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TONEfitSUN Ultra Moisturizing Vegan Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 9 g/100mL; 2.7 g/100mL; 13.5 g/100mL; 4.5 g/100mL Cream, 50 mL — NDC 58544-0150-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

TONEfitSUN Ultra Moisturizing Vegan Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 9 g/100mL; 2.7 g/100mL; 13.5 g/100mL; 4.5 g/100mL Cream, 50 mL — NDC 58544-150-02 (Billing 58544-0150-02)

by Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory · 1 CONTAINER in 1 CARTON / 50 mL in 1 CONTAINER

This is a package of 50 mL of TONEfitSUN Ultra Moisturizing Vegan Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 9 g/100mL; 2.7 g/100mL; 13.5 g/100mL; 4.5 g/100mL Cream from Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory, marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.

NDC 58544-0150-02
🏷️ FDA NDC (as labeled) 58544-150-02 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 58544-150-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
58544 labeler · 150 product · 02 package
Package marketed since
Mar 1, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5854415002 7
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58544-150-02
Product NDC 58544-150
11-digit billing NDC 58544015002
UNII 5A68WGF6WM, G63QQF2NOX, V06SV4M95S, 4X49Y0596W
Application # M020
SPL Set ID 4ec58c23-16b1-03bb-e063-6394a90a46c0
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-01
Route TOPICAL
Dosage form CREAM
Substance OCTOCRYLENE; AVOBENZONE; HOMOSALATE; OCTISALATE
Why two NDCs? The FDA registers this code as 58544-150-02 — 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 → 58544-0150-02. 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.

Clinical

🧪 What is this product?

TONEfitSUN Ultra Moisturizing Vegan Sunscreen is a topical cream containing four UV-filter ingredients: avobenzone, homosalate, octisalate, and octocrylene. These ingredients are commonly used together in sunscreen products to absorb and scatter ultraviolet radiation. This is an over-the-counter monograph drug, meaning it is marketed under established FDA guidelines for sunscreen products rather than as an individually reviewed 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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
58544-0150-02 You're viewing this Main listing 1 CONTAINER in 1 CARTON / 50 mL in 1 CONTAINER 2026-03-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
TONEfitSUN Ultra Moisturizing Vegan Sunscreen 9 g/100mL; 2.7 g/100mL; 13.5 g/100mL; 4.5 g/100mLthis 58544-0150-02 Hankook 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

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 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 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 F4K100DXP3
    Dibutyl adipate is a synthetic oily liquid derived from adipic acid. It serves as a plasticizer and solvent in medicines, helping softens coatings and improves flexibility so tablets and capsules don't crack or break.
  • 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 KFR5QEN0N9
    A synthetic plastic polymer that helps form a protective film coating on the medicine. It's used as a binder and film-former to hold the tablet or capsule together and control how quickly the drug dissolves.
  • 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.

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

The official label also statesInactive Ingredients Water(Aqua), Dibutyl Adipate, Butyloctyl Salicylate, Propanediol, VP/Hexadecene Copolymer, 1,2-Hexanediol, Polymethylsilsesquioxane, Coco-Caprylate/Caprate, Panthenol, Poly C10-30 Alkyl Acrylate, Cetearyl Alcohol, Polyglyceryl-3 Distearate, Methyl Methacrylate Crosspolymer, Glyceryl Stearate, Potassium Cetyl Phosphate, Ammonium Polyacryloyldimethyl Taurate, Carbomer, Tromethamine, Glyceryl Stearate Citrate, Sodium Polyacryloyldimethyl Taurate, Tocopheryl Acetate, Ethylhexylglycerin, t-Butyl Alcohol

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

LabelerHankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code58544
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong... labeler code 58544

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 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 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 101 words ▾

Directions • 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 58 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 Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 10 words ▾

Active ingredients AVOBENZONE 2.7% HOMOSALATE 13.5% OCTISALATE 4.5% OCTOCRYLENE 9%

🧪 Inactive Ingredients 46 words ▾

Inactive Ingredients Water(Aqua), Dibutyl Adipate, Butyloctyl Salicylate, Propanediol, VP/Hexadecene Copolymer, 1,2-Hexanediol, Polymethylsilsesquioxane, Coco-Caprylate/Caprate, Panthenol, Poly C10-30 Alkyl Acrylate, Cetearyl Alcohol, Polyglyceryl-3 Distearate, Methyl Methacrylate Crosspolymer, Glyceryl Stearate, Potassium Cetyl Phosphate, Ammonium Polyacryloyldimethyl Taurate, Carbomer, Tromethamine, Glyceryl Stearate Citrate, Sodium Polyacryloyldimethyl Taurate, Tocopheryl Acetate, Ethylhexylglycerin, t-Butyl Alcohol

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Other Information 12 words ▾

Other Information • Protect this product from excessive heat and direct sun

📄 Package Label / Principal Display Panel 2 words ▾

carton image

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 TONEfitSUN Ultra Moisturizing Vegan Sunscreen (this brand).

Top reported reactions

Acute Myeloid Leukaemia2
Exposure To Toxic Agent2
Product Contamination Chemical2
Rash2
Anaphylactic Reaction1
Application Site Erythema1
Application Site Exfoliation1

Age at onset

Adolescent2
Adult1

Reporter sex

6 reports
Male · 20%
Female · 80%
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 2 1
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.

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 Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory 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.
← 58518-0040-02 · Avasol 58544-0160-02 · Hankook →
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.