SULWHASOO PERFECTING CUSHION NO. 15

Product NDC
43419-075
11-digit product format
434190075
Labeler code
43419
Product ID
43419-075_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
2027-06-30
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

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. 15

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE2.1 g/30g
TITANIUM DIOXIDE1.245 g/30g
ZINC OXIDE2.94 g/30g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8d420e4b-c778-3ed4-e053-2995a90a59a9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43419-075-31SULWHASOO PERFECTING CUSHION NO. 1515 g in 1 CONTAINERLOTION1510
43419-075-31SULWHASOO PERFECTING CUSHION NO. 152 in 1 CARTONLOTION210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43419-075SULWHASOO 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]9Current NDC, Legacy NDC, 2 package rows20241012_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 14 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UV RESTORE FACE SERUM SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA564b8070-ee59-0c24-e063-6294a90ad9a92026-07-10WarningsExact identifier
application number: M020
COCO-EVE COCONUT MILK BODY SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOSMAX USA564b80c2-16e0-fb5f-e063-6394a90a50d22026-07-10WarningsExact identifier
application number: M020
COCO EVE SUNNY HONEY HIGHLIGHTER BODY SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECOSMAX USA564b9b1f-3d5b-4349-e063-6294a90a3b772026-07-10WarningsExact identifier
application number: M020
NORWEX Lip Glaze Broad Spectrum SPF 30 HazelnutZINC OXIDECOSMAX USA564ba912-c44b-4940-e063-6294a90a28fa2026-07-10WarningsExact identifier
application number: M020
MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOSMAX USA564bbb5f-4000-390d-e063-6294a90a408d2026-07-10WarningsExact identifier
application number: M020
PEACH AND LILY SUN COVER MINERAL SUNSCREEN SPF 30ZINC OXIDECOSMAX USA564bb5f9-5ac5-548b-e063-6394a90a84622026-07-10WarningsExact identifier
application number: M020
ILLUSION LUMINOUS GLOW FOUNDATIONAVOBENZONE, HOMOSALATE, AND OCTISALATEKingdom Animalia, LLC DBA Hourglass Cosmeticscf6a7e1a-7bca-439c-808a-80262f095f842026-07-10WarningsExact identifier
application number: M020
Tula Skincare Protect and Glow Daily Facial Sunscreen Gel SPF 30AVOBENZONE, HOMOSALATE, AND OCTISALATEThe Procter & Gamble Manufacturing Company30a063fa-e537-a2c1-e063-6394a90a6a832026-07-09WarningsExact identifier
application number: M020
Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 15 SensitiveOCTINOXATE AND ZINC OXIDEThe Procter & Gamble Manufacturing Company3cb971e1-34f1-ee89-e063-6394a90a52a92026-07-09WarningsExact identifier
application number: M020
Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 30 SensitiveOCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDEThe Procter & Gamble Manufacturing Company3cb9de81-f05e-9697-e063-6394a90a69c52026-07-09WarningsExact identifier
application number: M020
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
application number: M020
Sunny C Sunscreen SPF 50SUNNY C SUNSCREENMIXIK, INC.4ed2a482-6c63-69f5-e063-6394a90ad3ee2026-07-08WarningsExact identifier
application number: M020
Ultra Violette Supreme Screen Broad Spectrum SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEGrace and Fire USA Inc.24389324-19db-7eb5-e063-6394a90ad7fb2026-07-08WarningsExact identifier
application number: M020
ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREENAVOBENZONE, HOMOSALATE, OCTINOXATE,OXYBENZONECOSMAX USA, CORPORATION562053d4-12bd-976e-e063-6394a90a59de2026-07-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
application number: M020
Sun Protection Mineral SPF 30ZINC OXIDEderma ebf6474a7-a21f-49cb-86e6-e5c40dbd34c32026-07-08WarningsExact identifier
application number: M020
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
application number: M020
Bath and Body Works SPF Pink DreamAVOBENZONE,HOMOSALATE,OCTISALATEBath & Body Works, Inc.560785f5-9126-12ba-e063-6294a90ac9462026-07-07WarningsExact identifier
application number: M020
Bath and Body Works SPF Sunkissed BerryAVOBENZONE,HOMOSALATE,OCTISALATEBath & Body Works, Inc.56078698-8655-12bd-e063-6294a90ad34c2026-07-07WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43419-075-31434190075312 CONTAINER in 1 CARTON (43419-075-31) / 15 g in 1 CONTAINER2 container2019-07-152027-06-30NoNoCurrent