ISNTREE HYALURONIC ACID DAILY SUNGEL Avobenzone, Homosalate, Octisalate .9 g/10mL; .27 g/10mL; .45 g/10mL Cream — NDC 81100-0104-02 package photo

ISNTREE HYALURONIC ACID DAILY SUNGEL Avobenzone, Homosalate, Octisalate .9 g/10mL; .27 g/10mL; .45 g/10mL Cream

by ISNTREE Inc. · 1 TUBE in 1 BOX (81100-104-02) / 10 mL in 1 TUBE (81100-104-01)
NDC 81100-0104-02
🏷️ FDA NDC (as labeled) 81100-104-02 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 3, 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) 81100-104-02
Product NDC 81100-104
11-digit billing NDC 81100010402
UNII V06SV4M95S, G63QQF2NOX, 4X49Y0596W
Application # M020
SPL Set ID 5a3a17ff-a7fd-f707-e063-6394a90a3182
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-01-09
Route TOPICAL
Dosage form CREAM
Substance HOMOSALATE; AVOBENZONE; OCTISALATE
Why two NDCs? The FDA registers this code as 81100-104-02 — 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 → 81100-0104-02. 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

LabelerISNTREE Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code81100
First marketedJan 2025
Product typeHuman Otc Drug
Portfolio12 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?

This is a topical cream marketed as an over-the-counter sunscreen product under FDA's monograph rules for sun-protection agents. It contains three active ingredients: homosalate, avobenzone, and octisalate, which are ultraviolet (UV) light filters commonly used together in sunscreen formulations to help absorb and scatter UV radiation from the sun. The product is typically applied to skin to provide sun protection. This listing represents a category of products governed by the FDA's established rules for OTC sunscreen ingredients rather than individual product applications.

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 K72T3FS567
    Adenosine is a naturally occurring nucleoside compound. In medicines, it functions as an active pharmaceutical ingredient in some formulations, though when listed as an excipient it may serve as a buffering or stabilizing agent to maintain product stability and pH.
  • 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 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 O4M0347C6A
    C20-22 alcohols are fatty alcohols derived from natural oils or fats. They act as emulsifiers and thickeners in medicines, helping blend oil and water-based ingredients and give the product its desired texture.
  • UNII L4VKP0Y7RP
    A synthetic chemical compound derived from fatty acids with 20-22 carbon atoms, combined with phosphate. It functions as an emulsifier and surfactant to help mix oil and water-based ingredients evenly throughout the medicine.
  • UNII 4YS74Q4G4J
    A plant extract from Centella asiatica containing natural compounds called triterpenoids. It's used as an active ingredient in some formulations for its purported skin-supporting properties, though it functions as a botanical additive rather than a structural component of the medicine.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII I0DQJ7YGXM
    A synthetic chemical compound used as a plasticizer in pharmaceutical coatings. It makes film coatings more flexible and durable so they don't crack or peel during manufacturing and storage.
  • UNII Z853O1D4TE
    A silicone-based compound derived from hyaluronic acid, used as a skin-conditioning agent and emollient in topical formulations. It helps soften and smooth the product's texture while enhancing moisture retention on the skin's surface.
  • UNII E107L85C40
    Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 7GXZ3858RY
    Ectoine is a naturally derived protective compound used in pharmaceuticals as a stabilizer and humectant. It helps preserve the integrity of active ingredients and maintain moisture in formulations.
  • 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 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII RH041UUZ22
    A plant extract from the houttuynia cordata flower, traditionally used in Asian medicine. In formulations, it may serve as a natural flavoring, coloring, or active botanical ingredient carrier.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • 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 40KQ7Q535O
    A plant extract from white water lily flowers. It's used in formulations for its soothing and skin-conditioning properties, often included in topical products as a natural ingredient to enhance texture and feel.
  • 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 59Z907ZB69
    A synthetic silicone polymer used as a glidant and anti-caking agent. It reduces friction between particles, helping powders and tablets flow smoothly during manufacturing and use.
  • 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 M6S840WXG5
    Purslane is a plant-derived ingredient used in pharmaceuticals as a natural source of beneficial compounds. It functions as an antioxidant and anti-inflammatory agent to help stabilize the formula and support product shelf life.
  • 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 WN66R7GL93
    A modified form of hyaluronic acid, a naturally occurring substance that holds water. Used as a thickener, lubricant, and moisture-retaining agent in formulations, especially in topical or injectable products.
  • UNII 64L053FRFO
    Sodium palmitoyl proline is a synthetic compound made from the amino acid proline combined with palmitic acid (a fatty acid). It acts as an emulsifier and skin-conditioning agent in topical formulations, helping mix oil and water components and maintain product texture.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
  • 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.

