FDA.reportPublic FDA data

AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W

Product NDC
67225-5232
11-digit product format
672255232
Labeler code
67225
Product ID
67225-5232_457c07a5-ae66-9cf7-e063-6294a90ac094
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
2022-10-20
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 23W
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
eb744367-f318-e1e2-e053-2a95a90a2cc4Available 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
67225-5232-2AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W2 in 1 PACKAGECREAM25
67225-5232-2AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W14 g in 1 CASECREAM145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67225-5232AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE) CREAM [AEKYUNG INDUSTRIAL CO., LTD.]4Current NDC, 2 package rows20250507_eb744367-f318-e1e2-e053-2a95a90a2cc4.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 206 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Orchidee Double Defense Skin ShieldOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.74b3c33f-5db5-460d-97be-fa495b6252492025-06-27WarningsExact identifier
application number: M020
GHOSTEDZINC OXIDESpoogea5b611c3-d4d3-461e-84d8-d04a29c749022025-06-26WarningsExact identifier
application number: M020
Dew MeZINC OXIDESpooge0c4b429b-7dd5-4929-95af-d02b6770f1212025-06-26WarningsExact identifier
application number: M020
Zinc FIVE-0 baby and kids mineral sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED38744f77-4845-eac4-e063-6294a90af6482025-06-26WarningsExact identifier
application number: M020
NYU Langone Health Lip BalmZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd38745b55-8da5-4627-e063-6394a90a24ca2025-06-26WarningsExact identifier
application number: M020
Active Skin Repair hydrating daily sunscreenZINC OXIDEInnovacyn, Inc.1eacdde1-f990-4962-92f1-3f41a8a3b1932025-06-26WarningsExact identifier
application number: M020
CheekyZINC OXIDESpooged377379a-a1be-4acf-9df5-2ff73fb5c83d2025-06-26WarningsExact identifier
application number: M020
TheOGZINC OXIDESpoogea2f781a8-eba8-48f5-8680-9235aae8a4ff2025-06-26WarningsExact identifier
application number: M020
Reef safe - Vitamin C sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f0763-74e9-3a71-e063-6394a90a46fb2025-06-25WarningsExact identifier
application number: M020
Reef safe - acne-prone sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f079c-5730-5111-e063-6394a90af2d82025-06-25WarningsExact identifier
application number: M020
Reef safe - Zinc Face sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f0f79-016f-71a7-e063-6394a90a92862025-06-25WarningsExact identifier
application number: M020
Reef safe - Baby zinc sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f320c-9144-78b8-e063-6394a90a2e9d2025-06-25WarningsExact identifier
application number: M020
Reef safe - Zinc Sport sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385ff227-1656-960a-e063-6294a90a913c2025-06-25WarningsExact identifier
application number: M020
Thermasun SPF50 Mineral Zinc facial sunscreenZINC OXIDE SUNSCREENVEGANIC SKN LIMITED386ecba0-2f7f-9178-e063-6394a90a44c42025-06-25WarningsExact identifier
application number: M020
Reefsun sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED386ec055-4ae7-9d2d-e063-6394a90a83c02025-06-25WarningsExact identifier
application number: M020
SR Active Sheer Zinc Face Stick SPF 5020.6% ZINC OXIDESkinresource.md, L.L.C.29928ab0-4467-57cb-e063-6394a90ac4d32025-06-25WarningsExact identifier
application number: M020
Sun Protection SPF 50AVOBENZONE 2.9%, HOMOSALATE 4.0%, OCTISALATE 4.9%, OCTOCRYLENE 9.5%Skinresource.md, L.L.C.2a0c3dd1-4bc0-6664-e063-6294a90af4b32025-06-25WarningsExact identifier
application number: M020
MELAO WHITENING SUNSCREENTITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd1aaf5942-ff13-ee07-e063-6394a90acd282025-06-25WarningsExact identifier
application number: M020
Blooskim BEEF TALLOW SUNSCREENNON-NANO ZINC OXIDEGuangzhou Haishi Biological Technology Co., Ltd.384903fa-e739-08b8-e063-6394a90a76532025-06-24WarningsExact identifier
application number: M020
Walgreens SPF 55 Sheer Face Mist SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf05b45e2-2fcd-631e-e053-2995a90ad3342025-06-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67225-5232-2672255232022 CASE in 1 PACKAGE (67225-5232-2) / 14 g in 1 CASE2 case2022-10-20NoNoCurrent