FDA.reportPublic FDA data

Biocorneum

Product NDC
84440-003
11-digit product format
844400003
Labeler code
84440
Product ID
84440-003_2996022f-311c-4161-b6cc-1c746e9151d9
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Meradimate, Octisalate, and Octocrylene
Dosage form
GEL
Route
TOPICAL
Labeler
Biodermis LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-01
Substance
AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 150; 50; 50; 100 mg/g; mg/g; mg/g; mg/g; mg/g
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
Biocorneum
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
HOMOSALATE150 mg/g
MERADIMATE50 mg/g
OCTISALATE50 mg/g
OCTOCRYLENE100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
J9QGD60OUZInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ef95f2b7-e438-4990-880d-81621edb2002Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84440-003-10Biocorneum1 in 1 CARTONGEL11
84440-003-10Biocorneum10 g in 1 TUBEGEL101
84440-003-20Biocorneum20 g in 1 TUBEGEL201
84440-003-20Biocorneum1 in 1 CARTONGEL11
84440-003-50Biocorneum1 in 1 CARTONGEL11
84440-003-50Biocorneum50 g in 1 TUBEGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84440-003BIOCORNEUM (AVOBENZONE, HOMOSALATE, MERADIMATE, OCTISALATE, AND OCTOCRYLENE) GEL [BIODERMIS LLC]1Current NDC, 6 package rows20240901_ef95f2b7-e438-4990-880d-81621edb2002.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 189 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Everlast Foundation SPF 20 38C DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L0358a87d-8002-4f3e-851a-3a582d356edf2025-09-03WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 39N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L34dfc4c5-44f7-4531-97ba-8846ebe147242025-09-03WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 40C DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lcf4b6f45-d4ae-4665-87b4-c5af4910befa2025-09-03WarningsExact identifier
application number: M020
DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATIONOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDOLCE & GABBANA BEAUTY SRLeb63e9c6-bdb0-4bdf-8822-e4561a56adc92025-09-03WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 1N LightZINC OXIDEDolce & Gabbana Beauty S.R.L9507681c-236c-41c1-9dc9-ed4c0c0917412025-09-03WarningsExact identifier
application number: M020
Pure6 ManiShield Hand ScreenZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3abcb6ba-1de8-55e7-e063-6294a90aecf12025-09-02WarningsExact identifier
application number: M020
Round Lab Dodo s Pick Bestseller SetAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.3dd3db99-2e9f-16fc-e063-6294a90adda12025-09-02WarningsExact identifier
application number: M020
Sun Bum Premium Sunscreen Face Stick Broad Spectrum SPF 30 Sunscreen - PeggedAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3d86da52-6354-f53e-e063-6394a90aac552025-09-02WarningsExact identifier
application number: M020
Sun Bum Road Tripper Mineral - Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDESun Bum, LLC3dd7b0af-dc37-1701-e063-6294a90a65c32025-09-02WarningsExact identifier
application number: M020
toty Ilumina CC Creamy Compact 6NTITANIUM DIOXIDEChipican LLC3da732e7-19b0-3195-e063-6394a90a9a0c2025-09-01WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3dba1360-f70f-e450-e063-6394a90a8c9f2025-09-01WarningsExact identifier
application number: M020
TOCOBO Cotton Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.2f7e7ef4-c3ac-4c26-e063-6394a90a9e422025-09-01WarningsExact identifier
application number: M020
TOCOBO Bio Watery Sun ScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.3a7db6f4-66fd-4473-e063-6394a90a886e2025-09-01WarningsExact identifier
application number: M020
TOCOBO Bio Watery Sun ScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.2f7eb413-ff49-711d-e063-6394a90ad6dc2025-09-01WarningsExact identifier
application number: M020
Ocean Potion Suncare Mineral 30 Essential Scent of Sunshine Zinc Oxide SunscreenZINC OXIDEGNL BRANDS INTERNATIONAL, LLC3db1cf3e-0640-6821-e063-6294a90a70362025-08-31WarningsExact identifier
application number: M020
Purpose Dual Treatment SPF 10OCTINOXATE 7.5%, OCTISALATE 5%, OXYBENZONE 3%Elysium Consumer Healthcare LLC3d7fe711-a671-df30-e063-6394a90afbbf2025-08-29WarningsExact identifier
application number: M020
Good Weather Skin The One Daily Sun Warm Glow SPF 30ZINC OXIDEGood Weather Inc.3d83aaa5-0e4e-928a-e063-6294a90a24da2025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 33N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Le249507c-d536-4c1d-a99d-857ca1e833d82025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 32W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lba99edea-bf68-4118-8bb7-ea40322db46a2025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 34W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3a239897-9850-417f-8c00-e810a52540c12025-08-29WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84440-003-10844400003101 TUBE in 1 CARTON (84440-003-10) / 10 g in 1 TUBE1 tube2024-09-01NoNoCurrent
84440-003-20844400003201 TUBE in 1 CARTON (84440-003-20) / 20 g in 1 TUBE1 tube2024-09-01NoNoCurrent
84440-003-50844400003501 TUBE in 1 CARTON (84440-003-50) / 50 g in 1 TUBE1 tube2024-09-01NoNoCurrent