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 264 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior8a542b3c-c3c0-465a-9b24-6a62016656f32024-11-25WarningsExact identifier
application number: M020
CYZONE STUDIO LOOK MATTE FINISH BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 CLARO 110COCTINOXATE, ZINC OXIDEBEL STAR S A27c30645-dcef-bc31-e063-6394a90a13682024-11-25WarningsExact identifier
application number: M020
SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15OCTINOXATE AND TITANIUM DIOXIDEBobbi Brown Professional Cosmetics Inc.b669c36d-4c94-455d-8534-9c3bb024d6682024-11-25WarningsExact identifier
application number: M020
VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15Bobbi Brown Professional Cosmetics Inc.eecb05ab-2048-6e8d-e053-2995a90a82802024-11-22WarningsExact identifier
application number: M020
Covergirl Outlast Extreme Wear 3-in-1 Foundation 24 HR Full Coverage SPF 18 Octinoxate Sunscreen Liquid FoundationOCTINOXATENoxell Corporation258e8f05-295e-8e32-e063-6294a90a75482024-11-21WarningsExact identifier
application number: M020
MILKY MINERAL SUN SERUMTITANIUM DIOXIDE AND ZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity53834c89-b3b4-4e21-b9f6-19f95e78ba832024-11-21WarningsExact identifier
application number: M020
NATURAL MOISTURIZING FACE SUNSCREEN and PRIMERZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity5996f9b2-18c1-4c8f-a0ab-eca180db61ad2024-11-21WarningsExact identifier
application number: M020
NATURAL MINERAL BODY SUNSCREENZINC OXIDESynchronicity Spa, Inc. DBA Suntegritydc5116d4-3a42-44d4-b41a-e88b5b16d1112024-11-21WarningsExact identifier
application number: M020
IMPECCABLE SKIN - IVORYZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity98a7896e-4b03-4184-ac2e-6b49e47c0bc42024-11-21WarningsExact identifier
application number: M020
1177, 1178 Sunscreen1177, 1178 SUNSCREENDynarexc3142ddb-74ea-a7d1-e053-2a95a90a26f32024-11-20WarningsExact identifier
application number: M020
Covergirl Aquasmooth Broadspectrum SPF 20 All shadesTITANIUM DIOXIDENoxell Corporation952ea869-581e-4503-9f21-a77d061a417d2024-11-20WarningsExact identifier
application number: M020
Covergirl TruBlend Base Business Everyday Defense Primer SPF 20ENSULIZOLENOXELL CORPORATION8528aa01-fd4b-58a6-e053-2991aa0a3d6a2024-11-20WarningsExact identifier
application number: M020
Facial Skin Shield Broad Spectrum SPF50 PlusAVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltdbb62c700-be07-4fe3-b007-425a5f760b302024-11-20WarningsExact identifier
application number: M020
FOUNDATION LIGHT SPECTRUMOCTYL METHOXYCINNAMATE, ZINC OXIDE, TITANIUM DIOXIDEGuangzhou Bo win Trade Co., Ltd.273ea785-241b-3e10-e063-6294a90a9fff2024-11-19WarningsExact identifier
application number: M020
FOUNDATION MEDIUM SPECTRUMOCTYL METHOXYCINNAMATE, ZINC OXIDE, TITANIUM DIOXIDEGuangzhou Bo win Trade Co., Ltd.273f4d65-b245-c27a-e063-6394a90ade072024-11-19WarningsExact identifier
application number: M020
Pool Bar London Not Just a Pretty Face Sunscreen SPF 50ZINC OXIDEPOOLBARc081acef-9e1d-4aa6-b49c-c92fe28af2c72024-11-19WarningsExact identifier
application number: M020
Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream SPF 30 Coconut and Vanilla ScentedZINC OXIDEPOOLBAR3a481521-e209-4c86-895f-2e7392b7c5652024-11-19WarningsExact identifier
application number: M020
Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream SPF 50 Coconut and Vanilla ScentedZINC OXIDEPOOLBAR1721023c-3321-4f0b-a053-6d0c657fa1b02024-11-19WarningsExact identifier
application number: M020
Theraderm Platinum Protection Facial Sunscreen SPF 40OCTOCRYLENE, OCTISALATE, ZINC OXIDETherapon Inc1fea6ad8-4d33-4f7c-800c-1bee644bd97f2024-11-19WarningsExact identifier
application number: M020
Fresh Monster Mineral SunscreenZINC OXIDEBlue Zebra Brands, Inc.230cc36d-5163-f423-e063-6394a90a81242024-11-19WarningsExact 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