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TiZO Mineral Sun Defense SPF 50 Titanium Dioxide, Zinc Oxide 100 mg/g; 30 mg/g Cream — NDC 58892-0128-50 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

TiZO Mineral Sun Defense SPF 50 Titanium Dioxide, Zinc Oxide 100 mg/g; 30 mg/g Cream — NDC 58892-128-50 (Billing 58892-0128-50)

by Fallien Cosmeceuticals Ltd. · 1 TUBE in 1 CARTON / 50 g in 1 TUBE

This is a package of TiZO Mineral Sun Defense SPF 50 Titanium Dioxide, Zinc Oxide 100 mg/g; 30 mg/g Cream from Fallien Cosmeceuticals Ltd., marketed since Mar 2023 and currently FDA-listed.

NDC 58892-0128-50
🏷️ FDA NDC (as labeled) 58892-128-50 billing pads the product segment with a zero
This package
Contains50 g in 1 tube Pack sizes3 compare ↓
Product page 58892-0128-05 Also comes in: 1.5 g 58892-128-15 5 g 58892-128-05
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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 58892-128-50 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
58892 labeler · 128 product · 50 package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0358892128051
FDA record last changed
Oct 1, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58892-128-50
Product NDC 58892-128
11-digit billing NDC 58892012850
UNII 15FIX9V2JP, SOI2LOH54Z
UPC 0358892128051
Application # M020
SPL Set ID e17a8c35-2d49-4c99-b154-ea673c14753e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-03-01
Route TOPICAL
Dosage form CREAM
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 58892-128-50 — 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 → 58892-0128-50. 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?

TiZO Mineral Sun Defense SPF 50 is a topical cream sunscreen sold over the counter under FDA's OTC monograph rules. It contains two mineral-based active ingredients, titanium dioxide and zinc oxide, which function as physical UV filters. These ingredients work by sitting on the skin surface to reflect and scatter ultraviolet rays away from the skin. This type of sunscreen is commonly used to help protect skin from sun 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.

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.
Try another pack size: 1.5 g 5 g
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
58892-0128-50 You're viewing this 1 TUBE in 1 CARTON / 50 g in 1 TUBE 2023-03-01 — Active
58892-0128-15 58892-128-15 1.5 g in 1 PACKET 2023-03-01 — Active
58892-0128-05 58892-128-05 Main listing 5 g in 1 TUBE Sample 2023-03-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 50 g in 1 tube.
What NDC number is used to bill for this package of TiZO Mineral Sun Defense SPF 50 Titanium Dioxide, Zinc Oxide 100 mg/g; 30 mg/g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Matte Shield SPF 100 mg/g; 30 mg/g 85291-0258-50 ACNE 53 g — — FDA listed —
Shunly Natural Cover SPF50 100 mg/g; 30 mg/g 81381-0258-50 Shunly 53 g — — FDA listed —
Daily Tinted Mineral SPF 100 mg/g; 30 mg/g 85296-0258-50 Skin 50 g — — FDA listed —
Sunshade Daily Sun Defense 100 mg/g; 30 mg/g 85730-0258-50 BELLAGENA 53 g — — FDA listed —
TiZO Mineral Sun Defense SPF 50 100 mg/g; 30 mg/gthis 58892-0128-50 Fallien 1 tube — — FDA listed —
Tinted Daily Mineral Sunscreen 100 mg/g; 30 mg/g 85508-0258-50 RSL89 53 g — — FDA listed —
Daily Defense Tinted Mineral Sunscreen 100 mg/g; 30 mg/g 85691-0258-50 LEDUC, 53 g — — FDA listed —
Essential Mineral Sun Protection 100 mg/g; 30 mg/g 85387-0258-50 Fern 53 g — — FDA listed —
Daily Defense Tinted Mineral Sunscreen 100 mg/g; 30 mg/g 85672-0258-50 JKH 50 g — — FDA listed —
Sheer Satin Mineral Sunscreen Tinted 100 mg/g; 30 mg/g 85306-0258-50 INTEGRATIVE 53 g — — FDA listed —
Daily Sun Defense 100 mg/g; 30 mg/g 85698-0258-50 LIV 53 g — — FDA listed —
SPF 50 Mineral Based Facial Sunscreen 100 mg/g; 30 mg/g 81679-0258-50 Hutton, 53 g — — FDA listed —
Tinted Mineral Sunscreen 100 mg/g; 30 mg/g 85645-0258-50 LEILANI 53 g — — 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

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 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.

