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Tinted Mineral Sunscreen SPF 50 Zinc Oxide and Titanium Dioxide 110 mg/g; 75 mg/g Lotion, 99 g — NDC 51326-0123-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tinted Mineral Sunscreen SPF 50 Zinc Oxide and Titanium Dioxide 110 mg/g; 75 mg/g Lotion, 99 g — NDC 51326-123-03 (Billing 51326-0123-03)

by Topiderm, Inc. · 99 g in 1 BOTTLE

This is a package of 99 g of Tinted Mineral Sunscreen SPF 50 Zinc Oxide and Titanium Dioxide 110 mg/g; 75 mg/g Lotion from Topiderm, Inc., marketed since Nov 2020 and currently FDA-listed. It is this product's only package size.

NDC 51326-0123-03
🏷️ FDA NDC (as labeled) 51326-123-03 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 51326-123-03 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
51326 labeler · 123 product · 03 package
Package marketed since
Nov 10, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5132612303 5
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51326-123-03
Product NDC 51326-123
11-digit billing NDC 51326012303
UNII SOI2LOH54Z, 15FIX9V2JP
Application # M020
SPL Set ID 13e5085f-df2b-46b2-b063-e58ce4379905
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-11-10
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 51326-123-03 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 51326-0123-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

🧪 What is this product?

This is a tinted mineral sunscreen lotion applied to the skin to help protect against sunburn. It contains two mineral UV filters, zinc oxide and titanium dioxide, which work by reflecting and scattering ultraviolet light away from the skin. The product is marketed as an over-the-counter sunscreen under FDA's established rules for sunscreen drugs, not as an individually reviewed application. SPF 50 indicates the level of UVB protection this lotion is formulated to provide.

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
51326-0123-03 You're viewing this Main listing 99 g in 1 BOTTLE 2020-11-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tinted Mineral Sunscreen SPF 50 110 mg/g; 75 mg/gthis 51326-0123-03 Topiderm, 99 g — — FDA listed —
Clarity Rx Physical Skin Defense SPF 50 110 mg/g; 75 mg/g 51326-0035-01 Topiderm, 99 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

🏛️
2020
On the market since
Nov 2020
📍
2026
Currently FDA-listed
6 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 LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered 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 3G6A5W338E
    Caffeine is a natural stimulant compound commonly extracted from coffee beans and tea leaves. In medicines, it serves as an active booster in pain relievers and cold products to enhance alertness and improve the effectiveness of other ingredients.
  • UNII 921FTA1500
    A synthetic compound derived from cetyl alcohol and ethylene oxide. It acts as an emulsifier and solubilizer to help blend oil and water components together in liquid formulations.
  • 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 1O6C93RI7Z
    Dexpanthenol is a naturally derived compound related to B vitamins. It acts as a humectant and skin conditioning agent, helping the medicine absorb moisture and maintain softness in topical formulations.
  • UNII 2V6E5WN99N
    A lipid compound made from fatty acids, used as an emulsifier and stabilizer in medicines to help mix oil and water-based ingredients and keep them from separating.
  • 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 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 YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII S4V5BS6GCX
    A synthetic oily liquid used as an emollient and solvent in topical medications. It helps dissolve active ingredients and creates a smooth, spreadable texture on the skin.
  • 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 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 8Q0Z18J1VL
    A surfactant derived from oleic acid, a naturally occurring fatty acid. It helps mix oil and water-based ingredients together in formulations, improving product stability and texture.
  • UNII TYP81E471F
    A silicone-based lubricant and anti-foaming agent derived from dimethicone, a synthetic polymer. It helps reduce friction during tablet or capsule manufacturing and prevents excessive foam in liquid formulations.
  • 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 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 1DXE3F3OZX
    A synthetic polymer that forms a gel-like network. It absorbs and holds water, thickens the medicine, and helps keep ingredients evenly mixed throughout the formulation.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 8T460WDH89
    A silane compound used as a coupling agent and adhesion promoter in pharmaceutical coatings and tablet formulations. It helps bind coating materials to tablet surfaces and improves the stability of film coatings.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesPurified Water, Dimethicone, Methyl Trimethicone, Isononyl Isononanoate, Oleth-3 Phosphate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Alumina, Butylene Glycol, Octyldodecyl Neopentanoate, VP/Eicosene Copolymer, Sodium Hyaluronate, Tocopheryl Acetate, Caffeine, Polyisobutene, Iron Oxides, Sucrose, Glycerin, Silicone, Isopropyl Titanium Triisostearate, Polysorbate 20, Polyacrylate-13, Panthenol, Cetearyl Alcohol, Dicetyl Phosphate, Ceteth-20 Phosphate, PEG-8 Methyl Ether Triethoxysilane, Hydrogen Dimethicone Polyglyceryl-6 Polyricinoleate, Xanthan Gum, Sodium Hydroxide, Phenoxyethanol, Disodium EDTA.