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

The official label also statesWater, Butyloctyl Salicylate, Butylene Glycol, Diethylhexyl 2,6-Naphthalate, Niacinamide, C20-22 Alkyl Phosphate, C20-22 Alcohols, 1,2-Hexanediol, Pentylene Glycol, Acrylates Copolymer, Polymethylsilsesquioxane, Cetyl Alcohol, Poly C10-30 Alkyl Acrylate, VP/Eicosene Copolymer, Glyceryl Stearate, Silica, Tromethamine, Propanediol, Polyacrylate Crosspolymer-6, Xanthan Gum, Ethylhexylglycerin, Adenosine, Portulaca Oleracea Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Dimethylsilanol Hyaluronate, Hyaluronic Acid, Sodium Hyaluronate, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydroxypropyltrimonium Hyaluronate, Sodium Hyaluronate Dimethylsilanol, Sodium Acetylated Hyaluronate, Tocopherol, Ectoin, Dipropylene Glycol, Sodium Palmitoyl Proline, Glycerin, Beta-Glucan, Nymphaea Alba Flower Extract

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 DailyMedingredient 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
Isntree Hyaluronic Acid Daily Sungel .9 g/10mL; .27 g/10mL; .45 g/10mL 81100-0103-02 ISNTREE 1 tube FDA listed
Isntree Hyaluronic Acid Daily Sungel .9 g/10mL; .27 g/10mL; .45 g/10mLthis 81100-0104-02 ISNTREE 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

🏛️
2025
On the market since
Jan 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.

🔬 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 Avobenzone, Homosalate, Octisalate — the ingredient across all brands.

Top reported reactions

Skin Cancer65
Rash53
Pruritus37
Erythema29
Dyspnoea27
Malignant Melanoma27
Neoplasm Malignant27

Age at onset

Infant1
Child7
Adolescent5
Adult75
Elderly56

Reporter sex

760 reports

Serious outcomes

Hospitalization109
Disabling26
Death23
Life-threatening12
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 57 7
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
81100-0104-02 You're viewing this 1 TUBE in 1 BOX (81100-104-02) / 10 mL in 1 TUBE (81100-104-01) 2025-01-09 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 81100-104-02, 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: 81100-0104-02, written without dashes as 81100010402. 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 81100-0104-02, the first segment (81100) is the labeler code FDA assigned to ISNTREE Inc.; the middle segment (0104) 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 ISNTREE Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ISNTREE 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 40 words

Uses • helps prevent sunburn • higher SPF gives more sunburn protection • 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. 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 ■ reapply at least every 2 hours. ■ use a water-resistant sunscreen if swimming or sweating.

⚠️ Warnings 5 words

Warnings For external use only.

🧪 Active Ingredient 11 words

Active ingredients Avobenzone 2.7 % Homosalate 9 % Octisalate 4.5 %

🧪 Inactive Ingredients 87 words

Inactive ingredients Water, Butyloctyl Salicylate, Butylene Glycol, Diethylhexyl 2,6-Naphthalate, Niacinamide, C20-22 Alkyl Phosphate, C20-22 Alcohols, 1,2-Hexanediol, Pentylene Glycol, Acrylates Copolymer, Polymethylsilsesquioxane, Cetyl Alcohol, Poly C10-30 Alkyl Acrylate, VP/Eicosene Copolymer, Glyceryl Stearate, Silica, Tromethamine, Propanediol, Polyacrylate Crosspolymer-6, Xanthan Gum, Ethylhexylglycerin, Adenosine, Portulaca Oleracea Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Dimethylsilanol Hyaluronate, Hyaluronic Acid, Sodium Hyaluronate, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydroxypropyltrimonium Hyaluronate, Sodium Hyaluronate Dimethylsilanol, Sodium Acetylated Hyaluronate, Tocopherol, Ectoin, Dipropylene Glycol, Sodium Palmitoyl Proline, Glycerin, Beta-Glucan, Nymphaea Alba Flower Extract

🎯 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 ↗
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.