HomeNDC LookupIngredientsTitanium Dioxide Zinc Oxide › 83403-0101-02
BETA-GLUCAN MILD SUNSCREEN Titanium Dioxide, Zinc Oxide 10.08 g/100mL; 5.61 g/100mL Lotion — NDC 83403-0101-02 package photo

BETA-GLUCAN MILD SUNSCREEN Titanium Dioxide, Zinc Oxide 10.08 g/100mL; 5.61 g/100mL Lotion

by IUNIK Co., Ltd · 1 TUBE in 1 BOX (83403-101-02) / 60 mL in 1 TUBE (83403-101-01)
NDC 83403-0101-02
🏷️ FDA NDC (as labeled) 83403-101-02 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 →
⚠️
Other active recalls for Titanium Dioxide, Zinc Oxide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 3, 2024 — Microbial Contamination of Non-Sterile Product (Vivier Pharma, Inc.) · FDA recall D-0662-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 83403-101-02
Product NDC 83403-101
11-digit billing NDC 83403010102
UNII SOI2LOH54Z, 15FIX9V2JP
Application # M020
SPL Set ID 47d6ad8b-1081-ee21-e063-6294a90a0e63
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-07
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 83403-101-02 — 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 → 83403-0101-02. 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

LabelerIUNIK Co., Ltd
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code83403
First marketedJan 2026
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.

🩺 Clinical

🧪 What is this product?

This is a topical lotion sunscreen marketed as an over-the-counter monograph product. It contains titanium dioxide and zinc oxide, which are mineral-based ingredients typically used to reflect and scatter ultraviolet light away from the skin. These active ingredients function as physical sunscreen agents intended to help protect skin from sun exposure when applied topically.

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 5QB0T2IUN0
    Aluminum hydroxide is a white powder mineral compound used as an antacid ingredient in some formulations. It works as a buffer and pH regulator to help neutralize stomach acid in the medicine.
  • UNII 6UQO3086C7
    A beneficial microorganism used as a probiotic ingredient to support digestive health and promote beneficial gut bacteria balance in the formulation.
  • UNII 298PX4M11X
    A synthetic chemical compound that acts as an antioxidant, helping protect the medicine's active ingredients from degradation caused by light, heat, and oxygen during storage and shelf life.
  • 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 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 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 5THT33P7X7
    A waxy, lipid-like substance derived from animal or plant sources. It helps soften and moisturize the skin by acting as an emollient and skin-conditioning agent in topical medicines and creams.
  • UNII SF3LP91341
    A waxy, skin-like lipid that helps form protective barriers in creams and lotions. It's used as an emollient and skin-conditioning agent to improve texture and help the product spread smoothly.
  • UNII F1X8L2B00J
    A naturally derived fatty substance that helps bind and condition the product's texture. It works as an emollient and skin-conditioning agent in topical formulations, helping maintain moisture and smoothness.
  • UNII C04977SRJ5
    Ceramide NG is a naturally occurring lipid compound that helps form protective barriers in skin and cosmetic formulations. It functions as an emollient and skin-conditioning agent, helping products retain moisture and maintain smooth texture.
  • UNII 4370DF050B
    Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 97C5T2UQ7J
    Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better 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 2P2G24V6T9
    A silicone-based ingredient that acts as a glidant and lubricant to help powder particles flow smoothly during manufacturing and tablet compression. It reduces friction and prevents clumping in the final product.
  • 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 X687XDK09L
    A clay mineral processed to carry positive charges, used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed throughout the product.
  • 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 TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • UNII H1109Z9J4N
    A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
  • UNII EVX7NC9YVE
    A synthetic waxy compound derived from palmitic acid, used as a binder and hardening agent. It helps hold tablet or capsule ingredients together and provides texture to solid dosage forms.
  • UNII WEF51750MT
    A synthetic oil derived from branched fatty acids, used as an emollient and lubricant in topical formulations to soften the skin and improve product spreadability and texture.
  • UNII DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII S73ZQI0GXM
    Methyl trimethicone is a silicone-based lubricant and glidant used in tablets and capsules. It reduces friction between particles and equipment during manufacturing, helping the medicine flow smoothly and compress evenly.
  • UNII 5LKW3C543X
    A synthetic oily liquid derived from neopentyl glycol and heptanoic acid. It serves as an emollient and solvent in formulations, helping to dissolve or suspend active ingredients and improve the texture and spreadability of topical products.
  • UNII Q6X9CNN54X
    ODETIGLUCAN is a modified polysaccharide derived from yeast cell walls. It serves as an immune-supporting ingredient and film-former in pharmaceutical formulations.
  • UNII Y1MLS7E68X
    A plant extract from poppy flowers used as a natural colorant to give medicines red or pink hues. It may also serve as a flavoring agent in some formulations.
  • UNII GIN46U9Q2Q
    Phytosphingosine is a naturally derived fatty compound that helps stabilize and thicken skincare and cosmetic formulations. It works as an emollient and conditioning agent to improve texture and skin feel in topical products.
  • UNII Q1Q9P50WIY
    A plant extract from Korean pine leaves used as a natural coloring agent and antioxidant in medicines. It helps preserve the product and may contribute subtle color or flavor notes to the formulation.
  • UNII 9229XJ4V12
    A synthetic emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients in formulations, keeping them mixed and preventing separation.
  • UNII RLA2U05Z4Q
    A silicone-based compound that acts as an emulsifier and skin-conditioning agent in topical formulations. It helps blend oil and water components together and creates a smooth, protective texture on the skin's surface.
  • UNII 7J95K7ID2S
    A plant extract from the roots of Chinese skullcap, used as a natural coloring agent and to add mild flavor to medicines. It may also help preserve the product's stability.
  • 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 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 4938BNS0GU
    A fungal extract from tremella fuciformis, a jelly-like mushroom. It acts as a thickener, emulsifier, and skin-conditioning agent in topical formulations to improve texture and moisture retention.
  • 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 5041RX63GN
    A synthetic silicon-based polymer used as a glidant and anti-caking agent. It helps powder particles flow smoothly and prevents clumping during manufacturing and storage.
  • 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 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.

