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Ultra Violette Supreme Screen Broad Spectrum SPF 50 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE 70 mg/mL; 30 mg/mL; 50 mg/mL; 80 mg/mL Cream, 50 mL — NDC 84803-0100-50 package photo

Ultra Violette Supreme Screen Broad Spectrum SPF 50 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE 70 mg/mL; 30 mg/mL; 50 mg/mL; 80 mg/mL Cream, 50 mL

by Grace and Fire USA Inc. · 50 mL in 1 TUBE (84803-100-50)
NDC 84803-0100-50
🏷️ FDA NDC (as labeled) 84803-100-50 billing pads the product segment with a zero
This package
Contains50 mL Pack sizes5 compare ↓
Also comes in: 5 ml 84803-0100-05 15 ml 84803-0100-15 20 ml 84803-0100-20 100 ml 84803-0100-10
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) 84803-100-50
Product NDC 84803-100
11-digit billing NDC 84803010050
UNII V06SV4M95S, G63QQF2NOX, 4X49Y0596W, 5A68WGF6WM
UPC 9355909005917
Application # M020
SPL Set ID 24389324-19db-7eb5-e063-6394a90ad7fb
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-12-01
Route TOPICAL
Dosage form CREAM
Substance HOMOSALATE; AVOBENZONE; OCTISALATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 84803-100-50 — 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 → 84803-0100-50. 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

LabelerGrace and Fire USA Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84803
First marketedDec 2024
Product typeHuman Otc Drug
Portfolio13 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?

Ultra Violette Supreme Screen is a broad-spectrum sunscreen cream applied to the skin to help protect against ultraviolet (UV) rays. It contains four active ingredients: avobenzone, homosalate, octisalate, and octocrylene, which are all UV-filtering compounds that work together to absorb and scatter UVA and UVB radiation. This is an over-the-counter monograph drug, meaning it is marketed under FDA guidelines for sunscreen products rather than as an individually approved application.

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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 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 UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • UNII Q95M2P1KJL
    A silicone-based ingredient that acts as a lubricant and glidant. It helps the tablet or capsule move smoothly through manufacturing equipment and improves powder flow during production.
  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII 8HO6PVN24W
    Carnosine is a naturally occurring compound made from two amino acids. In medicines, it may serve as a buffer to help maintain the product's pH stability.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII P7E6YFV72X
    Diisopropyl adipate is a clear, oily liquid derived from adipic acid. It acts as a plasticizer and solvent in medicines, helping soften coatings and improve how the drug dissolves or spreads in the body.
  • 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 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • UNII 86FQE96TZ4
    A synthetic polymer, this ingredient acts as a thickener and suspending agent in liquid formulations. It helps maintain uniform consistency and keeps particles evenly distributed throughout the medicine.
  • UNII A8289P68Y2
    Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
  • UNII 0ZQ1D2FDLI
    A fruit extract from the kakadu plum tree, native to Australia. It's used in formulations as a source of vitamin C and as an antioxidant to help preserve the medicine's stability.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII 446U8J075B
    Nylon-12 is a synthetic plastic polymer used as a coating or film-forming agent in medicines. It helps create a protective barrier around tablets or capsules to control how and when the medicine is released in the body.
  • UNII ECU18C66Q7
    PEG-40 stearate is a synthetic compound made by combining polyethylene glycol with stearic acid. It acts as an emulsifier and solubilizer to help mix oil and water-based ingredients together and improve how the medicine dissolves and is absorbed.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • UNII YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII R60QEP13IC
    Rice bran is a natural powder made from the outer layer of rice grains. It's used in medicines as a filler and flow agent to add bulk and help the product mix and flow smoothly during manufacturing.
  • UNII W8K377W98I
    A mixture of sugars made by rearranging glucose molecules. It acts as a sweetener and filler to improve taste and add bulk to the medicine while helping it hold together.
  • 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 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 01S2G2C1E4
    Sorbitan isostearate is an emulsifier derived from sorbitol and isostearic acid. It helps mix oil and water-based ingredients together and keeps them blended throughout the medicine's shelf life.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • 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.