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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII 4ZR792I587
    Bismuth oxychloride is a white powder derived from bismuth metal. In medicines, it's used mainly as a colorant and opacifying agent to give tablets or capsules their appearance and to make liquid formulations less transparent.
  • UNII UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • 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 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 XHK3U310BA
    Cyclohexasiloxane is a silicon-based liquid that acts as a solvent and conditioning agent in medicines. It helps dissolve or carry other ingredients and improves how the product spreads or feels on the skin.
  • 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 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • UNII 3W8F25684B
    A synthetic ester derived from stearic acid, used primarily as an emollient and binder in topical formulations. It helps soften and smooth the product texture while improving how ingredients blend together.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • 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 A8289P68Y2
    Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
  • UNII 918X1OUF1E
    Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
  • 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 YF70189L0N
    Melissa officinalis, commonly known as lemon balm, is a plant extract used as a flavoring and aromatic ingredient in medicines. It adds a mild lemon scent and taste to improve palatability.
  • UNII V8A1AW0880
    Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
  • UNII XOF597Q3KY
    A refined form of wax made from petroleum, microcrystalline wax is used in medicines as a coating agent, binder, and hardening ingredient. It helps give tablets and capsules their shape and protective outer layer.
  • UNII X8725R883T
    A synthetic oily liquid derived from branched carboxylic acids, used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product's texture while improving how it spreads on skin.
  • UNII 9713Q0S7FO
    A synthetic emulsifier derived from polyethylene glycol and fatty acids. It helps blend water and oil-based ingredients together in the formulation, improving texture and stability.
  • UNII YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 9LBV3F07AZ
    A synthetic, oil-soluble form of vitamin C used as an antioxidant to prevent degradation of the medicine and maintain its stability during storage.
  • 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 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 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • 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.

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

The official label also statesBismuth Oxychloride, Capric/Caprylic Triglyceride, Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides, Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint) Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate, PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine, Triethoxycaprylylsilane, Water

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

LabelerFallien Cosmeceuticals Ltd.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code58892
First marketedMar 2023
Product typeHuman Otc Drug
Portfolio4 products on file

More NDCs from Fallien Cosmeceuticals Ltd. labeler code 58892

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 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 91 words ▾

Directions: Apply liberally 15 minutes before sun exposure. Reapply: After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Children under 6 months: Ask a doctor 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 am-2 pm Wear long-sleeved shirts, pants, hats, and sunglasses

⚠️ Warnings 55 words ▾

Warnings: For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 8 words ▾

Active Ingredients: Titanium Dioxide 10% Zinc Oxide 3%

🧪 Inactive Ingredients 46 words ▾

Inactive Ingredients: Bismuth Oxychloride, Capric/Caprylic Triglyceride, Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides, Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint) Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate, PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine, Triethoxycaprylylsilane, Water

🎯 Purpose 3 words ▾

Purpose Sunscreen Sunscreen

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin.

📄 When Using This Product 13 words ▾

When using this product, keep out of eyes. Rinse with water to remove.

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask a doctor if rash occurs.

📄 Keep Out of Reach of Children 27 words ▾

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

Keep out of the reach of children.

📄 Other Information 15 words ▾

Other Information: Protect this product from excessive heat and direct sun May stain some fabrics

📄 Package Label / Principal Display Panel 50 words ▾

Principal Display Panel – 50 g Carton Label TiZO ® MINERAL SUN DEFENSE Tinted SPF 50 DAILY MINERAL SUNSCREEN Photoaging Defense Titanium & Zinc Oxides Antioxidants C & E Broad Spectrum SPF 50 Water Resistant (40 Minutes) Net Wt.

1.75Oz./50 g Principal Display Panel – 50 g Carton Label

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

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 Fallien Cosmeceuticals Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1.5 g (58892-0128-15), 5 g (58892-0128-05). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Fallien Cosmeceuticals 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.
← 58892-0124-45 · Fallien 58892-0131-50 · Fallien →
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.