FDA.reportPublic FDA data

AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31N

Product NDC
67225-5331
11-digit product format
672255331
Labeler code
67225
Product ID
67225-5331_457c1162-da39-d2c3-e063-6294a90ac268
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octocrylene, Titanium Dioxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Aekyung Industrial Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-11
Substance
OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE
Active strength
.91; .42; .7168 g/14g; g/14g; g/14g
NDC exclude flag
No
Listing certified through
2026-12-31
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
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31N
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE.91 g/14g
OCTOCRYLENE.42 g/14g
TITANIUM DIOXIDE.7168 g/14g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
5A68WGF6WMInternal 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
247afcae-855e-3f69-e063-6394a90a4231Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67225-5331-2AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31N2 in 1 PACKAGECREAM23
67225-5331-2AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31N14 g in 1 CASECREAM143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67225-5331AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31N (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE) CREAM [AEKYUNG INDUSTRIAL CO., LTD.]2Current NDC, 2 package rows20250510_247afcae-855e-3f69-e063-6394a90a4231.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 170 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vertra Pearl White Face Stick SPF 50PADIMATE O, TITANIUM DIOXIDEToshiki Pigment Co., ltd.b7163861-7084-5adf-e053-2995a90ae1992025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 8OCTINOXATE AND OXYBENZONETropical Seas, Inc.b5fa2883-998f-2128-e053-2995a90a5c842025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 15OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b557c9c5-6ea8-1d59-e053-2995a90aff682025-11-04WarningsExact identifier
application number: M020
Vertra Ehukai Beige Face Stick SPF 38TITANIUM DIOXIDEToshiki Pigment Co., ltd.b71619c4-a8ef-1dda-e053-2995a90aba502025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 45OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATETropical Seas, Inc.b4cafdf1-44e1-10c0-e053-2995a90ab3dc2025-11-04WarningsExact identifier
application number: M020
Reef Kids SPF 30 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.e226b07a-9f44-4b17-8f26-c86dcfa5dcda2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 50OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b4cc95f0-d684-5331-e053-2995a90a32952025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 20OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b55792e6-2ead-1fb1-e053-2995a90ac9152025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 8OCTINOXATE AND OXYBENZONETropical Seas, Inc.b5e68448-4131-1c6c-e053-2a95a90a014a2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 40ZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d204c38c-b5d1-3511-e053-2a95a90a9dc82025-11-04WarningsExact identifier
application number: M020
Expedition BackCountry SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e4e63c-3e51-0a78-e053-2a95a90abd872025-11-04WarningsExact identifier
application number: M020
Reef Babies SPF 50 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.8cd68b09-2578-4519-b00e-e83e0e4408152025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e44be7-3a46-34e2-e053-2a95a90a96602025-11-04WarningsExact identifier
application number: M020
Reef Kids SPF 30 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.005a9e7c-e392-4b9a-911f-d7586f7ae94e2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b559d349-2ffd-492c-e053-2995a90aab062025-11-04WarningsExact identifier
application number: M020
Land Shark Zinky SPF 36 Pink BeachZINC OXIDETropical Seas, Inc.d240e6c9-d053-9924-e053-2a95a90a855a2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 15OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e49c6f-477b-aafc-e053-2a95a90a982a2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b559e03b-f5d3-bd72-e053-2995a90a31ca2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30 Clear ZincZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d128269b-73fa-e5f3-e053-2995a90af1ed2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 50 SportOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e40a7c-b49d-cfc3-e053-2995a90ac27e2025-11-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67225-5331-2672255331022 CASE in 1 PACKAGE (67225-5331-2) / 14 g in 1 CASE2 case2024-10-11NoNoCurrent