Home › NDC Lookup › Ingredients › Titanium Dioxide Zinc Oxide › 79753-0029-71
COOLA BARE REPUBLIC MINERAL SPORT SPF50 Titanium Dioxide, Zinc Oxide 78 mg/mL; 29 mg/mL Lotion, 148 mL — NDC 79753-0029-71 package photo

COOLA BARE REPUBLIC MINERAL SPORT SPF50 Titanium Dioxide, Zinc Oxide 78 mg/mL; 29 mg/mL Lotion, 148 mL

by COOLA, LLC · 148 mL in 1 BOTTLE (79753-029-71)
NDC 79753-0029-71
🏷️ FDA NDC (as labeled) 79753-029-71 billing pads the product segment with a zero
This package
Contains148 mL Pack sizes2 compare ↓
Also comes in: 946 ml 79753-0029-72
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 →

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) 79753-029-71
Product NDC 79753-029
11-digit billing NDC 79753002971
UNII SOI2LOH54Z, 15FIX9V2JP
Application # M020
SPL Set ID bbf15e58-c160-d599-e053-2a95a90a0696
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-11-01
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 79753-029-71 — 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 → 79753-0029-71. 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

LabelerCOOLA, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code79753
First marketedNov 2018
Product typeHuman Otc Drug
Portfolio31 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?

This is an over-the-counter mineral sunscreen lotion applied to the skin. It contains titanium dioxide and zinc oxide, which are inorganic UV filters that work by sitting on top of the skin to reflect and scatter ultraviolet light. Products with these ingredients are commonly used to help protect exposed skin from the sun's rays.

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 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 7HLS05KP9O
    A natural flavoring compound derived from plants or created synthetically. It's added to medicines to improve taste by providing a creamy, fruity flavor note, making the medicine more pleasant to swallow.
  • UNII I1XGH66S8P
    A naturally-derived liquid compound used as a flavoring agent in medicines. It provides a creamy, coconut-like taste to mask bitter drug flavors and improve how the medication tastes to patients.
  • UNII UHD6M52X0K
    Gamma-octalactone is a natural flavoring compound derived from plants. It's added to medicines to mask unpleasant tastes and improve palatability, particularly in liquid formulations.
  • UNII U04IC2765C
    A clear liquid alcohol derived from phenyl compounds, used as a solvent and preservative in liquid medicines to help dissolve active ingredients and prevent microbial growth.
  • UNII 7QY1MH15BG
    A synthetic organic compound used as a flavoring agent in medicines. It provides a mild, pleasant taste to mask bitter drug flavors and improve patient acceptance of oral formulations.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII AU4CYG9V68
    Allyl heptanoate is a synthetic fragrance compound used as a flavoring agent in medicines. It provides taste and aroma to mask bitter or unpleasant flavors in oral formulations.
  • 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 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 035JKJ76MT
    A silicone-based ingredient that helps oil and water mix together in formulations. It works as an emulsifier to create smooth, stable textures in topical medicines and creams.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • 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 S3KFG6Q5X8
    An organic chemical compound used as a UV filter in topical formulations. It helps protect the medicine or product from degradation caused by sunlight exposure during storage and use.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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 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 TP11QR7B8R
    A natural oil extracted from kukui nuts, used as an emollient and skin-conditioning agent in topical medicines. It helps soften the formulation and improve how the product spreads and absorbs into skin.
  • UNII ZJ5S27D9NX
    A silicone-based substance that combines polymers with lauryl (a fatty compound). It acts as an emulsifier and surfactant to help mix oil and water ingredients and improve how the medicine feels when applied or swallowed.
  • 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 X323T6QO4M
    A synthetic polymer made from citric acid and long-chain alcohols. It acts as a film-former and thickener in topical products, helping create a smooth texture and improve how the medicine spreads on skin.
  • UNII 6J1M3WA0ZK
    A red algae-derived mineral rich in calcium carbonate. Used as a filler and buffer to add bulk to the tablet or capsule and help maintain stable pH levels in the formulation.
  • UNII KE109YAK00
    A chemical compound used as a flavoring agent and fragrance in medicines. It gives products a subtle vanilla or anise-like taste and odor to make them more pleasant to take.
  • UNII 4R4HFI6D95
    Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
  • 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 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 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 08MNR5YE2R
    A wax made in a laboratory to mimic natural beeswax. It's used as a coating, binder, and thickener to give medicines a smooth texture and protect them from moisture.
  • 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 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
  • UNII CHI530446X
    Vanillin is a natural or synthetic aromatic compound that gives vanilla flavor. It's used in medicines as a flavoring agent to mask bitter tastes and improve how the medicine tastes.
  • 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.

