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 205 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc.84fbbb01-bb16-41a6-a53a-6e85d515ca2c2025-07-08WarningsExact identifier
application number: M020
CeraVe Developed with Dermatologists Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80 Minutes Hybrid FormulaHOMOSALATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDEL'Oreal USA Products, Inc.cd69df67-5231-4a75-a9fb-a8669806a8922025-07-08WarningsExact identifier
application number: M020
Neutrogena Beach Defense Kids Sunscreen SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCfea50c84-0567-8547-e053-6394a90aafb72025-07-07WarningsExact identifier
application number: M020
24K Skin Tone Moisturizer SPF 30OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.b4f37f69-c61d-40c6-86cc-95d041b4d1b52025-07-07WarningsExact identifier
application number: M020
Vine Vera Resveratrol Cabernet Replenishing MoistureOCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.c48a7346-3971-4946-b527-a5549a98e2462025-07-07WarningsExact identifier
application number: M020
Lavelier Divine Day Defense Broad Spectrum SPF 30OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.1f33a93f-ae3f-4024-9d23-26b01eed17642025-07-03WarningsExact identifier
application number: M020
HIGHHEAT Sunscreen SPF 50 Performance For AthletesAVOBENZONE, OCTISALATE, OCTOCRYLENEDUGOUT ESSENTIALS LLC3b7cddb5-00d2-4998-8eec-5e5a7c5a60972025-07-03WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.39093b2d-3fbb-8378-e063-6294a90ac6d82025-07-03Exact identifier
application number: M020
Neutrogena Clear Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC09ccb37b-78ee-b510-e063-6294a90a48d52025-07-01WarningsExact identifier
application number: M020
First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEPort Jervis Laboratories, Inc.4b442fdf-a9cf-7e5a-e063-6394a90a9e1e2025-07-01WarningsExact identifier
application number: M020
Sincerely Yours Sunny Side Up Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDESincerely Yours Inc.4c9dfa22-70f7-83f6-e063-6394a90aa8c52025-07-01WarningsExact identifier
application number: M020
Nova Bright Skin SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONEInnovation Brands Inc.1c201147-7a54-41b5-bdf0-394e3d7efc0c2025-07-01WarningsExact identifier
application number: M020
Introstem Vitiscell Facial ShieldOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.65c28ed6-649d-41d9-b214-aab6ccb02dd52025-07-01WarningsExact identifier
application number: M020
Bath and Body Works SPF Tahiti IsleAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.38d049b4-557f-724a-e063-6394a90a19b32025-06-30WarningsExact identifier
application number: M020
Bath and Body Works SPF Tahiti IsleAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.2f74965f-3c84-0590-e063-6294a90af2672025-06-30WarningsExact identifier
application number: M020
Bath and Body Works SPF Tahiti IsleAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.38d0d165-e981-284a-e063-6294a90acace2025-06-30WarningsExact identifier
application number: M020
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERAINE DOUBLE REPAIR MATTE MOISTURIZER UV BROAD SPECTRUM SPF 30 FOR OILY, COMBINATION SKINAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inca3dc6195-3011-4e7f-b1b0-0c815b11ba8d2025-06-30WarningsExact identifier
application number: M020
Youth to the People Youthscreen Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE AND OCTISALATELOreal USA Products Inc5712df74-5201-474b-bbfd-703f3117bd9c2025-06-30WarningsExact identifier
application number: M020
BINDA Vitamin C and hyaluronic acid Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED38bff6d0-5690-3ee5-e063-6294a90a9faa2025-06-29WarningsExact identifier
application number: M020
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEToshiki Pigment Co., ltd.b7162a2f-07f1-6188-e053-2995a90a8a9c2025-06-27WarningsExact 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