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Mineral Mist SPF-50 TITANIUM DIOXIDE, ZINC OXIDE 3.4 g/100mL; 15.7 g/100mL Spray, 178 mL — NDC 73088-0107-16 package photo

Mineral Mist SPF-50 TITANIUM DIOXIDE, ZINC OXIDE 3.4 g/100mL; 15.7 g/100mL Spray, 178 mL

by TUBBY TODD · 178 mL in 1 BOTTLE (73088-107-16)
NDC 73088-0107-16
🏷️ FDA NDC (as labeled) 73088-107-16 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 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

⚠️
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) 73088-107-16
Product NDC 73088-107
11-digit billing NDC 73088010716
UNII 15FIX9V2JP, SOI2LOH54Z
Application # M020
SPL Set ID dca54a19-af25-ce47-e053-2a95a90a22db
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-04-14
Route TOPICAL
Dosage form SPRAY
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 73088-107-16 — 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 → 73088-0107-16. 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

LabelerTUBBY TODD
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code73088
First marketedApr 2022
Product typeHuman Otc Drug
Portfolio12 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

Mineral Mist SPF-50 is a topical spray sunscreen marketed as an over-the-counter monograph product. It contains two mineral-based UV filters: titanium dioxide and zinc oxide, which are commonly used to block or scatter ultraviolet radiation from the sun. This spray formulation is typically applied to the skin to help protect against sun exposure. The product is regulated under the FDA's established rules for sunscreen ingredients rather than as an individually approved drug 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.

🧪 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 105S6I733Z
    A natural oil extracted from chamomile and other plants. It acts as a fragrance and flavoring agent to improve the taste and smell of the medicine.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • 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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII A3N5ZCN45C
    Bentonite is a naturally occurring clay mineral used in medicines as a binder and absorbent. It helps hold tablet ingredients together and can absorb moisture or unwanted substances in the formulation.
  • UNII S347WMO6M4
    Beta-sitosterol is a plant-derived sterol (waxy substance from vegetable oils and seeds). In medicines, it acts as an emulsifier or thickening agent to help blend oil and water-based ingredients and improve texture.
  • 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 33822S0M40
    A mineral oil derived from petroleum containing long-chain hydrocarbons. It serves as a lubricant and glidant to help powder flow and prevent clumping during tablet manufacturing and packaging.
  • 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 K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • 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 ICS790225B
    A plant-derived cleaning agent made from coconut oil and glucose. It works as a surfactant and emulsifier to help mix oil and water-based ingredients together in the formulation.
  • UNII 609A3V1SUA
    A silky liquid derived from caprylic acid that acts as an emollient and solvent in formulations. It helps dissolve active ingredients and improves the spreadability and feel of lotions, creams, and topical products.
  • 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 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII IJV4LS383R
    A synthetic waxy ester made from fatty acids and alcohols, used as an emollient and emulsifier to help blend oil and water components together and soften the product texture.
  • 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 7666FJ0J9F
    A rosin-derived compound used as a film-coating agent and binder in tablets and capsules. It helps create a protective layer around the medication and improves tablet hardness.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII T9296U138P
    A synthetic polymer derived from polyester chemistry, modified with a cyanodiphenylpropenoyl cap. It serves as a film-former and binder in pharmaceutical formulations, helping create protective coatings on tablets or improving product consistency.
  • UNII YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • 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 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 R6Q3791S76
    Sodium gluconate is a salt derived from gluconic acid, a naturally occurring compound. In medicines, it functions as a buffering agent to help maintain stable pH and as a chelating agent that can bind minerals in formulations.
  • UNII 65A9F4P024
    A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
  • UNII 7QWM220FJH
    Squalene is a natural oil-like substance found in shark liver and some plants. It's used in medicines as an emulsifier to help mix oil and water-based ingredients together.
  • 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 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.

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

The official label also statesAloe Barbadensis Leaf Juice, Alumina, Bentonite, Beta-Sitosterol, Bisabolol, Butyloctyl Salicylate, C18-21 Alkane, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Citric Acid, Coco-Glucoside, Dicaprylyl Carbonate, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearoyl Stearate, Isononyl Isononanoate, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyester-8, Polyhydroxystearic Acid, Propanediol, Silica, Sodium Gluconate, Sodium Stearoyl Glutamate, Squalene, Tocopherol, 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.

💲 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 mLPer 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
Mineral Mist SPF-50 3.4 g/100mL; 15.7 g/100mLthis 73088-0107-16 TUBBY 178 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

🏛️
2022
On the market since
Apr 2022
📍
2026
Currently FDA-listed
4 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 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 Mineral Mist SPF-50 (this brand).

Top reported reactions

Application Site Acne1
Application Site Hypersensitivity1
Application Site Vesicles1

Reporter sex

0 reports
Female · 100%
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
73088-0107-16 You're viewing this 178 mL in 1 BOTTLE (73088-107-16) 2022-04-14 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 73088-107-16, 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: 73088-0107-16, written without dashes as 73088010716. 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 73088-0107-16, the first segment (73088) is the labeler code FDA assigned to TUBBY TODD; the middle segment (0107) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) 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 TUBBY TODD. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
TUBBY TODD is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 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 119 words ▾

DIRECTIONS • Spray liberally and spread evenly by hand 15 minutes before sun exposure. • Hold 4-6 inches away from skin to apply • Reapply -after 80 minutes of swimming or sweating -immediately after towel drying -at least every 2 hours • Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10am - 2pm -wear long-sleeve shirts, pants, hats and sunglasses • Do not spray product directly on face. • Children under 6 months of age: ask a doctor.

⚠️ Warnings 84 words ▾

WARNINGS • For external use only. • Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately. • Do not use on damage or broken skin. • When using this product • keep out of eyes. Rinse with water to remove. • keep away from face to avoid inhaling • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 ̊F. • Stop use and ask a doctor if skin rash occurs.

📦 Storage and Handling 28 words ▾

OTHER INFORMATION • Protect this product from excessive heat and direct sun • May stain some fabrics • Do not use if quality seal is broken or missing

🧪 Active Ingredient 8 words ▾

ACTIVE INGREDIENTS Titanium Dioxide 3.4% Zinc Oxide 15.7%

🧪 Inactive Ingredients 55 words ▾

INACTIVE INGREDIENT Aloe Barbadensis Leaf Juice, Alumina, Bentonite, Beta-Sitosterol, Bisabolol, Butyloctyl Salicylate, C18-21 Alkane, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Citric Acid, Coco-Glucoside, Dicaprylyl Carbonate, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearoyl Stearate, Isononyl Isononanoate, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyester-8, Polyhydroxystearic Acid, Propanediol, Silica, Sodium Gluconate, Sodium Stearoyl Glutamate, Squalene, Tocopherol, Water

🎯 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 ↗
← 73088-0106-12 · TUBBY 73088-0108-01 · Tubby →
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.