balm Pina Colada AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% Melaleuca Inc. 16d0d2d2-b9c4-4491-8d8a-815843d342e8 2025-12-31 Warnings Exact identifier application number: M020 Sun Shades Lip Balm Mountain Mint AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% Melaleuca Inc. 326d9623-0e67-43bd-83f8-ee7dfa3bdbe8 2025-12-31 Warnings Exact identifier application number: M020 Sun Shades Lip Balm Vanilla Bean AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% Melaleuca Inc. 2037cc9d-b11b-47d6-8d65-c0f9decc8ba7 2025-12-31 Warnings Exact identifier application number: M020 Sun Shades Mineral Plus Sunscreen with Zinc Oxide OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5% Melaleuca Inc. 8886cbd0-ed2b-4a2b-a724-a0d4f12296c9 2025-12-31 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