Home › NDC Lookup › Ingredients › Homosalate, Octinoxate, Zinc Oxide › 85455-0100-01
burnd Homosalate, Octinoxate, Zinc Oxide 8 g/100mL; 7.5 g/100mL; 8.1 g/100mL Lotion, 100 mL — NDC 85455-0100-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

burnd Homosalate, Octinoxate, Zinc Oxide 8 g/100mL; 7.5 g/100mL; 8.1 g/100mL Lotion, 100 mL — NDC 85455-100-01 (Billing 85455-0100-01)

by BURND LLC · 100 mL in 1 TUBE

This is a package of 100 mL of burnd Homosalate, Octinoxate, Zinc Oxide 8 g/100mL; 7.5 g/100mL; 8.1 g/100mL Lotion from BURND LLC, marketed since Apr 2025 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 85455-0100-01
🏷️ FDA NDC (as labeled) 85455-100-01 billing pads the product segment with a zero
This package
Contains100 mL Pack sizes3 compare ↓
Main listing for product 85455-100 · Also comes in: 5.9 ml 85455-100-62 7.5 ml 85455-100-61
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 85455-100-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
85455 labeler · 100 product · 01 package
Package marketed since
Apr 9, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0850056302111
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85455-100-01
Product NDC 85455-100
11-digit billing NDC 85455010001
UNII V06SV4M95S, 4Y5P7MUD51, SOI2LOH54Z
UPC 0850056302111
Application # M020
SPL Set ID 31cf923e-fdde-790b-e063-6294a90a60ee
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-04-09
Route TOPICAL
Dosage form LOTION
Substance HOMOSALATE; OCTINOXATE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 85455-100-01 — 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 → 85455-0100-01. 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.

Clinical

🧪 What is this product?

This is a topical lotion containing three active ingredients commonly used as ultraviolet (UV) filters in sunscreen products. Homosalate and octinoxate are organic UV absorbers that function to block UVB and UVA rays from reaching the skin. Zinc oxide is a mineral UV reflectant that works by scattering and reflecting UV radiation away from the skin. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established safety and effectiveness guidelines for sunscreen ingredients rather than undergoing individual product approval.

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.

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: 5.9 ml 7.5 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
85455-0100-01 You're viewing this Main listing 100 mL in 1 TUBE 2025-04-09 — Active
85455-0100-61 85455-100-61 7.5 mL in 1 PACKET 2025-04-09 — Active
85455-0100-62 85455-100-62 5.9 mL in 1 PACKET 2025-04-09 — Active

Pack size FAQ

What quantity is in this package?
This package contains 100 mL — 100 ml in 1 tube.
How does this package differ from NDC 85455-0100-62?
Both are burnd Homosalate, Octinoxate, Zinc Oxide 8 g/100mL; 7.5 g/100mL; 8.1 g/100mL Lotion — the drug itself is identical. This page's package is the 100 mL one, while NDC 85455-0100-62 is the 5.9 ml package.
What NDC number is used to bill for this package of burnd Homosalate, Octinoxate, Zinc Oxide 8 g/100mL; 7.5 g/100mL; 8.1 g/100mL Lotion?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
burnd 8 g/100mL; 7.5 g/100mL; 8.1 g/100mLthis 85455-0100-01 BURND 100 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

🏛️
2025
On the market since
Apr 2025
📍
2026
Currently FDA-listed
1 year 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.

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 I9PJ0O6294
    A modified starch derived from corn or potato starch with aluminum salt and octenylsuccinic acid added. It acts as a binder to hold tablet ingredients together and as a thickening agent in liquid formulations.
  • UNII QN83US2B0N
    Ascorbyl palmitate is a fat-soluble form of vitamin C used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down and becoming less stable over time.
  • UNII 2JDK5W22H4
    A silicone-based substance that reduces surface tension and helps distribute ingredients evenly throughout the formula. It serves as an emulsifier and anti-foaming agent in medications.
  • 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 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • 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 Z17H97EA6Y
    A plant-derived mild cleanser made from natural sugars and oils. It acts as an emulsifier and surfactant to help mix water and oil-based ingredients together in the medicine.
  • UNII U9LS47Q72Q
    A synthetic oily liquid used as a plasticizer and solvent in pharmaceutical coatings and film formulations. It makes coatings flexible and helps active ingredients dissolve or disperse properly in the finished tablet or capsule.
  • UNII 9E4CO0W6C5
    A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
  • 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 ZF94AP8MEY
    Hydrogenated castor oil is a processed plant oil made by adding hydrogen to castor oil. It's used as a binder to help hold tablet ingredients together and as a lubricant to prevent sticking during manufacturing.
  • UNII N8F53B3R4R
    A synthetic humectant and solvent derived from propane. It draws and holds moisture in the formulation, helping keep the medicine stable and improving texture or flow in liquid and semi-solid products.
  • UNII 9713Q0S7FO
    A synthetic emulsifier derived from polyethylene glycol and fatty acids. It helps blend water and oil-based ingredients together in the formulation, improving texture and stability.
  • UNII 06R6X77P9C
    A silicone-based lubricant made by combining polyethylene glycol, polypropylene glycol, and dimethicone. It reduces friction and stickiness in tablet or capsule formulations to improve manufacturing and swallowing.
  • 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • 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.

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

The official label also statesAluminum Starch Octenylsuccinate,Ascorbyl Palmitate, Bis-PEG-12 Dimethicone Beeswax,Caprylhydroxamic Acid, Caprylyl Glycol, Cyclopentasiloxane,Decyl Glucoside, Diethylhexyl Sebacate, Ethylhexylglycerin,Hydrogenated Castor Oil, Methylpropanediol, PEG/PPG-20/15 Dimethicone, PEG-30 Dipolyhydroxystearate,Polysilicone-11, Propanediol, Silica, Sodium Chloride,Tocopheryl Acetate, Triethoxycaprylylsilane, Water (Aqua)

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.

Manufacturer & labeler

LabelerBURND LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code85455
First marketedApr 2025
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.

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 ▾

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 98 words ▾

Directions: Apply liberally 15 minutes before sun exposure. • 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 ofskin 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. to 2 p.m.

Wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months of age: Ask a doctor.

⚠️ Warnings 41 words ▾

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.

🧪 Active Ingredient 10 words ▾

Active Ingredients Homosalate 8.0 % Octinoxate 7.5% Zinc Oxide 8.1%

🧪 Inactive Ingredients 32 words ▾

Inactive Ingredients: Aluminum Starch Octenylsuccinate,Ascorbyl Palmitate, Bis-PEG-12 Dimethicone Beeswax,Caprylhydroxamic Acid, Caprylyl Glycol, Cyclopentasiloxane,Decyl Glucoside, Diethylhexyl Sebacate, Ethylhexylglycerin,Hydrogenated Castor Oil, Methylpropanediol, PEG/PPG-20/15 Dimethicone, PEG-30 Dipolyhydroxystearate,Polysilicone-11, Propanediol, Silica, Sodium Chloride,Tocopheryl Acetate, Triethoxycaprylylsilane, Water (Aqua)

🎯 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 ↗

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 BURND 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 5.9 ml (85455-0100-62), 7.5 ml (85455-0100-61). 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?
BURND 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.
← 85454-0421-01 · Syka 85456-0001-01 · Porphose →
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.