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

LabelerTopiderm, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code51326
First marketedNov 2020
Product typeHuman Otc Drug
Portfolio47 products on file

More NDCs from Topiderm, Inc. labeler code 51326

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 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 45 words ▾

Directions Apply liberally to face and neck and spread evenly 15 minutes before sun exposure Re-apply after swimming, excessive perspiring, or anytime after towel drying Use a water resistant sunscreen if swimming or sweating Use on children under 6 months of age: consult a doctor.

⚠️ Warnings 113 words ▾

Warnings For external use only. When using this product keep out of eyes, rinse with water to remove. Stop use if signs of irritation or rash appear.

If irritation or rash persists consult a doctor. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

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 of 15 or higher and other sunscreen measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses

🧪 Active Ingredient 11 words ▾

Active ingredient Purpose Zinc Oxide 11% Sunscreen Titanium Dioxide 7.5% Sunscreen

🧪 Inactive Ingredients 60 words ▾

Inactive ingredients Purified Water, Dimethicone, Methyl Trimethicone, Isononyl Isononanoate, Oleth-3 Phosphate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Alumina, Butylene Glycol, Octyldodecyl Neopentanoate, VP/Eicosene Copolymer, Sodium Hyaluronate, Tocopheryl Acetate, Caffeine, Polyisobutene, Iron Oxides, Sucrose, Glycerin, Silicone, Isopropyl Titanium Triisostearate, Polysorbate 20, Polyacrylate-13, Panthenol, Cetearyl Alcohol, Dicetyl Phosphate, Ceteth-20 Phosphate, PEG-8 Methyl Ether Triethoxysilane, Hydrogen Dimethicone Polyglyceryl-6 Polyricinoleate, Xanthan Gum, Sodium Hydroxide, Phenoxyethanol, Disodium EDTA.

🎯 Purpose 11 words ▾

Active ingredient Purpose Zinc Oxide 11% Sunscreen Titanium Dioxide 7.5% Sunscreen

📄 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 17 words ▾

Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

📄 Package Label / Principal Display Panel 48 words ▾

PRINCIPAL DISPLAY PANEL - 99 g Bottle Label COMPLIMENTS OF TOPIX PHARMACEUTICALS, INC MULTI-TASKING Mineral Lightly Tinted Antioxidant Sunscreen SPF 50+ Broad Spectrum SPF 50+ Water Resistant 40 minutes Net wt. 3.5 oz. (99 g) Available Custom Branded 800.445.2595 [email protected] PRINCIPAL DISPLAY PANEL - 99 g Bottle Label

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 Zinc Oxide and Titanium Dioxide — the ingredient across all brands.

Top reported reactions

Burning Sensation1
Erythema1
Pain1
Urticaria1

Reporter sex

1 reports
Female · 100%

Serious outcomes

Disabling1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 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.

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 Topiderm, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Topiderm, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 51326-0122-20 · Topiderm, 51326-0125-05 · Topiderm, →
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.