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		2026-10-21
excluded package	package	43419-404	43419-404-34	D	Discontinued by firm		2026-10-21

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.

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 89 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EVERYRAY SUNCARE SUNSHINE SERUM	EVERYRAY SUNCARE SUNSHINE SERUM	Guangzhou Fantesy Biotechnology Co.,Ltd	062be336-2af4-10e2-e063-6294a90a480a	2026-01-05	Warnings	Exact identifier application number: M020
sunscreen powder	SUNSCREEN POWDER	Guangzhou Fantesy Biotechnology Co.,Ltd	fae8ecaf-7a9c-902b-e053-6394a90a5f31	2026-01-05	Warnings	Exact identifier application number: M020
ORLASKIN HYDRATING SUNSCREEN	ORLASKIN HYDRATING SUNSCREEN	Guangzhou Fantesy Biotechnology Co.,Ltd	0808b0cd-2cfb-8554-e063-6294a90ad6c4	2026-01-05	Warnings	Exact identifier application number: M020
DALLAS JAMES SKINCARE CO. SPF 50 Sunscreen	DALLAS JAMES SKINCARE CO. SPF 50 SUNSCREEN	Guangzhou Fantesy Biotechnology Co.,Ltd	225faeec-4f96-e082-e063-6394a90a9a31	2026-01-05	Warnings	Exact identifier application number: M020
LING NEW YORK Save Face Broad Spectrum SPF 30	LING NEW YORK SAVE FACE BROAD SPECTRUM SPF 30	Guangzhou Fantesy Biotechnology Co.,Ltd	1dfa80bd-495a-18fb-e063-6394a90a4d0d	2026-01-05	Warnings	Exact identifier application number: M020
Sky and Sol Sunscreen SPF30	SKY AND SOL SUNSCREEN SPF30	Guangzhou Fantesy Biotechnology Co.,Ltd	1d917329-dea2-e792-e063-6294a90a0a0d	2026-01-05	Warnings	Exact identifier application number: M020
Sky and Sol Sunscreen SPF50	SKY AND SOL SUNSCREEN SPF50	Guangzhou Fantesy Biotechnology Co.,Ltd	1c699b06-c156-b0da-e063-6294a90a947d	2026-01-05	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	228fab45-e0d2-f219-e063-6294a90a1ef6	2026-01-05	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	228055ec-ff59-4412-e063-6394a90abe14	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORY	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	236bdb53-d7a5-43a2-8a0c-bce4a5522e26	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE	SHISEIDO AMERICAS CORPORATION	4bd99626-690b-49e8-8c42-a2e2dbca09bf	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE LONG-LASTING HYDRATING VEIL	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	f04ece6c-66b6-48e9-8f6b-e898a538ba00	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE RADIANT FOUNDATION N I10	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	05ffb157-5e28-4e94-866d-9e3371480d84	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE CONCEALER N 1	TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	eedf8065-8897-4773-9cbb-bab57d2dd04f	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE BRIGHTENING ENHANCER VEIL	OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	bb00d6d7-cc51-4fee-a0df-68bbd5bc50d6	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE THE FOUNDATION N I10 VERY LIGHT IVORY	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	beefe840-6f32-483b-8a37-2696adb8eea1	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE PROTECTIVE LIP TREATMENT SPF 25	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	addd9885-362c-4ce0-9a6e-759e71d8756c	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE PROTECTIVE FORTIFYING n	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE	SHISEIDO AMERICAS CORPORATION	65ca1240-6ee8-40c0-b62f-3597e0872c6e	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE CORRECTING VEIL n M	ENSULIZOLE, OCTINOXATE, AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	15a258a0-61c3-4419-bcdb-a8197d5ae46f	2026-01-05	Warnings	Exact identifier application number: M020
Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co.,Ltd.	098c0a9b-2b96-6be3-e063-6294a90a959a	2026-01-05	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