MEDICUBE PDRN SILKY SUNSCREEN Homosalate, Octocrylene, Octisalate, Avobenzone 6.5 g/100g; 6.5 g/100g; 4.5 g/100g; 2.8 g/100g Stick, 23 g
by APR US INC · 1 CONTAINER in 1 BOX (82440-201-04) / 23 g in 1 CONTAINER
NDC 82440-0201-04
🏷️ FDA NDC (as labeled)
82440-201-04
billing pads the product segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
82440-201-04
Product NDC
82440-201
11-digit billing NDC
82440020104
UNII
V06SV4M95S, 5A68WGF6WM, 4X49Y0596W, G63QQF2NOX
Application #
M020
SPL Set ID
57154bec-6714-0314-e063-6294a90a4bd0
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2026-08-01
Route
TOPICAL
Dosage form
STICK
Substance
HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE
Why two NDCs?
The FDA registers this code as 82440-201-04 — 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 → 82440-0201-04. 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
LabelerAPR US INC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code82440
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio4 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?
Medicube PDRN Silky Sunscreen is an over-the-counter sunscreen stick applied to the skin. It contains four UV-filtering ingredients (homosalate, octocrylene, octisalate, and avobenzone) that work together to absorb and scatter ultraviolet light from the sun. This product is marketed under the FDA's OTC sunscreen monograph, which sets the rules for how such products may be formulated and labeled. Sunscreens are typically used to help protect exposed skin from the sun's damaging rays.
Patient education
Supplement & herbal interactions
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.
💬 Questions about Homosalate, Octocrylene, Octisalate, Avobenzone?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 2EH13UN8D3
A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
-
UNII YCD50O0Z6L
A synthetic oily liquid used as a solvent and conditioning agent in topical formulations. It helps dissolve other ingredients and improves how the product spreads and feels on skin.
-
UNII QBS8A3XZGQ
A synthetic oil made from diisostearyl alcohol and malic acid. It serves as an emollient and solvent in formulations, helping to dissolve and deliver active ingredients while improving texture and spreadability.
-
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.
4 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesMethyl Methacrylate Crosspolymer, Diethylhexyl Carbonate, Synthetic Wax, Diisostearyl Malate, Butyloctyl Salicylate, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyphenylsilsesquioxane, Ethylhexyl Isononanoate, Isopropyl Palmitate, Dimethiconol, Trisiloxane, Bis-Behenyl/Isostearyl/Phytosteryl Dimer Dilinoleyl Dimer Dilinoleate, Diphenylsiloxy Phenyl Trimethicone, Synthetic Fluorphlogopite, Polymethylsilsesquioxane, Ethylene/Propylene Copolymer, Silica Dimethyl Silylate, Polyethylene, Dimethicone Crosspolymer, Candelilla Wax Esters, Olea Europaea (Olive) Fruit Oil, Copernicia Cerifera (Carnauba) Wax, Amyris Balsamifera Bark Oil, Angelica Archangelica Root Oil, Citrus Aurantium Amara (Bitter Orange) Leaf/Twig Oil, Ferula Galbaniflua (Galbanum) Resin Oil, Jasminum Officinale (Jasmine) Oil, Water, Ceramide NP, Niacinamide, Sodium Hyaluronate, Tocopheryl Acetate, Butylene Glycol, 1,2-Hexanediol, Aloe Barbadensis Leaf Juice, Ethylhexylglycerin, Hydrolyzed Collagen, Sodium DNA
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 system | Per each | Per 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.
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Medicube Pdrn Silky Sunscreen 6.5 g/100g; 6.5 g/100g; 4.5 g/100g; 2.8 g/100gthis 82440-0201-04 | APR | 23 g | — | — | 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
🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 Homosalate, Octocrylene, Octisalate, Avobenzone — the ingredient across all brands.
Top reported reactions
Reporter sex
Female · 100%
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 82440-0201-04 You're viewing this | 1 CONTAINER in 1 BOX (82440-201-04) / 23 g in 1 CONTAINER | 2026-08-01 | Active |
🧭 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 | — Not published for this NDC No photo available yet for this listing. |
| 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 82440-201-04, 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: 82440-0201-04, written without dashes as 82440020104. 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 82440-0201-04, the first segment (82440) is the labeler code FDA assigned to APR US INC; the middle segment (0201) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 APR US INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
APR US INC 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 ▾
Uses • Helps prevent sunburn. • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
⏱️ Dosage and Administration ▾
Directions Apply liberally and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor. Reapply: • after 80 minutes of swimming or sweating. • immediately after towel drying. • at least every 2 hours Sun Protection Measures : Spending time in the sun increases your risk of skin cancer and early skin aging.
To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses.
⚠️ Warnings ▾
For external use only. 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. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away
🧪 Inactive Ingredients ▾
Methyl Methacrylate Crosspolymer, Diethylhexyl Carbonate, Synthetic Wax, Diisostearyl Malate, Butyloctyl Salicylate, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyphenylsilsesquioxane, Ethylhexyl Isononanoate, Isopropyl Palmitate, Dimethiconol, Trisiloxane, Bis-Behenyl/Isostearyl/Phytosteryl Dimer Dilinoleyl Dimer Dilinoleate, Diphenylsiloxy Phenyl Trimethicone, Synthetic Fluorphlogopite, Polymethylsilsesquioxane, Ethylene/Propylene Copolymer, Silica Dimethyl Silylate, Polyethylene, Dimethicone Crosspolymer, Candelilla Wax Esters, Olea Europaea (Olive) Fruit Oil, Copernicia Cerifera (Carnauba) Wax, Amyris Balsamifera Bark Oil, Angelica Archangelica Root Oil, Citrus Aurantium Amara (Bitter Orange) Leaf/Twig Oil, Ferula Galbaniflua (Galbanum) Resin Oil, Jasminum Officinale (Jasmine) Oil, Water, Ceramide NP, Niacinamide, Sodium Hyaluronate, Tocopheryl Acetate, Butylene Glycol, 1,2-Hexanediol, Aloe Barbadensis Leaf Juice, Ethylhexylglycerin, Hydrolyzed Collagen, Sodium DNA
🎯 Purpose ▾
Sunscreen
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.