Home › NDC Lookup › Ingredients › Avobenzone Homosalate Octisalate Octocry... › 81165-0001-03
Wellage Real Hyaluronic Watery Glow Sun Screen Avobenzone, Homosalate, Octisalate, Octocrylene 3.5 g/50mL; 2.25 g/50mL; 1.425 g/50mL; 4.5 g/50mL Cream — NDC 81165-0001-03 package photo

Wellage Real Hyaluronic Watery Glow Sun Screen Avobenzone, Homosalate, Octisalate, Octocrylene 3.5 g/50mL; 2.25 g/50mL; 1.425 g/50mL; 4.5 g/50mL Cream

by Hugel, Inc. · 2 BOX in 1 BOX (81165-001-03) / 1 BOTTLE, PLASTIC in 1 BOX (81165-001-02) / 50 mL in 1 BOTTLE, PLASTIC (81165-001-01)
NDC 81165-0001-03
🏷️ FDA NDC (as labeled) 81165-001-03 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) 81165-001-03
Product NDC 81165-001
11-digit billing NDC 81165000103
UNII V06SV4M95S, 4X49Y0596W, G63QQF2NOX, 5A68WGF6WM
Application # M020
SPL Set ID 37aa2f7b-afa4-5cc9-e063-6294a90ae741
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-22
Route TOPICAL
Dosage form CREAM
Substance HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 81165-001-03 — 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 → 81165-0001-03. 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

LabelerHugel, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code81165
First marketedJun 2025
Product typeHuman Otc Drug
Portfolio3 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?

Wellage Real Hyaluronic Watery Glow Sun Screen is a topical cream marketed as an over-the-counter sunscreen product under FDA's OTC monograph rules. It contains four UV-filtering active ingredients (avobenzone, homosalate, octisalate, and octocrylene) that are typically used together to absorb and scatter ultraviolet light from the sun. Products of this type are commonly applied to the skin to help reduce sun exposure. This listing does not represent an FDA-reviewed new drug application but rather a product formulated according to established OTC sunscreen regulations.

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 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
  • UNII 06S8147L47
    A synthetic liquid solvent derived from ethylene glycol and benzyl alcohol. It helps dissolve and stabilize active ingredients in liquid medicines, improving their uniform mixing and shelf stability.
  • 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 C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 58B69Q84JO
    A plant-derived emulsifier made from olive oil and fatty alcohols. It helps blend oil and water ingredients together and stabilizes the product's texture in creams, lotions, and similar formulations.
  • 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 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 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 TE7660XO1C
    Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
  • UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • 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 MBQ7DDQ7AR
    Hydroxyethyl urea is a synthetic organic compound used in medicines as a humectant and conditioning agent. It helps retain moisture in formulations and may improve texture or stability in topical products.
  • 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 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 452VLY9402
    Serine is an amino acid, a building block of proteins. In medications, it functions as a buffering agent and stabilizer to help maintain the product's pH balance and protect active ingredients during storage.
  • 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 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 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 MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • UNII 05Q7CD0E49
    A fatty acid derivative made from natural sugar and lauric acid. It acts as an emulsifier and solubilizer in medicines, helping mix water and oil-based ingredients together and improve how the body absorbs certain drugs.
  • 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.

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

The official label also statesWater, Butylene Glycol, Propanediol, Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Silica, 1,2-Hexanediol, Pentylene Glycol, Hydroxyethyl Urea, Cetearyl Olivate, Poly C10-30 Alkyl Acry- late, Sorbitan Olivate, Cetyl Alcohol, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Trometha- mine, Xanthan Gum, Ethylhexylglycerin, Glycerin, Hydrogenated Lecithin, Caprylic/Capric Trigly- ceride, Sodium Stearoyl Glutamate, Sucrose Laurate, Tocopherol, Arginine, Glycine, Histidine, Serine, Hydrolyzed Hyaluronic Acid, Lysolecithin, Benzyl Glycol, Hydrolyzed Glycosaminoglycans, Sodium Hyaluronate, Sodium Hyaluronate Cross- polymer, Hydroxypropyltrimonium Hyaluronate, Hyaluronic Acid, Sodium Acetylated Hyaluronate

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
Wellage Real Hyaluronic Watery Glow Sun Screen 3.5 g/50mL; 2.25 g/50mL; 1.425 g/50mL; 4.5 g/50mLthis 81165-0001-03 Hugel, 1 bottle — — 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
Jun 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
81165-0001-03 You're viewing this 2 BOX in 1 BOX (81165-001-03) / 1 BOTTLE, PLASTIC in 1 BOX (81165-001-02) / 50 mL in 1 BOTTLE, PLASTIC (81165-001-01) 2025-06-22 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 81165-001-03, 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: 81165-0001-03, written without dashes as 81165000103. 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 81165-0001-03, the first segment (81165) is the labeler code FDA assigned to Hugel, Inc.; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Hugel, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hugel, 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 31 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. 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 14 words ▾

Active ingredients Avobenzone 2.85 % Homosalate 7 % Octisalate 4.5 % Octocrylene 9 %

🧪 Inactive Ingredients 74 words ▾

Inactive ingredients Water, Butylene Glycol, Propanediol, Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Silica, 1,2-Hexanediol, Pentylene Glycol, Hydroxyethyl Urea, Cetearyl Olivate, Poly C10-30 Alkyl Acry- late, Sorbitan Olivate, Cetyl Alcohol, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Trometha- mine, Xanthan Gum, Ethylhexylglycerin, Glycerin, Hydrogenated Lecithin, Caprylic/Capric Trigly- ceride, Sodium Stearoyl Glutamate, Sucrose Laurate, Tocopherol, Arginine, Glycine, Histidine, Serine, Hydrolyzed Hyaluronic Acid, Lysolecithin, Benzyl Glycol, Hydrolyzed Glycosaminoglycans, Sodium Hyaluronate, Sodium Hyaluronate Cross- polymer, Hydroxypropyltrimonium Hyaluronate, Hyaluronic Acid, Sodium Acetylated Hyaluronate

🎯 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 ↗
← 81159-0504-00 · The 81165-0050-01 · Hugel, →
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.