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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	43419-404		D	Discontinued by firm		2026-10-23
excluded package	package	43419-404	43419-404-34	D	Discontinued by firm		2026-10-23

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
SOI2LOH54Z	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
15FIX9V2JP	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
29d6cc8d-1469-479d-a15a-e78d4e22d4a2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99	Product name	1	20250618
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
2e254488-9fcb-41b3-a7c3-e2c9a3941b29	Product name	1	20200603
b4ff0805-126a-406d-9cae-fc34fd8e8889	Product name	1	20190711
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d676a241-be05-4740-b3ee-1a5f2ed422d2	Product name	4	20180615
dd8bd48f-20d6-43c7-b471-3ae872868afa	Product name	3	20180125
d41954ff-bc63-4b2c-aba0-9146707659d7	Product name	2	20151117
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

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 140 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N PACK OF 2	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	3483e4fa-883b-fb9c-e063-6394a90adcc4	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W PACK OF 2	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	3483dd31-417b-01ba-e063-6294a90a83a8	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C PACK OF 2	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	3483e998-6122-fb84-e063-6394a90a159f	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 28N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	c96e691a-99e1-4cb4-aebf-7444f4a6865f	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 33N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	ab1c8e9e-fd8f-473e-8930-625706e8e9d6	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	17073264-ec02-4801-841d-86778debd8c4	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 41N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	caee5c88-1907-41c1-987e-5bc544267dca	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 33W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	973b70f1-ee59-4dd9-aca3-432d721204ab	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	208fe03e-384b-4599-a4d0-a553fba306da	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	279258dd-b3fa-47be-8540-66bd9c879fc5	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 47N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	c2ad2a5e-f8fe-41b3-8b0f-9981c337ec5c	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	4206b607-5c26-4c9d-ade7-58c9740cdbe8	2025-12-09	Warnings	Exact identifier application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Medium	OCTOCRYLENE, ZINC OXIDE	L'BRI Health & Beauty	949a2796-717c-4820-ae09-2636e3dd6e3d	2025-12-09	Warnings	Exact identifier application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Medium Dark	OCTOCRYLENE, ZINC OXIDE	L'BRI Health & Beauty	f9bbc6d3-eb50-4953-8dba-732094b4c7c4	2025-12-09	Warnings	Exact identifier application number: M020
Safe Sea SPF 50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	NIDARIA TECHNOLOGY LTD	53df3126-1136-490a-b339-5876ce89499e	2025-12-09	Warnings	Exact identifier application number: M020
Safe Sea SPF 50 kids	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	NIDARIA TECHNOLOGY LTD	3fa04557-2bc1-4eb4-aed8-eacc79189613	2025-12-09	Warnings	Exact identifier application number: M020
Safe Sea SPF 40	OCTOCRYLENE, HOMOSALATE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE	NIDARIA TECHNOLOGY LTD	c900b88b-1de1-4df9-af84-d9001e1d4764	2025-12-09	Warnings	Exact identifier application number: M020
StriVectin ANTI-WRINKLE GLOWFECTOR SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	StriVectin Operating Company, Inc.	ed357e76-54a1-66bd-e053-2a95a90a1e2a	2025-12-09	Warnings	Exact identifier application number: M020
Non-tinted Physical Block Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Tucson Acne Clinic	30dd2f6b-5dcc-b081-e063-6394a90ae5f1	2025-12-09	Warnings	Exact identifier application number: M020
Tinted Physical Block Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Tucson Acne Clinic	30dc6e23-ecca-ed0b-e063-6294a90a7951	2025-12-09	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

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