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

The official label also statesWater, Alcohol Denat., Butylene Glycol, Diisopropyl Adipate, Glycerin, Cetearyl Alcohol, Caprylyl Methicone, lsododecane, Copernicia Cerifera (Camauba) Wax, Oryza Saliva (Rice) Bran Wax, Polysorbate 60, Dimethicone, Ceteareth-20, Nylon- 6/12, Saccharide lsomerate, Squalane, Camosine, Tocopheryl Acetate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Silica, PEG-40 Stearate, Citric Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Caprylate, Fragrance, Disodium EDTA, Pentylene Glycol, Caprylhydroxamic Acid, Triethanolamine, Lactic Acid, Sorbitan lsostearate, Sodium Citrate, Iron Oxides (Cl 77491), Iron Oxides (Cl 77492), Iron Oxides (Cl 77499).

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: 5 ml 15 ml 20 ml 100 ml
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
Ultra Violette Supreme Screen Broad Spectrum SPF 50 70 mg/mL; 30 mg/mL; 50 mg/mL; 80 mg/mLthis 84803-0100-50 Grace 50 ml — — 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
Dec 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
84803-0100-05 5 mL in 1 TUBE (84803-100-05) 2024-12-01 Active
84803-0100-15 15 mL in 1 TUBE (84803-100-15) 2024-12-01 Active
84803-0100-20 20 mL in 1 BOTTLE, PLASTIC (84803-100-20) 2024-12-01 Active
84803-0100-50 You're viewing this 50 mL in 1 TUBE (84803-100-50) 2024-12-01 Active
84803-0100-10 100 mL in 1 BOTTLE (84803-100-10) 2026-07-08 Active

You're viewing one of 5 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 84803-0100-50?
NDC 84803-0100-50 contains 50 mL — 50 ml in 1 tube.
What is the difference between NDC 84803-0100-50 and NDC 84803-0100-05?
Both are Ultra Violette Supreme Screen Broad Spectrum SPF 50 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE 70 mg/mL; 30 mg/mL; 50 mg/mL; 80 mg/mL Cream — the drug itself is identical. NDC 84803-0100-50 is the 50 mL package, while NDC 84803-0100-05 is the 5 ml package.
What NDC number is used to bill for this package of Ultra Violette Supreme Screen Broad Spectrum SPF 50 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE 70 mg/mL; 30 mg/mL; 50 mg/mL; 80 mg/mL Cream?
Bill NDC 84803-0100-50 — the 11-digit billing format is 84803010050. 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 84803-100-50, 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: 84803-0100-50, written without dashes as 84803010050. 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 84803-0100-50, the first segment (84803) is the labeler code FDA assigned to Grace and Fire USA Inc.; the middle segment (0100) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) 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 Grace and Fire USA Inc.. 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 4 other package presentations of this same product, including 5 ml (84803-0100-05), 15 ml (84803-0100-15), 20 ml (84803-0100-20). 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?
Grace and Fire USA 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 29 words ▾

USE 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 94 words ▾

Directions Apply liberally 15 minutes before sun exposure Reapply at least every 2 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: limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months of age: Ask a doctor

⚠️ Warnings 53 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 Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 11 words ▾

Other Information protect this product from excessive heat and direct sun

🧪 Active Ingredient 10 words ▾

ACTIVE INGREDIENTS AVOBENZONE 3.0% HOMOSALATE 7.0% OCTISALATE 5.0% OCTOCRYLENE 8.0%

🧪 Inactive Ingredients 80 words ▾

Inactive Ingredients Water, Alcohol Denat., Butylene Glycol, Diisopropyl Adipate, Glycerin, Cetearyl Alcohol, Caprylyl Methicone, lsododecane, Copernicia Cerifera (Camauba) Wax, Oryza Saliva (Rice) Bran Wax, Polysorbate 60, Dimethicone, Ceteareth-20, Nylon- 6/12, Saccharide lsomerate, Squalane, Camosine, Tocopheryl Acetate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Silica, PEG-40 Stearate, Citric Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Caprylate, Fragrance, Disodium EDTA, Pentylene Glycol, Caprylhydroxamic Acid, Triethanolamine, Lactic Acid, Sorbitan lsostearate, Sodium Citrate, Iron Oxides (Cl 77491), Iron Oxides (Cl 77492), Iron Oxides (Cl 77499).

🎯 Purpose 2 words ▾

PURPOSE SUNSCREEN

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84797-0000-49 · PharmaNutra 84803-0101-30 · Grace →
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.