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 190 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sun Bum 30 Mineral Sunscreen Lip Balm ZINC OXIDE Sun Bum, LLC 3cbfba65-5702-50b5-e063-6394a90a409d 2025-08-19 Warnings Exact identifier application number: M020 Sun Bum Signature High Performance Mineral Sunscreen Face Stick Tinted 50 ZINC OXIDE Sun Bum, LLC 324e8ddb-89d2-08ca-e063-6294a90ab6c1 2025-08-19 Warnings Exact identifier application number: M020 Sun Bum 70 Premium Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3b02811d-dc66-fc6f-e063-6294a90aefc8 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Kids 50 Clear Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3b058b74-27d0-8f8a-e063-6294a90aa02c 2025-08-18 Warnings Exact identifier application number: M020 PLAY Mineral Stick SPF 50 with Olive Fruit Extract ZINC OXIDE Supergoop LLC 3ca7e1ed-7cc7-76b0-e063-6394a90ade93 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Mineral 30 Sunscreen 6 OZ ZINC OXIDE Sun Bum, LLC 3b91a7e3-ce52-6aa0-e063-6394a90a15e7 2025-08-18 Warnings Exact identifier application number: M020 CoTZ Kids ZINC OXIDE Fallien Cosmeceuticals, LTD. 3ca8742f-67cb-a25c-e063-6394a90a4638 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum 30 Premium Moisturizing Sunscreen 8 OZ AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3b154009-9c6f-eadf-e063-6394a90ae424 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Kids 50 Clear Sunscreen 6 OZ AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3b162348-0222-490e-e063-6394a90ad494 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum 50 Premium Moisturizing Sunscreen 1.75 OZ AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3b169860-66bc-dd02-e063-6294a90a7974 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum 30 Mineral Sunscreen Face 1.7 OZ TITANIUM DIOXIDE, ZINC OXIDE Sun Bum, LLC 3b1729c5-d8ca-94c7-e063-6394a90a67a5 2025-08-18 Warnings Exact identifier application number: M020 CoTZ Kids ZINC OXIDE Fallien Cosmeceuticals, LTD. 3ca914e2-cd53-42bf-e063-6294a90a7082 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Daily Mineral Sunscreen Moisturizer Broad Spectrum SPF 30 ZINC OXIDE Sun Bum, LLC 3b1a0596-b852-16be-e063-6394a90a3498 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Signature Clear High Performance Sunscreen Broad Spectrum SPF 50 1.5 OZ OCTISALATE, OCTOCRYLENE, ZINC OXIDE Sun Bum, LLC 3b29dbfc-0b92-eb0f-e063-6294a90a16e1 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum 30 Mineral Sunscreen 32 OZ ZINC OXIDE Sun Bum, LLC 3b2cb7cf-7e2c-0fd2-e063-6294a90a3b17 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Sunscreen Oil 50 5 OZ AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3b2b4ba0-3f89-0a04-e063-6294a90ac1c0 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Signature Sunscreen Premium Zinc Lip Balm Broad Spectrum SPF 30 ZINC OXIDE Sun Bum, LLC 3ca9e9d3-1c73-7bd6-e063-6394a90ad204 2025-08-18 Warnings Exact identifier application number: M020 Ocean Potion Suncare Mineral 50 Essential Scent of Sunshine Zinc Oxide Continuous Sunscreen ZINC OXIDE GNL BRANDS INTERNATIONAL, LLC 3caaea85-0dfe-6f69-e063-6294a90a7d4a 2025-08-18 Warnings Exact identifier application number: M020 PLAY Lip Shield SPF 30 - Mint AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop LLC 3cab1a7d-6226-9eba-e063-6294a90a8c4d 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Broad Spectrum SPF 30 5 OZ AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3cad0757-3155-c716-e063-6294a90ad7a9 2025-08-18 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