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PRVWORA Ultra Defense Sunscreen Avobenzone, Octinoxate, Octisalate, Octocrylene 72.5 mg/mL; 45 mg/mL; 95 mg/mL; 28.5 mg/mL Cream — NDC 87482-0001-02 package photo

PRVWORA Ultra Defense Sunscreen Avobenzone, Octinoxate, Octisalate, Octocrylene 72.5 mg/mL; 45 mg/mL; 95 mg/mL; 28.5 mg/mL Cream

by Cellarkbio Inc. · 1 TUBE in 1 CARTON (87482-001-02) / 50 mL in 1 TUBE (87482-001-01)
NDC 87482-0001-02
🏷️ FDA NDC (as labeled) 87482-001-02 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 →

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) 87482-001-02
Product NDC 87482-001
11-digit billing NDC 87482000102
UNII 4Y5P7MUD51, 4X49Y0596W, 5A68WGF6WM, G63QQF2NOX
Application # M020
SPL Set ID 50cf1d88-3e7e-47b7-816a-3d579bde0a6a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-04
Route TOPICAL
Dosage form CREAM
Substance OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE
Why two NDCs? The FDA registers this code as 87482-001-02 — 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 → 87482-0001-02. 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

LabelerCellarkbio Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code87482
First marketedApr 2026
Product typeHuman Otc Drug
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?

PRVWORA Ultra Defense Sunscreen is a topical cream that contains four UV-filtering ingredients: avobenzone, octinoxate, octisalate, and octocrylene. These chemicals are commonly used together in sunscreen products to help absorb ultraviolet light and reduce its transmission to the skin. This is an over-the-counter monograph product, meaning it is marketed under FDA's established rules for sunscreen ingredients rather than as an individually reviewed drug application. The product is intended to be applied to exposed skin as part of sun protection routines.

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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII H5ZUQ6V4AK
    Octadecene is a synthetic hydrocarbon derived from petroleum. It works as a lubricant and glidant to help powder flow smoothly during tablet manufacturing and packaging.
  • UNII 2IK4UQ3ZGA
    A synthetic chemical compound used in topical formulations as an antioxidant and stabilizer. It helps prevent degradation of active ingredients and maintains product consistency during storage.
  • UNII Q7UI015FF9
    A synthetic polymer material used as a thickener and stabilizer in liquid formulations. It helps create the right texture and prevents separation of ingredients in medicines and topical products.
  • UNII LZ291VH90H
    A synthetic polymer used as a thickener and stabilizer in liquid and gel formulations. It increases viscosity to achieve the desired texture and helps keep ingredients uniformly mixed throughout the product.
  • UNII D64PM5UT4U
    A synthetic plastic-like material made from behenyl acrylate monomers. It's used as a film-former and binder to help hold tablet ingredients together and create protective coatings on medications.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • 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 K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • 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 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII S3KFG6Q5X8
    An organic chemical compound used as a UV filter in topical formulations. It helps protect the medicine or product from degradation caused by sunlight exposure during storage and use.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII 7IGF0S7R8I
    Phytic acid is a naturally occurring compound found in plants that acts as a chelating agent and preservative in medicines. It helps stabilize formulations and prevent oxidation of active ingredients.
  • UNII WQ29KQ9POT
    Gluconolactone is a mild organic acid derived from glucose. It functions as a buffer and pH regulator in medicines, helping maintain stable acidity levels and improve product stability.
  • UNII 918X1OUF1E
    Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
  • UNII NH496X0UJX
    Mandelic acid is an organic acid derived from almonds. It functions as a buffer and pH adjuster in medications, helping maintain the product's stability and proper acidity level.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII W19EIO0DBE
    A plant-derived emulsifier made from glycerin and fatty acids. It helps mix oil and water-based ingredients together and stabilizes the product's texture in creams, lotions, and other cosmetic or topical formulations.
  • UNII 4T2L7QI313
    A waxy, plant-derived thickener made from glycerol and behenic acid. It's used as an emulsifier and stabilizer to help blend oil and water-based ingredients together and maintain texture in creams and lotions.
  • UNII ETY9Q81E2T
    A synthetic emulsifier made from glycerin and stearic acid. It helps blend oil and water-based ingredients together so the medicine mixes evenly and stays stable.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • 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.
  • UNII 1DXE3F3OZX
    A synthetic polymer that forms a gel-like network. It absorbs and holds water, thickens the medicine, and helps keep ingredients evenly mixed throughout the formulation.
  • UNII 65A9F4P024
    A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
  • UNII R327X197HY
    Stearyl dimethicone is a silicone compound that acts as a lubricant and glidant in tablet and capsule formulations. It reduces friction between particles and on manufacturing equipment, helping the medicine flow smoothly during production and preventing clumping.
  • UNII 6T84R30KC1
    Tranexamic acid is a synthetic compound that helps reduce bleeding by slowing the breakdown of blood clots. In medicines, it acts as an active pharmaceutical ingredient rather than an inactive filler, and is included to provide therapeutic effects related to bleeding control.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesWater, Silica, Propanediol, Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Butylene Glycol, 1,2-Hexanediol, Sodium Stearoyl Glutamate, Polyglyceryl-6 Stearate, Dimethicone, Stearyl Dimethicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydrolyzed Sclerotium Gum, Polyglyceryl-3 Methylglucose Distearate, Octadecene, Ammonium Acryloyldimethyltaurate/Beheneth-25 Methacrylate Crosspolymer, Microcrystalline Cellulose, Isohexadecane, Poly C10-30 Alkyl Acrylate, Ethylhexylglycerin, Polyacrylate Crosspolymer-6, Fragrance, Disodium EDTA, Xanthan Gum, Polysorbate 80, Polyglyceryl-6 Behenate, Cellulose Gum, Niacinamide, Tranexamic Acid, 4-Butylresorcinol, Gluconolactone, Mandelic Acid, D-Pentapeptide-1, Phytic Acid

