FDA.reportPublic FDA data

AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 15C

Product NDC
67225-5203
11-digit product format
672255203
Labeler code
67225
Product ID
67225-5203_48e0cf3f-b8f5-64c0-e063-6394a90a2c51
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
2025-08-13
Substance
OCTOCRYLENE; TITANIUM DIOXIDE; OCTINOXATE
Active strength
.42; .7186; .91 g/14g; g/14g; g/14g
NDC exclude flag
No
Listing certified through
2027-12-31
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 15C
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE.42 g/14g
TITANIUM DIOXIDE.7186 g/14g
OCTINOXATE.91 g/14g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
15FIX9V2JPInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6b27df44-c441-4ae8-a1b0-a9cf2fff6f21Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67225-5203-1AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 15C14 g in 1 CASECREAM143
67225-5203-2AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 15C1 in 1 PACKAGECREAM13
67225-5203-3AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 15C2 in 1 PACKAGECREAM23

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 109 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bella Blue Skin Care Tinted SunscreenZINC OXIDEBELLA BLU STUDIOS INC3f663fe5-fdfe-d793-e063-6394a90a4f0b2025-12-17WarningsExact identifier
application number: M020
Tinted Daily Mineral ShieldZINC OXIDESIGNATURE MED SPA MT LLC3aadc018-edbb-033b-e063-6394a90afbe72025-12-17WarningsExact identifier
application number: M020
Non-Tinted Daily Mineral ShieldZINC OXIDESIGNATURE MED SPA MT LLC3ab0298d-b2d0-591e-e063-6394a90a31772025-12-17WarningsExact identifier
application number: M020
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY MINDY LLC3cce3120-748e-a7fd-e063-6394a90a4d512025-12-17WarningsExact identifier
application number: M020
Mineral Sunscreen 20percent Zinc OxideZINC OXIDEESTHETICS BY MINDY LLC3ccea6c0-8c27-6b26-e063-6294a90a09312025-12-17WarningsExact identifier
application number: M020
Non Tinted Mineral Sunscreen 20Percent Zinc OxideZINC OXIDEJKH Aesthetics LLC369c1d16-5980-e1dc-e063-6394a90a31042025-12-17Exact identifier
application number: M020
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY MINDY LLC3d5a2662-02e3-3a95-e063-6294a90a81202025-12-17WarningsExact identifier
application number: M020
Mineral Sunscreen 20percent Zinc OxideZINC OXIDEESTHETICS BY MINDY LLC3d5ab3f6-10b9-2a21-e063-6294a90a34282025-12-17WarningsExact identifier
application number: M020
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJKH Aesthetics LLC369ccb8f-d9b6-1fd2-e063-6394a90ace202025-12-17Exact identifier
application number: M020
Royal ScreenZINC OXIDEQUEENIES BEAUTY LLC364cafdd-fe86-cb23-e063-6394a90afb092025-12-17Exact identifier
application number: M020
Royal ScreenZINC OXIDEQUEENIES BEAUTY LLC364d2231-3db3-0a59-e063-6394a90a67772025-12-17Exact identifier
application number: M020
Mattifying Mineral SPF40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d4f6a7-1115-1efa-e063-6294a90a20c42025-12-17Exact identifier
application number: M020
Replenish SPF 40ZINC OXIDEELIZA ARAKELIAN36d69eb5-597d-14a0-e063-6394a90a0a492025-12-17Exact identifier
application number: M020
Mattifying Mineral SPF 40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d45700-fc41-ef54-e063-6394a90abcc32025-12-17Exact identifier
application number: M020
Gentle Mineral SPF 40 TintedZINC OXIDEELIZA ARAKELIAN36d66cde-1f90-32b5-e063-6294a90acb342025-12-17Exact identifier
application number: M020
Replenish SPF 40ZINC OXIDEELIZA ARAKELIAN36d7148b-b1c4-a6a9-e063-6294a90af92f2025-12-17Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d85902-fbd2-ba74-e063-6294a90acfc32025-12-17Exact identifier
application number: M020
DAY DEFENSETITANIUM DIOXIDE, ZINC OXIDETHE SKIN CARE SOURCE, INC.36ad1330-a8bf-e8f8-e063-6394a90acb022025-12-17Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d9a8f3-7760-57f3-e063-6394a90a1a1e2025-12-17Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d7a18b-5a12-84a9-e063-6394a90a7e382025-12-17Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67225-5203-16722552030114 g in 1 CASE14 gHistorical
67225-5203-2672255203021 CASE in 1 PACKAGE (67225-5203-2) / 14 g in 1 CASE (67225-5203-1) 1 case2025-08-13NoNoCurrent
67225-5203-3672255203032 CASE in 1 PACKAGE (67225-5203-3) / 14 g in 1 CASE (67225-5203-1) 2 case2026-01-21NoNoCurrent