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 143 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Maloney Plastic Surgery Skin Care, PLLC	316b46ac-6dde-72d1-e063-6294a90a03da	2025-12-09		Exact identifier application number: M020
Replenish	ZINC OXIDE	Maloney Plastic Surgery Skin Care, PLLC	316c43fb-0c15-87d4-e063-6294a90a0a63	2025-12-09		Exact identifier application number: M020
BIOJUVE Microbiome-Safe Sheer Finish SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	ece7565b-f3e5-3386-e053-2a95a90a5802	2025-12-09	Warnings	Exact identifier application number: M020
Hydraboost Lip Treatment	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Bluemercury	2cf30083-8723-23f6-e063-6394a90a55de	2025-12-09	Warnings	Exact identifier application number: M020
Florida Babe Sport Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Tichy Anesthesia PA	31e4756d-8604-6e75-e063-6294a90aebe1	2025-12-09		Exact identifier application number: M020
Florida Babe Sport Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Tichy Anesthesia PA	31e4d9ae-f532-f9f5-e063-6294a90a8d39	2025-12-09		Exact identifier application number: M020
Arbonne FunSun Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Arbonne International, LLC	91bcd120-28e5-4f44-9522-550c1dbcd82c	2025-12-09	Warnings	Exact identifier application number: M020
Florida Babe Active Tinted 20percent Zinc Oxide Mineral Sunscreen	ZINC OXIDE	Tichy Anesthesia PA	31e509f2-dcb6-5ae0-e063-6394a90a70c1	2025-12-09		Exact identifier application number: M020
Florida Babe Active Non-Tinted 20percent Zinc Oxide Mineral Sunscreen	ZINC OXIDE	Tichy Anesthesia PA	31e57817-b8c4-8178-e063-6294a90a0149	2025-12-09		Exact identifier application number: M020
Florida Babe Everyday Tinted Replenishing Daily Protection	ZINC OXIDE	Tichy Anesthesia PA	3231f1fe-51b3-b2e7-e063-6394a90a2758	2025-12-09		Exact identifier application number: M020
Florida Babe Everyday Tinted Replenishing Daily Protection	ZINC OXIDE	Tichy Anesthesia PA	31e63876-3e39-adc6-e063-6394a90ab146	2025-12-09		Exact identifier application number: M020
Florida Babe SPORT Mineral Sunscreen Stick Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Tichy Anesthesia PA	31f5bbe4-5f6e-3bef-e063-6294a90a2646	2025-12-09		Exact identifier application number: M020
Florida Babe SPORT Mineral Sunscreen Stick Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Tichy Anesthesia PA	31f54a79-70b7-def5-e063-6294a90a709b	2025-12-09		Exact identifier application number: M020
Florida Babe Sport Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Tichy Anesthesia PA	3231b71c-4d27-e5e2-e063-6294a90a031b	2025-12-09		Exact identifier application number: M020
Arbonne Soft Focus Veil Broad Spectrum SPF 30 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Arbonne International, LLC	3c9b605b-5a16-4f89-a956-8c4c62de72d3	2025-12-09	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	THE AESTHETICS ACADEMY, LLC	364b9560-f7a1-ed8f-e063-6294a90a2c41	2025-12-09		Exact identifier application number: M020
Sunshield Moisturizing Sunscreen and Antioxidant	ZINC OXIDE	Oculofacial Surgery andCosmetic Laser Institute, LLC.	32c247fc-d4da-e03d-e063-6394a90a72b0	2025-12-09		Exact identifier application number: M020
SCALP SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	FOLICULE LLC	387b10e1-5443-7b7a-e063-6394a90a2c7a	2025-12-09		Exact identifier application number: M020
Sunshield Moisturizing Sunscreen and Antioxidant	ZINC OXIDE	Oculofacial Surgery andCosmetic Laser Institute, LLC.	32c3936e-4089-edd0-e063-6294a90ad3f8	2025-12-09		Exact identifier application number: M020
Tinted Replenishing Daily Protection	ZINC OXIDE	THE AESTHETICS ACADEMY, LLC	364cf1f7-1f87-51f7-e063-6294a90a789c	2025-12-09		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