Home › NDC Lookup › Ingredients › Avobenzone, Homosalate, Octisalate, Octo... › 43419-0085-19
Sulwhasoo UV Daily Cream Avobenzone, Homosalate, Octisalate, Octocrylene 3.6 g/40mL; 1.8 g/40mL; 1 g/40mL; 3.6 g/40mL Cream — NDC 43419-0085-19 package photo

Sulwhasoo UV Daily Cream Avobenzone, Homosalate, Octisalate, Octocrylene 3.6 g/40mL; 1.8 g/40mL; 1 g/40mL; 3.6 g/40mL Cream

by Amorepacific Corporation · 1 TUBE in 1 CARTON (43419-085-19) / 40 mL in 1 TUBE
NDC 43419-0085-19
🏷️ FDA NDC (as labeled) 43419-085-19 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) 43419-085-19
Product NDC 43419-085
11-digit billing NDC 43419008519
UNII V06SV4M95S, 4X49Y0596W, G63QQF2NOX, 5A68WGF6WM
Application # M020
SPL Set ID e00451d5-8433-c4e8-e053-2a95a90a6244
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-05-31
Route TOPICAL
Dosage form CREAM
Substance HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 43419-085-19 — 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 → 43419-0085-19. 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

LabelerAmorepacific Corporation
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code43419
First marketedMay 2022
Product typeHuman Otc Drug
Portfolio53 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 sunscreen marketed as an over-the-counter monograph product. It contains four UV-filtering ingredients: avobenzone, homosalate, octisalate, and octocrylene. These ingredients are commonly used together in sunscreen formulations to absorb and scatter ultraviolet radiation from the sun. The product is applied to the skin as a protective barrier against UV exposure.

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 5SL0G7R0OK
    A simple sugar made from corn or other plants, used in medicines as a filler and sweetener. It helps create the right texture and taste in tablets, powders, and liquid formulations.
  • UNII CUQ3A77YXI
    Panax ginseng root is a plant extract traditionally used in herbal preparations. In medications, it may serve as an active botanical ingredient or be included for flavoring and as a natural preservative or binder in formulations.
  • 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 K67N5Z1RUA
    A plant-derived surfactant made from natural sugars and fatty alcohols. It helps dissolve and mix ingredients evenly throughout the medicine, acting as an emulsifier and solubilizer in liquid formulations.
  • UNII B1K89384RJ
    A mixture of fatty alcohols derived from natural oils or fats, typically containing 14 to 22 carbon atoms. Used as an emollient, thickener, and emulsifier to improve texture and help blend oil and water components in 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 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 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 I445L28B12
    A silicone-based compound that acts as a lubricant and glidant in tablet and capsule formulations. It reduces friction between particles and on equipment surfaces, helping medicines flow smoothly during manufacturing and tablet compression.
  • UNII 9G1OE216XY
    Docosanol is a waxy, fatty alcohol derived from plant sources. It acts as an emollient and thickener in topical medicines, helping to soften the skin and improve product texture and stability.
  • 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 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 42B5YD8F0K
    A plant extract from licorice root used in traditional medicine. In formulations, it may serve as a flavoring agent, sweetener, or soothing ingredient to improve taste and texture.
  • UNII Y9H1V576FH
    Honey is a natural sweetener made by bees from flower nectar. In medicines, it adds sweetness to improve taste and may help soothe throat irritation in lozenges or syrups.
  • UNII AHG15J8AM0
    A plant extract from the white lily bulb used in traditional formulations. It may serve as a skin-conditioning agent or natural ingredient to support texture and consistency in topical or oral products.
  • UNII 61W322NLDV
    A plant extract from sacred lotus flowers. Used as a natural colorant, fragrance, or skin-conditioning agent in topical formulations.
  • UNII 3Z3866YW6P
    A plant extract from peony root used in traditional herbal formulations. It may function as a flavoring agent, natural colorant, or botanical ingredient to support the product's herbal composition.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII KPF03O64AZ
    A plant extract from Solomon's seal root. It may be used as a natural flavoring agent, fragrance component, or traditional ingredient in herbal formulations.
  • UNII YR8AQ94O31
    A synthetic rubber polymer used as a binder and thickening agent in tablets and capsules. It helps hold ingredients together and may be used to control how quickly the medicine releases in your body.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII 03KCY6P7UT
    A waxy compound derived from cetyl alcohol and phosphoric acid. It acts as an emulsifier to help blend oil and water ingredients, and as a thickener to give the medicine its proper texture and consistency.
  • UNII 1BEM3U6LQQ
    A plant extract from rehmannia root, traditionally used in herbal medicine. In pharmaceutical products, it may serve as an active botanical ingredient or functional additive, though its specific role depends on the formulation type.
  • 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 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 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 25LXE464L2
    A silicone-based polymer used as a glidant and anti-caking agent in solid dosage forms. It reduces friction between particles and prevents clumping, helping powders flow smoothly during manufacturing and tablet compression.
  • UNII 9G1ZW13R0G
    A silicone-based polymer that reduces surface tension and improves how liquid medicines spread and are absorbed. It acts as a wetting agent and surfactant in topical formulations.
  • UNII 035MV9S1C3
    A plastic-like polymer made from two chemical compounds joined together. It acts as a binder and film-former in tablets and capsules, helping hold ingredients together and create a protective coating on the medicine's surface.
  • 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.

