SULWHASOO PERFECTING CUSHION NO. 25

Product NDC: 43419-079
11-digit product format: 434190079
Labeler code: 43419
Product ID: 43419-079_440a35c1-f129-3c36-e063-6294a90a537d
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE
Dosage form: LOTION
Route: TOPICAL
Labeler: Amorepacific Corporation
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-07-15
Marketing end: 2027-03-31
Substance: OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 2.1; 1.245; 2.94 g/30g; g/30g; g/30g
NDC exclude flag: No
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	43419-079	43419-079-39	D	Discontinued by firm		2026-10-16

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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: SULWHASOO PERFECTING CUSHION NO. 25

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	2.1 g/30g
TITANIUM DIOXIDE	1.245 g/30g
ZINC OXIDE	2.94 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8d420e4b-c778-3ed4-e053-2995a90a59a9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43419-079-31	SULWHASOO PERFECTING CUSHION NO. 25	15 g in 1 CONTAINER	LOTION	15	10
43419-079-31	SULWHASOO PERFECTING CUSHION NO. 25	2 in 1 CARTON	LOTION	2	10
43419-079-39	SULWHASOO PERFECTING CUSHION NO. 25	15 g in 1 CONTAINER	LOTION	15	10
43419-079-39	SULWHASOO PERFECTING CUSHION NO. 25	2 in 1 CARTON	LOTION	2	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43419-079	SULWHASOO PERFECTING CUSHION NO. 21 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION SULWHASOO PERFECTING CUSHION NO. 27 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION SULWHASOO PERFECTING CUSHION NO. 31 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION SULWHASOO PERFECTING CUSHION NO. 33 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION SULWHASOO PERFECTING CUSHION NO. 15 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION SULWHASOO PERFECTING CUSHION NO. 17 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION SULWHASOO PERFECTING CUSHION NO. 23 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION SULWHASOO PERFECTING CUSHION NO. 37 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION SULWHASOO PERFECTING CUSHION NO. 11 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION SULWHASOO PERFECTING CUSHION NO. 25 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [AMOREPACIFIC CORPORATION]	9	Current NDC, Legacy NDC, 4 package rows	20241012_8d420e4b-c778-3ed4-e053-2995a90a59a9.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 66 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zealios Mineral SPF 30 Sunscreen	ZINC OXIDE	Personal Best Products Inc. dba Zealios	c421b00c-6536-4455-81f6-01686f8c2388	2026-02-03	Warnings	Exact identifier application number: M020
Zealios Sport Performance Ultralight SPF 50 Sunscreen	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Personal Best Products Inc. dba Zealios	020bd1b4-da50-4117-a4f3-b74aa4187396	2026-02-03	Warnings	Exact identifier application number: M020
Adrien Arpel Daily Defense Moisturizer SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Color Me Beautiful Inc	f65e1428-b79a-4126-862a-907ca17ee8f7	2026-02-02	Warnings	Exact identifier application number: M020
Flori Roberts Daily Defense Moisturizer SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Color Me Beautiful Inc	934d6b80-0cc3-4dcd-a25d-2191bd273618	2026-02-02	Warnings	Exact identifier application number: M020
Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN	HOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDE	Oracle Cosmetic Co., Ltd.	21424f78-f8d5-6a9b-e063-6294a90ab7dc	2026-02-02	Warnings	Exact identifier application number: M020
HAMPTON SUN SPF50 SUNSHIELD BODY GLOW	HOMOSALATE 10% OCTOCRYLENE 10% AVOBENZONE 3% OCTICALATE 5%	S&C Hampton Sun LLC	26190992-9463-47ae-86a5-0dbc05be8773	2026-02-02	Warnings	Exact identifier application number: M020
Sunscreen	AVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENE	Rite Aid Corporation	fe9146ec-b85d-43da-a391-377960f2c772	2026-02-02	Warnings, Adverse reactions	Exact identifier application number: M020
sheer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rite Aid Corporation	299a6690-9746-4410-a625-7636f0b4a754	2026-02-02	Warnings, Adverse reactions	Exact identifier application number: M020
Dr. C. Tuna Sun Stick SPF 50	AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENE	Farmasi US LLC	49dc6040-b400-7f5b-e063-6394a90ac7d7	2026-02-02	Warnings	Exact identifier application number: M020
Naturium Dew Glow Moisturizer Mineral SPF 50	ZINC OXIDE	e.l.f. Cosmetics, Inc	535f798f-d21d-92b2-e063-6294a90a72c7	2026-02-02	Warnings	Exact identifier application number: M020
Sol de Janiero Rio Radiance SPF 50 Body	ZINC OXIDE	Cosmetic Solutions LLC	2d54727d-5dcc-4792-85e8-1a2f21fe9e3d	2026-02-02	Warnings	Exact identifier application number: M020
Sky and Sol Face and Body Sunscreen Spf 50	ZINC OXIDE	Delta Ecommerce LLC	47d9dc66-328f-4cab-e063-6394a90a279d	2026-02-01	Warnings	Exact identifier application number: M020
e.l.f. Suntouchable Invisi-Stick Glitz SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f cosmetics,Inc.	4b801bb3-8930-7e04-e063-6294a90adaa1	2026-02-01	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR CLEAR	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Shiseido Americas Corporation	cedd7a3e-3334-437f-a283-482bcd0064ee	2026-01-30	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Shiseido Americas Corporation	bf16e8b5-b717-4255-a7da-9abe3d1ad8b4	2026-01-30	Warnings	Exact identifier application number: M020
Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rite Aid Corporation	372a8fba-b190-40fe-a1fc-fecf7f7afc35	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M020
ALOE UP MEDICATED LIP BALM SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Aloe Care International, LLC	859b6d3f-b1ca-4966-8f0c-f9afa0d5864c	2026-01-30	Warnings	Exact identifier application number: M020
ALOE UP SPORT NATURAL BALM SPF-15	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Aloe Care International, LLC	3de029ed-97f7-4cb3-a32e-d412bf3b5874	2026-01-30	Warnings	Exact identifier application number: M020
Reef safe unscented SPF 50 mineral sunscreen 01	TITANIUM DIOXIDE, ZINC OXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	49a77ad4-508c-9617-e063-6394a90a5623	2026-01-30	Warnings	Exact identifier application number: M020
JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetic Solutions LLC	d65ae1c9-dff5-4612-b8be-fa59bba03b81	2026-01-30	Warnings	Exact identifier application number: M020

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43419-079-31	43419007931	2 CONTAINER in 1 CARTON (43419-079-31) / 15 g in 1 CONTAINER	2 container	2019-07-15	2027-03-31	No	No	Current
43419-079-39	43419007939	2 CONTAINER in 1 CARTON (43419-079-39) > 15 g in 1 CONTAINER	2 container	2019-12-09	2021-12-02	No	No	Current