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

The official label also statesAlcohol, AleuritesMoluccana (Kukui) Seed Oil, Algae Exract, Allyl Heptoate, Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Gamma Decalactone, Gamma Nonalactone, Gamma Octalactone, Glycerin, Heliotropine, Isohecxadecane, Lauryl PEG-8 Dimethicone, Octyldodecyl Citrate Crosspolymer, PEG-8, Phenylpropenol, Raspberry Ketone, Silica, Sodium Chloride, Sodium Citrate, Tocopheryl Acetate, Triethoxycaprylylsilane, Triethyl Citrate, Vanillin, Vegan Beeswax, 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 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: 946 ml
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
Coola Bare Republic Mineral Sport Spf50 78 mg/mL; 29 mg/mLthis 79753-0029-71 COOLA, 148 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

🏛️
2018
On the market since
Nov 2018
📍
2026
Currently FDA-listed
8 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 COOLA BARE REPUBLIC MINERAL SPORT SPF50 (this brand).

Top reported reactions

Application Site Acne1
Application Site Hypersensitivity1
Application Site Vesicles1

Reporter sex

1 reports
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
79753-0029-71 You're viewing this 148 mL in 1 BOTTLE (79753-029-71) 2018-11-01 Active
79753-0029-72 946 mL in 1 BOTTLE (79753-029-72) 2018-11-01 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 79753-0029-71?
NDC 79753-0029-71 contains 148 mL — 148 ml in 1 bottle.
What is the difference between NDC 79753-0029-71 and NDC 79753-0029-72?
Both are COOLA BARE REPUBLIC MINERAL SPORT SPF50 Titanium Dioxide, Zinc Oxide 78 mg/mL; 29 mg/mL Lotion — the drug itself is identical. NDC 79753-0029-71 is the 148 mL package, while NDC 79753-0029-72 is the 946 ml package.
What NDC number is used to bill for this package of COOLA BARE REPUBLIC MINERAL SPORT SPF50 Titanium Dioxide, Zinc Oxide 78 mg/mL; 29 mg/mL Lotion?
Bill NDC 79753-0029-71 — the 11-digit billing format is 79753002971. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 79753-029-71, 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: 79753-0029-71, written without dashes as 79753002971. 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 79753-0029-71, the first segment (79753) is the labeler code FDA assigned to COOLA, LLC; the middle segment (0029) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (71) 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 COOLA, LLC. 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 1 other package presentation of this same product, including 946 ml (79753-0029-72). 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?
COOLA, LLC 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 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 93 words ▾

Directions apply liberally 15 minutes before sun exposure reapply: -after 80 minutes of swimming or sweating -immediately after towel drying -at least every 2 hours children under 6 months of age: 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 a.m.-2 p.m. -wear long-sleeved shirts, pants, hats, and sunglasses

⚠️ Warnings 5 words ▾

Warnings For external use only

📦 Storage and Handling 20 words ▾

Other information protect this product from excessive heat and direct sun may stain or damage some fabrics, materials or surfaces

🧪 Active Ingredient 8 words ▾

Active ingredients Titanium Dioxide 2.9%, Zinc Oxide 7.8

🧪 Inactive Ingredients 69 words ▾

Inactive Ingredients Alcohol, AleuritesMoluccana (Kukui) Seed Oil, Algae Exract, Allyl Heptoate, Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Gamma Decalactone, Gamma Nonalactone, Gamma Octalactone, Glycerin, Heliotropine, Isohecxadecane, Lauryl PEG-8 Dimethicone, Octyldodecyl Citrate Crosspolymer, PEG-8, Phenylpropenol, Raspberry Ketone, Silica, Sodium Chloride, Sodium Citrate, Tocopheryl Acetate, Triethoxycaprylylsilane, Triethyl Citrate, Vanillin, Vegan Beeswax, 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 ↗
← 79753-0026-01 · COOLA 79753-0032-01 · COOLA →
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.