FDA.reportPublic FDA data

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
SOI2LOH54ZInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
15FIX9V2JPInternal 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 124 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Matte Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC3751544d-e093-3d19-e063-6394a90aefc32025-12-15Exact identifier
application number: M020
Lip CrackTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37edc05c-82c3-90fe-e063-6294a90aa6012025-12-15Exact identifier
application number: M020
Restore And ReplenishZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ed8525-6ae4-4e86-e063-6294a90afeb82025-12-15Exact identifier
application number: M020
Sunshade Daily Sun DefenseTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ee77dc-a96a-5efa-e063-6394a90affda2025-12-15Exact identifier
application number: M020
Sunshade Mineral SunscreenZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37df21f1-f36f-df43-e063-6294a90aea6f2025-12-15Exact identifier
application number: M020
Tinted Moisturizing Mineral SunscreenZINC OXIDEEDIT EUROSPA, LLC3751861d-3f3b-2ebd-e063-6294a90af8982025-12-15Exact identifier
application number: M020
Non Tinted Moisturizing Mineral SunscreenZINC OXIDEEDIT EUROSPA, LLC3751e278-b8b2-7bf4-e063-6394a90a42902025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC37521c60-2fee-861e-e063-6294a90ad69a2025-12-15Exact identifier
application number: M020
MATTE Non Tinted Mineral SunscreenZINC OXIDEAllure Esthetics3725d947-b1fa-3b50-e063-6394a90adf102025-12-15Exact identifier
application number: M020
GLOW Tinted Mineral SunscreenZINC OXIDEAllure Esthetics37257bb2-d91d-6ff8-e063-6294a90a01b62025-12-15Exact identifier
application number: M020
Daily RestoreZINC OXIDETYRLIN ENTERPRISES, INC.35ce7133-badb-1bc4-e063-6294a90a74782025-12-15Exact identifier
application number: M020
20Percent Zinc Oxide SunscreenZINC OXIDEMinder Day Spa, Inc.35bee5f9-68d6-6302-e063-6394a90ada882025-12-15Exact identifier
application number: M020
20Percent Zinc Oxide SunscreenZINC OXIDEMinder Day Spa, Inc.35bfd54a-d7b7-f1a7-e063-6294a90a039b2025-12-15Exact identifier
application number: M020
AM RESTOREZINC OXIDEMinder Day Spa, Inc.35c03804-04e9-3d54-e063-6294a90a34072025-12-15Exact identifier
application number: M020
Deflectin Tinted Mineral SunscreenZINC OXIDEAEON AESTHETICS LLC35d14660-8900-2cb0-e063-6394a90a317d2025-12-15Exact identifier
application number: M020
Mineral Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf36c1-50c9-e848-e063-6294a90a66582025-12-15Exact identifier
application number: M020
Flash Invisible StickTITANIUM DIOXIDE, ZINC OXIDEAEON AESTHETICS LLC35d2489e-4978-4fc3-e063-6294a90adfcc2025-12-15Exact identifier
application number: M020
AM RESTOREZINC OXIDEMinder Day Spa, Inc.35c010ad-e25d-f197-e063-6294a90a0efb2025-12-15Exact identifier
application number: M020
Flash Tinted StickTITANIUM DIOXIDE, ZINC OXIDEAEON AESTHETICS LLC35d28590-e746-7996-e063-6294a90ac7d82025-12-15Exact identifier
application number: M020
Mineral Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf03f4-200a-5643-e063-6394a90a9e022025-12-15Exact 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