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

The official label also statesWater, Dimethicone, Butyloctyl Salicylate, Neopentyl Glycol Diheptanoate, Glycerin, Trisiloxane, Silica, Isotridecyl Isononanoate, Trimethylsiloxysilicate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Methyl Trimethicone, Isostearyl Polyglyceryl-3 Dimethicone, Disteardimonium Hectorite, Stearic Acid, Aluminum Hydroxide, Magnesium Sulfate, 1,2-Hexanediol, Benzotriazolyl Dodecyl p-Cresol, Triethoxycaprylylsilane, Polyglyceryl-2 Dipolyhydroxystearate, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Caprylyl Glycol, Hydroxypropyl Bispalmitamide MEA, Butylene Glycol, Pinus Densiflora Leaf Extract, Hydrogenated Lecithin, Bacillus Ferment, Cetearyl Alcohol, Beta-Glucan, Scutellaria Baicalensis Root Extract, Tremella Fuciformis Polysaccharide, Centella Asiatica Extract, Ceramide NP, Ceramide NG, Cholesterol, Phytosphingosine, Papaver Rhoeas Flower Extract, Ceramide AS, Ceramide AP, Ceramide EOP

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
Beta-Glucan Mild Sunscreen 10.08 g/100mL; 5.61 g/100mLthis 83403-0101-02 IUNIK 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

🏛️
2026
On the market since
Jan 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.

🔬 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 BETA-GLUCAN MILD SUNSCREEN (this brand).

Top reported reactions

Application Site Acne1
Application Site Hypersensitivity1
Application Site Vesicles1

Reporter sex

1 reports
Female · 100%

Serious outcomes

Hospitalization1
Reports over time (by year) — tap or hover for the count & year
2025 2026 1 0
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
83403-0101-02 You're viewing this 1 TUBE in 1 BOX (83403-101-02) / 60 mL in 1 TUBE (83403-101-01) 2026-01-07 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 83403-101-02, 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: 83403-0101-02, written without dashes as 83403010102. 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 83403-0101-02, the first segment (83403) is the labeler code FDA assigned to IUNIK Co., Ltd; the middle segment (0101) 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 IUNIK Co., Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
IUNIK Co., Ltd 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 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 92 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 56 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 product is swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 8 words

ACTIVE INGREDIENTS Titamiun Dioxide 5.61% Zinc Oxide 10.08%

🧪 Inactive Ingredients 87 words

INACTIVE INGREDIENTS Water, Dimethicone, Butyloctyl Salicylate, Neopentyl Glycol Diheptanoate, Glycerin, Trisiloxane, Silica, Isotridecyl Isononanoate, Trimethylsiloxysilicate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Methyl Trimethicone, Isostearyl Polyglyceryl-3 Dimethicone, Disteardimonium Hectorite, Stearic Acid, Aluminum Hydroxide, Magnesium Sulfate, 1,2-Hexanediol, Benzotriazolyl Dodecyl p-Cresol, Triethoxycaprylylsilane, Polyglyceryl-2 Dipolyhydroxystearate, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Caprylyl Glycol, Hydroxypropyl Bispalmitamide MEA, Butylene Glycol, Pinus Densiflora Leaf Extract, Hydrogenated Lecithin, Bacillus Ferment, Cetearyl Alcohol, Beta-Glucan, Scutellaria Baicalensis Root Extract, Tremella Fuciformis Polysaccharide, Centella Asiatica Extract, Ceramide NP, Ceramide NG, Cholesterol, Phytosphingosine, Papaver Rhoeas Flower Extract, Ceramide AS, Ceramide AP, Ceramide EOP

🎯 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.