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

The official label also statesWater, Butylene Glycol, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Phenyl Trimethicone, Cyclohexasiloxane, Glycyrrhiza Uralensis (Licorice) Root Extract, 1,2-hexanediol, Camellia Sinensis Leaf Extract, Glyceryl Stearate, Panax Ginseng Root Extract, PEG-100 Stearate, Methoxy PEG-114/polyepsilon Caprolactone, Cetearyl Alcohol, Cetyl Alcohol, Aluminum Stearate, Polyhydroxystearic Acid, PEG-40 Stearate, Alumina, Phenoxyethanol, Fragrance, Hydroxyethyl Acrylate/ sodium Acryloyldimethyl Taurate Copolymer, Polyacrylate-13, Polygonatum Officinale Rhizome/root Extract, Rehmannia Glutinosa Root Extract, Lilium Tigrinum Flower/leaf/stem Extract, Paeonia Albiflora Root Extract, Nelumbo Nucifera Seed Extract, Stearic Acid, Chrysanthemum Morifolium Flower Extract, Citrus Unshiu Peel Extract, Xanthan Gum, Polyisobutene, Coix Lacryma-jobi Ma-yuen Seed Extract, Adenophora Stricta Root Extract, Glycerin, Ophiopogon Japonicus Root Extract, Honey, Carbomer, Polymethyl Methacrylate, Machilus Thunbergii Bark Extract, Ethylhexylglycerin, Paeonia Suffruticosa Root Extract, Lycium Chinense Root Extract, Propanediol, Angelica Tenuissima Root Extract, Disodium EDTA, Polysorbate 20, Silica, Natto Gum, Dimethicone, Beta-glucan, Triethoxycaprylylsilane, Myristic Acid, Stearyl Behenate, Polyglyceryl-3 Methylglucose Distearate, Hydroxypropyl Bispalmitamide MEA, Inulin Lauryl Carbamate

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
Sulwhasoo UV Daily Cream 3.6 g/40mL; 1.8 g/40mL; 1 g/40mL; 3.6 g/40mLthis 43419-0085-19 Amorepacific 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

🏛️
2022
On the market since
May 2022
📍
2026
Currently FDA-listed
4 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
43419-0085-19 You're viewing this 1 TUBE in 1 CARTON (43419-085-19) / 40 mL in 1 TUBE 2022-05-31 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 43419-085-19, 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: 43419-0085-19, written without dashes as 43419008519. 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 43419-0085-19, the first segment (43419) is the labeler code FDA assigned to Amorepacific Corporation; the middle segment (0085) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (19) 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 Amorepacific Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Amorepacific Corporation 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 30 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 92 words ▾

Direction Apply liberally 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor. 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.

⚠️ Warnings 35 words ▾

Warnings For external use only Do not use on damanged 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.

📦 Storage and Handling 41 words ▾

Other information Protect the product in this container from excessive heat and direct sun. Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

🧪 Active Ingredient 10 words ▾

ACTIVE INGREDIENTS Avobenzone 2.5% Homosalate 9.0% Octisalate 4.5% Octocrylene 9.0%

🧪 Inactive Ingredients 145 words ▾

Inactive ingredients Water, Butylene Glycol, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Phenyl Trimethicone, Cyclohexasiloxane, Glycyrrhiza Uralensis (Licorice) Root Extract, 1,2-hexanediol, Camellia Sinensis Leaf Extract, Glyceryl Stearate, Panax Ginseng Root Extract, PEG-100 Stearate, Methoxy PEG-114/polyepsilon Caprolactone, Cetearyl Alcohol, Cetyl Alcohol, Aluminum Stearate, Polyhydroxystearic Acid, PEG-40 Stearate, Alumina, Phenoxyethanol, Fragrance, Hydroxyethyl Acrylate/ sodium Acryloyldimethyl Taurate Copolymer, Polyacrylate-13, Polygonatum Officinale Rhizome/root Extract, Rehmannia Glutinosa Root Extract, Lilium Tigrinum Flower/leaf/stem Extract, Paeonia Albiflora Root Extract, Nelumbo Nucifera Seed Extract, Stearic Acid, Chrysanthemum Morifolium Flower Extract, Citrus Unshiu Peel Extract, Xanthan Gum, Polyisobutene, Coix Lacryma-jobi Ma-yuen Seed Extract, Adenophora Stricta Root Extract, Glycerin, Ophiopogon Japonicus Root Extract, Honey, Carbomer, Polymethyl Methacrylate, Machilus Thunbergii Bark Extract, Ethylhexylglycerin, Paeonia Suffruticosa Root Extract, Lycium Chinense Root Extract, Propanediol, Angelica Tenuissima Root Extract, Disodium EDTA, Polysorbate 20, Silica, Natto Gum, Dimethicone, Beta-glucan, Triethoxycaprylylsilane, Myristic Acid, Stearyl Behenate, Polyglyceryl-3 Methylglucose Distearate, Hydroxypropyl Bispalmitamide MEA, Inulin Lauryl Carbamate

🎯 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 ↗
← 43419-0079-31 · Amorepacific 43419-0086-31 · Amorepacific →
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.