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 249 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06c62206-d838-8d9a-e063-6394a90a4c69	2024-12-26	Warnings	Exact identifier application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Light	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	fbbff4eb-a63e-b083-e053-6294a90a404a	2024-12-26	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06c6035e-c179-b3e6-e063-6394a90a86cd	2024-12-26	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06c618ae-3d4d-8c87-e063-6394a90a5396	2024-12-26	Warnings	Exact identifier application number: M020
KOPARI Sun Shield Soft Glow Daily Face SPF30	OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE	COSMAX USA, CORPORATION	0d436d06-3f81-b4a6-e063-6294a90aa635	2024-12-26	Warnings	Exact identifier application number: M020
NEORA Invisibloc Sunscreen Gel Broad Spectrum SPF40	AVOBENZONE, HOMOSALATE, OCTISALATE	COSMAX USA, CORPORATION	0d584736-3f55-2542-e063-6294a90af3cf	2024-12-26	Warnings	Exact identifier application number: M020
NARS Radiance Primer Broad Spectrum SPF 35 Sunscreen	OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE	COSMAX USA, CORPORATION	0d59d9cb-c891-1097-e063-6394a90a806e	2024-12-26	Warnings	Exact identifier application number: M020
KOPARI Sun Shield Soft Glow Daily Face SPF30	OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE	COSMAX USA, CORPORATION	0d3673da-822b-09e2-e063-6394a90a348e	2024-12-26	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06c61c42-eddb-1ebd-e063-6294a90aee13	2024-12-26	Warnings	Exact identifier application number: M020
GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35	AVOBENZONE, HOMOSALATE, OCTISALATE	COSMAX USA, CORPORATION	0d438692-cd83-ea42-e063-6394a90a862d	2024-12-26	Warnings	Exact identifier application number: M020
KOPARI Antioxidant Face Shield Mineral SPF 30	ZINC OXIDE	COSMAX USA, CORPORATION	0d43e22c-5e3d-df90-e063-6294a90aac2b	2024-12-26	Warnings	Exact identifier application number: M020
NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30	TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, CORPORATION	0d489154-6168-977e-e063-6394a90aa609	2024-12-26	Warnings	Exact identifier application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Fair	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	fbbfa61a-cbb4-3104-e053-6394a90a832f	2024-12-26	Warnings	Exact identifier application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Tan to dark	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	e6c4b8eb-5aa3-49c2-af9e-eaf5fafb029c	2024-12-26	Warnings	Exact identifier application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Light to Medium	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	fbc05ceb-2e6b-3c37-e053-6394a90ac4f4	2024-12-26	Warnings	Exact identifier application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Medium	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	fbc0ff10-fb2f-e637-e053-6294a90a0c29	2024-12-26	Warnings	Exact identifier application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Deep	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	2984c64f-eaac-ecb6-e063-6394a90aeb12	2024-12-26	Warnings	Exact identifier application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Tan	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	2984a014-a56f-753b-e063-6294a90a13f5	2024-12-26	Warnings	Exact identifier application number: M020
Julep No Excuses Gel for Face SPF40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	298404c4-d4be-7395-e063-6294a90a86bf	2024-12-26	Warnings	Exact identifier application number: M020
Cover FX Invisible Primer SPF30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	2983dd7c-7ca7-e952-e063-6394a90a3098	2024-12-26	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