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.
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
PRVWORA Ultra Defense Sunscreen 72.5 mg/mL; 45 mg/mL; 95 mg/mL; 28.5 mg/mLthis 87482-0001-02 Cellarkbio 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

🏛️
2026
On the market since
Apr 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
87482-0001-02 You're viewing this 1 TUBE in 1 CARTON (87482-001-02) / 50 mL in 1 TUBE (87482-001-01) 2026-04-04 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 ✓ 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 87482-001-02, 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: 87482-0001-02, written without dashes as 87482000102. 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 87482-0001-02, the first segment (87482) is the labeler code FDA assigned to Cellarkbio Inc.; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Cellarkbio Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cellarkbio 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 28 words ▾

Helps prevent sunburn If used as directed with other sun protection measures (see Directions) decrease the risk of skin cancer and early skin aging caused by the sun

⏱️ Dosage and Administration 87 words ▾

For sunscreen use: Apply liberally 15 minutes before sun exposure Reapply at least every two hours Use a water-resistant sunscreen if swimming or sweating 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: 1) Limit time in the sun, especially from 10 a.m. to 2 p.m.

2) Wear long-sleeved shirts, pants, hats, and sunglasses

⚠️ Warnings 34 words ▾

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.

🧪 Active Ingredient 8 words ▾

Avobenzone 2.85% Octinoxate 7.25% Octisalate 4.50% Octocrylene 9.50%

🧪 Inactive Ingredients 65 words ▾

Water, Silica, Propanediol, Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Butylene Glycol, 1,2-Hexanediol, Sodium Stearoyl Glutamate, Polyglyceryl-6 Stearate, Dimethicone, Stearyl Dimethicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydrolyzed Sclerotium Gum, Polyglyceryl-3 Methylglucose Distearate, Octadecene, Ammonium Acryloyldimethyltaurate/Beheneth-25 Methacrylate Crosspolymer, Microcrystalline Cellulose, Isohexadecane, Poly C10-30 Alkyl Acrylate, Ethylhexylglycerin, Polyacrylate Crosspolymer-6, Fragrance, Disodium EDTA, Xanthan Gum, Polysorbate 80, Polyglyceryl-6 Behenate, Cellulose Gum, Niacinamide, Tranexamic Acid, 4-Butylresorcinol, Gluconolactone, Mandelic Acid, D-Pentapeptide-1, Phytic Acid

🎯 Purpose 1 words ▾

Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 87478-0907-00 · Civant 87486-0100-01 · EADEM, →
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.