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 110 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DAY DEFENSE TINTEDTITANIUM DIOXIDE, ZINC OXIDETHE SKIN CARE SOURCE, INC.36ad4442-e45f-90e2-e063-6294a90aeef52025-12-17Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d8b849-cf73-e008-e063-6394a90a410a2025-12-17Exact identifier
application number: M020
TINTED RESTORATIVE MOISTURIZERZINC OXIDESKINERGIX LLC3636adf0-c3bd-7422-e063-6394a90aaccc2025-12-17Exact identifier
application number: M020
Premier ZincZINC OXIDEENSO SKINCARE & WELLNESS LLC3bb378c8-14b0-aa13-e063-6294a90a4db32025-12-17WarningsExact identifier
application number: M020
Protect and RenewZINC OXIDEENSO SKINCARE & WELLNESS LLC3bb479ed-1153-8e80-e063-6294a90a29372025-12-17WarningsExact identifier
application number: M020
Flawless FinishTITANIUM DIOXIDE, ZINC OXIDEENSO SKINCARE & WELLNESS LLC3b8df7ce-e5ce-aaf8-e063-6394a90afdae2025-12-17WarningsExact identifier
application number: M020
Shield Mineral Sunscreen TintedZINC OXIDESMOOTHE LLC369b9d76-f6c3-e25f-e063-6294a90adaf32025-12-17Exact identifier
application number: M020
Shield Mineral Sunscreen Non TintedZINC OXIDESMOOTHE LLC369bc20d-7192-7c0a-e063-6294a90a3dfe2025-12-17Exact identifier
application number: M020
Lip BalmTITANIUM DIOXIDE, ZINC OXIDEPATRICIA SOLIS MAKEUP ARTIST, LLC369d63a9-b9a9-9530-e063-6394a90ac8ef2025-12-17Exact identifier
application number: M020
Matte TintTITANIUM DIOXIDE, ZINC OXIDEPATRICIA SOLIS MAKEUP ARTIST, LLC369ced69-59b4-0f3c-e063-6294a90a582f2025-12-17Exact identifier
application number: M020
Hydra TintZINC OXIDEPATRICIA SOLIS MAKEUP ARTIST, LLC369d4e7a-8356-8f15-e063-6394a90acca82025-12-17Exact identifier
application number: M020
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b0ac77-13d8-4259-e063-6394a90a893b2025-12-17Exact identifier
application number: M020
Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b000e3-2516-932c-e063-6294a90a0e412025-12-17Exact identifier
application number: M020
Moisturizing Mineral Sunscreen TintedZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b12dbc-5edc-aad1-e063-6394a90a42ea2025-12-17Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b1a6c8-b4ff-089a-e063-6394a90a24692025-12-17Exact identifier
application number: M020
Badger SPF 40 Tinted Mineral FaceZINC OXIDEW.S. Badger Company, Inc.4628c04f-b7a6-b3fe-e063-6294a90a16752025-12-17WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 50(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc0a5a4d0e-8ab2-3d79-e063-6394a90a70062025-12-17WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 50(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 5%, OCTISALATE 10%, OCTOCRYLENE 5%Beiersdorf Inc0a5a42a3-6fe4-2980-e063-6394a90a54fe2025-12-17WarningsExact identifier
application number: M020
Coppertone Glow Suncreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdord Incb65c117d-f200-bb22-e053-2995a90ab71d2025-12-17WarningsExact identifier
application number: M020
Covergirl Clean Fresh Tinted Lip Balm Glowing Protection SPF 15 Mineral Sunscreen - All shadesZINC OXIDE AND TITANIUM DIOXIDENoxell2cdbeb73-b805-f144-e063-6294a90a088d2025-12-17WarningsExact 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