FDA.reportPublic FDA data

AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMEL

Product NDC
67225-5231
11-digit product format
672255231
Labeler code
67225
Product ID
67225-5231_457bf229-f06e-22b6-e063-6394a90ac6b7
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Titanium dioxide, Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
Aekyung Industrial Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-22
Substance
TITANIUM DIOXIDE; OCTOCRYLENE; OCTINOXATE
Active strength
.7168; .42; .91 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 COVER PACT INTENSE COVER 29 CARAMEL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE.7168 g/14g
OCTOCRYLENE.42 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
15FIX9V2JPInternal UNII lookup
5A68WGF6WMInternal 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
11f1ad4c-af9a-c998-e063-6294a90a15dbAvailable 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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67225-5231-1AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMEL40 g in 1 TUBECREAM405
67225-5231-2AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMEL1 in 1 BOXCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67225-5231AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMEL (OCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENE) CREAM [AEKYUNG INDUSTRIAL CO., LTD.]4Current NDC, 2 package rows20250323_11f1ad4c-af9a-c998-e063-6294a90a15db.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 84 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Play Lip Balm with Acai Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC9f5b54c7-a424-6917-e053-2a95a90ac6272026-01-09WarningsExact identifier
application number: M020
Everyday Sunscreen with Sunflower Extract Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATESupergoop, LLC81b9fda2-bd55-1b90-e053-2991aa0a765a2026-01-09WarningsExact identifier
application number: M020
Play Lip Balm Broad Spectrum SPF 30 with MintAVOBENZONE, HOMOSALATE, OCTISALATE,Supergoop, LLC9f6cd243-ef5c-df8a-e053-2a95a90a4e362026-01-09WarningsExact identifier
application number: M020
Poolside Sun Silk Body Sunglow 05 Fragrance SPF 30 Sunscreen BodyHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONEI World LLC4416ad39-a4b5-4238-9792-c7f475d1e5612026-01-09WarningsExact identifier
application number: M020
Lip Screen Broad Spectrum SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCa3e5819a-5132-9760-e053-2a95a90a058b2026-01-09WarningsExact identifier
application number: M020
Poolside Orange Creme SPF 30 Scented SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONEI World LLCd96a1390-27be-452a-818b-0ba6127e9f962026-01-09WarningsExact identifier
application number: M020
Sugargirl Glowy SPF 30 Face Screen Daybreak Shimmer Sunscreen For the FaceHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONEI World LLC4554d9a8-33a1-4299-8a57-dab72980b2eb2026-01-09WarningsExact identifier
application number: M020
Sugargirl Glowy SPF 30 Face Screen Solar Shimmer Sunscreen For the FaceHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONEI World LLCb5be8ea7-3408-4495-9a50-3328f76987382026-01-09WarningsExact identifier
application number: M020
Sugargirl Glowy SPF 30 Face Screen Sunlight Shimmer Sunscreen For the FaceHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONEI World LLCc99464d1-a5bb-4140-a95e-25d6b383616c2026-01-09WarningsExact identifier
application number: M020
Sugargirl Set Screen SPF 30 Setting Powder Sunscreen LightZINC OXIDE, TITANIUM DIOXIDEI World LLC1fabd546-55e5-4ab2-8a1b-7b161bfbb8662026-01-09WarningsExact identifier
application number: M020
Sugargirl Set Screen SPF 30 Setting Sunscreen MediumZINC OXIDE, TITANIUM DIOXIDEI World LLC876a6f88-8dac-4303-8acb-525999c935282026-01-09WarningsExact identifier
application number: M020
Sugargirl Glowy Face Screen Sunbeam Shimmer Sunscreen For the Face SPF 30HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONEI World LLCf6316c4f-076a-4ba5-a526-0e20e5156ced2026-01-09WarningsExact identifier
application number: M020
Sugargirl Set Screen SPF 30 Setting Sunscreen TranslucentZINC OXIDE, TITANIUM DIOXIDEI World LLC0a3bae73-141b-4a47-be35-c5708dfb11802026-01-09WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Sand L2W1TITANIUM DIOXIDEAmway Corp4345cdf6-e220-4e7c-8abd-da59d2b7db842026-01-09WarningsExact identifier
application number: M020
Mineral Sheer Screen Broad Spectrum Sunscreen SPF 30ZINC OXIDESupergoop LLCb47ed3bf-92a8-9bc9-e053-2a95a90a8eee2026-01-09WarningsExact identifier
application number: M020
Daily Dose Hydra-Ceramide Boost Broad Spectrum Sunscreen SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCca5520a1-4c43-cb32-e053-2a95a90a97f52026-01-09WarningsExact identifier
application number: M020
100% Mineral Broad Spectrum Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDESupergoop LLCd6fcc065-cbcd-0b81-e053-2a95a90ab1f92026-01-09WarningsExact identifier
application number: M020
Glow Screen Body Broad Spectrum Sunscreen SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCb9590938-417d-617a-e053-2995a90a74962026-01-09WarningsExact identifier
application number: M020
100% Mineral Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDESupergoop LLCd7758651-c152-5868-e053-2a95a90ab6732026-01-09WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 30ZINC OXIDESupergoop, LLC4cf243b4-d794-401a-b209-18c7e550ef4f2026-01-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67225-5231-16722552310140 g in 1 TUBE40 gHistorical
67225-5231-2672255231021 TUBE in 1 BOX (67225-5231-2) / 40 g in 1 TUBE (67225-5231-1) 1 tube2024-02-22NoNoCurrent