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Biocorneum Avobenzone, Homosalate, Meradimate, Octisalate, and Octocrylene 30 mg/g; 150 mg/g; 50 mg/g; 50 mg/g; 100 mg/g Gel — NDC 84440-0003-20 package photo

Biocorneum Avobenzone, Homosalate, Meradimate, Octisalate, and Octocrylene 30 mg/g; 150 mg/g; 50 mg/g; 50 mg/g; 100 mg/g Gel

by Biodermis LLC · 1 TUBE in 1 CARTON (84440-003-20) / 20 g in 1 TUBE
NDC 84440-0003-20
🏷️ FDA NDC (as labeled) 84440-003-20 billing pads the product segment with a zero
This package
Contains20 g in 1 tube Pack sizes3 compare ↓
Also comes in: 10 g 84440-0003-10 50 g 84440-0003-50
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 84440-003-20
Product NDC 84440-003
11-digit billing NDC 84440000320
UNII G63QQF2NOX, V06SV4M95S, J9QGD60OUZ, 4X49Y0596W, 5A68WGF6WM
Application # M020
SPL Set ID ef95f2b7-e438-4990-880d-81621edb2002
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-09-01
Route TOPICAL
Dosage form GEL
Substance AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 84440-003-20 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 84440-0003-20. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerBiodermis LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84440
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio2 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

Biocorneum is a topical gel sunscreen marketed as an over-the-counter monograph product. It contains five UV-filtering ingredients (avobenzone, homosalate, meradimate, octisalate, and octocrylene) that are typically used together to absorb and scatter ultraviolet radiation. These agents are commonly found in broad-spectrum sunscreen products intended to help protect skin from sun exposure when applied topically.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII UF7620L1W6
    A synthetic silicone polymer that acts as a thickener and absorbent in medicines. It helps create the right texture, improves how the product feels on skin or in the mouth, and can absorb excess moisture or oil in formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.

4 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesCyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Silicon Dioxide

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 g 50 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Biocorneum 30 mg/g; 150 mg/g; 50 mg/g; 50 mg/g; 100 mg/gthis 84440-0003-20 Biodermis 1 tube — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Biocorneum (this brand).

Top reported reactions

Atrial Fibrillation1

Age at onset

Elderly1

Reporter sex

1 reports
Male · 100%
Reports over time (by year) — tap or hover for the count & year
2025 2026 1 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
84440-0003-10 1 TUBE in 1 CARTON (84440-003-10) / 10 g in 1 TUBE 2024-09-01 Active
84440-0003-20 You're viewing this 1 TUBE in 1 CARTON (84440-003-20) / 20 g in 1 TUBE 2024-09-01 Active
84440-0003-50 1 TUBE in 1 CARTON (84440-003-50) / 50 g in 1 TUBE 2024-09-01 Active

Pack size FAQ

What quantity is in NDC 84440-0003-20?
NDC 84440-0003-20 is listed by the FDA — 1 tube in 1 carton / 20 g in 1 tube.
What NDC number is used to bill for this package of Biocorneum Avobenzone, Homosalate, Meradimate, Octisalate, and Octocrylene 30 mg/g; 150 mg/g; 50 mg/g; 50 mg/g; 100 mg/g Gel?
Bill NDC 84440-0003-20 — the 11-digit billing format is 84440000320. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 84440-003-20, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 84440-0003-20, written without dashes as 84440000320. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 84440-0003-20, the first segment (84440) is the labeler code FDA assigned to Biodermis LLC; the middle segment (0003) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (20) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Biodermis LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 tube (84440-0003-10), 1 tube (84440-0003-50). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Biodermis LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 37 words ▾

Uses BIOCORNEUM ® can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes (such as joints) and areas exposed to sun (such as the face and hands).

⏱️ Dosage and Administration 35 words ▾

Directions Ensure that the affected area is clean and dry. Apply a thin, even layer twice daily. Allow to dry. Wait 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor.

⚠️ Warnings 77 words ▾

Warnings Skin Cancer/Skin Aging Alert Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. For external use only. Keep out of reach of children. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.

📦 Storage and Handling 13 words ▾

Other Information Protect product in this container from excessive heat and direct sun.

🧪 Active Ingredient 21 words ▾

Active Ingredients Purpose Avobenzone 3% Sunscreen Homosalate 15% Sunscreen Meradimate 5% Sunscreen Octisalate 5% Sunscreen Octocrylene 10% Sunscreen Dosage Form: Gel

🧪 Inactive Ingredients 8 words ▾

Inactive Ingredients Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Silicon Dioxide

🎯 Purpose 21 words ▾

Active Ingredients Purpose Avobenzone 3% Sunscreen Homosalate 15% Sunscreen Meradimate 5% Sunscreen Octisalate 5% Sunscreen Octocrylene 10% Sunscreen Dosage Form: Gel

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84438-0942-01 · Bitchstix, 84440-0608-01 · Biodermis, →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.