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
Ingredient	Strength
AVOBENZONE	30 mg/g
HOMOSALATE	150 mg/g
MERADIMATE	50 mg/g
OCTISALATE	50 mg/g
OCTOCRYLENE	100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
J9QGD60OUZ	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
ef95f2b7-e438-4990-880d-81621edb2002	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
84440-003-10	Biocorneum	1 in 1 CARTON	GEL	1	1
84440-003-10	Biocorneum	10 g in 1 TUBE	GEL	10	1
84440-003-20	Biocorneum	20 g in 1 TUBE	GEL	20	1
84440-003-20	Biocorneum	1 in 1 CARTON	GEL	1	1
84440-003-50	Biocorneum	1 in 1 CARTON	GEL	1	1
84440-003-50	Biocorneum	50 g in 1 TUBE	GEL	50	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84440-003	BIOCORNEUM (AVOBENZONE, HOMOSALATE, MERADIMATE, OCTISALATE, AND OCTOCRYLENE) GEL [BIODERMIS LLC]	1	Current NDC, 6 package rows	20240901_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 251 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0d338ec2-dca0-e032-e063-6394a90a69aa	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0752d79d-5d82-0367-e063-6394a90a4f1c	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0d33888d-20b3-f912-e063-6394a90a25dc	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0d3379ba-465c-a889-e063-6394a90aaf23	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b25290-33a0-bafd-e063-6394a90a7a94	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0751b356-607f-f3cb-e063-6294a90a4092	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b14a17-cace-1b3e-e063-6394a90afe5d	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	07530636-cd21-3022-e063-6394a90a89d6	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0752753e-cac9-9166-e063-6394a90a4d8d	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06ad3c09-9f1b-b25c-e063-6294a90aebe1	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06c57ff5-7013-d35f-e063-6394a90a6ee2	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b1f8bc-8b29-451a-e063-6294a90a34bd	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b26dd0-44de-91a7-e063-6394a90a603a	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b26dd0-44ef-91a7-e063-6394a90a603a	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b25290-33a3-bafd-e063-6394a90a7a94	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b1f8bc-8b2b-451a-e063-6294a90a34bd	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b26dd0-44cb-91a7-e063-6394a90a603a	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b2b996-e02c-e40a-e063-6394a90aa0d9	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06c5efde-42e1-e4fc-e063-6394a90a491d	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06c5efde-42d0-e4fc-e063-6394a90a491d	2024-12-25	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
J9QGD60OUZ	MERADIMATE	134-09-8	MERADIMATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84440-003-10	84440000310	1 TUBE in 1 CARTON (84440-003-10) / 10 g in 1 TUBE	1 tube	2024-09-01	No	No	Current
84440-003-20	84440000320	1 TUBE in 1 CARTON (84440-003-20) / 20 g in 1 TUBE	1 tube	2024-09-01	No	No	Current
84440-003-50	84440000350	1 TUBE in 1 CARTON (84440-003-50) / 50 g in 1 TUBE	1 tube	2024-09-01	No	No	Current