COOLA CLASSIC SUNSCREEN FRAGRANCE FREE Avobenzone, Homosalate, Octisalate, Octocrylene 100 mg/mL; 30 mg/mL; 80 mg/mL; 45 mg/mL Lotion, 946 mL — NDC 79753-0045-72 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

COOLA CLASSIC SUNSCREEN FRAGRANCE FREE Avobenzone, Homosalate, Octisalate, Octocrylene 100 mg/mL; 30 mg/mL; 80 mg/mL; 45 mg/mL Lotion, 946 mL — NDC 79753-045-72 (Billing 79753-0045-72)

by COOLA, LLC · 946 mL in 1 BOTTLE

This is a package of 946 mL of COOLA CLASSIC SUNSCREEN FRAGRANCE FREE Avobenzone, Homosalate, Octisalate, Octocrylene 100 mg/mL; 30 mg/mL; 80 mg/mL; 45 mg/mL Lotion from COOLA, LLC, marketed since Jan 2018 and currently FDA-listed. It is this product's only package size.

NDC 79753-0045-72
🏷️ FDA NDC (as labeled) 79753-045-72 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 →

NDC database record

One package, one record: these facts belong to NDC 79753-045-72 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
79753 labeler · 045 product · 72 package
Package marketed since
Jan 1, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7975304572 0
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 79753-045-72
Product NDC 79753-045
11-digit billing NDC 79753004572
UNII V06SV4M95S, G63QQF2NOX, 5A68WGF6WM, 4X49Y0596W
Application # M020
SPL Set ID cfc21b1a-4a26-1573-e053-2995a90a2d50
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-01-01
Route TOPICAL
Dosage form LOTION
Substance HOMOSALATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE
Why two NDCs? The FDA registers this code as 79753-045-72 — 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 → 79753-0045-72. 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?

Coola Classic Sunscreen Fragrance Free is a topical lotion containing four active ingredients that function as ultraviolet (UV) filters. Avobenzone, homosalate, octisalate, and octocrylene are commonly used together in sunscreen products to help absorb and scatter UV radiation from the sun. This is an over-the-counter monograph product, meaning it is marketed under FDA's established rules for sunscreen ingredients rather than as an individually reviewed drug application.

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
79753-0045-72 You're viewing this Main listing 946 mL in 1 BOTTLE 2018-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Coola Classic Sunscreen Fragrance Free 100 mg/mL; 30 mg/mL; 80 mg/mL; 45 mg/mLthis 79753-0045-72 COOLA, 946 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
Jan 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.

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 7QWA1RIO01
    A synthetic form of vitamin E used as an antioxidant in medicines. It prevents oils and fats in the formulation from breaking down, helping the drug remain stable and effective during storage.
  • 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 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 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 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII 2EH13UN8D3
    A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
  • UNII 4J4P6L645M
    Carboxymethylcellulose sodium is a plant-derived thickener made from cellulose. It acts as a binder to hold tablet ingredients together and a viscosity agent to control how thick or thin the medicine flows.
  • 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 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 9G1OE216XY
    Docosanol is a waxy, fatty alcohol derived from plant sources. It acts as an emollient and thickener in topical medicines, helping to soften the skin and improve product texture and stability.
  • 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 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 258491E1RZ
    A waxy substance made from glycerin and stearic acid, commonly used as an emulsifier to help blend oil and water ingredients together in medicines. It also helps thicken and stabilize the product's texture.
  • UNII 178A96NLP2
    Lauryl alcohol is a fatty alcohol derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping blend oil and water-based ingredients and giving the product a smooth, creamy texture.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII 84XB4DV00W
    Linseed oil is a plant-based oil extracted from flax seeds. It's used in medicines as an emollient and lubricant to improve texture and help with ingredient mixing in formulations.
  • UNII 930626MWDL
    A plant extract from goji berries used as a natural coloring agent and flavor enhancer in medicines. It may add color and taste while serving as a source of beneficial plant compounds in the formulation.
  • 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 JY15982UBB
    A plant extract from bee balm leaves used as a flavoring agent and fragrance component in medicines. It adds taste and aroma to oral products.
  • UNII V42034O9PU
    A fatty alcohol derived from coconut or palm oil. It serves as an emulsifier and thickener to help blend oil and water in creams or lotions, and improves the product's texture and consistency.
  • UNII 2V16EO95H1
    Palmitic acid is a saturated fatty acid derived from plant and animal sources. It serves as an emulsifier and lubricant in medicines, helping ingredients mix smoothly and preventing sticking during manufacturing.
  • 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 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 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 9S8867952A
    A plant-derived oil from raspberry seeds used as an emollient and skin-conditioning agent in topical formulations. It helps soften the product texture and improve skin feel.
  • UNII 836SJG51DR
    Sodium ascorbyl phosphate is a derivative of vitamin C that acts as an antioxidant and preservative in medications. It helps protect the drug's active ingredients from degradation caused by air and light exposure.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 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 statesAlkyl Heptoate, Behenyl Alcohol, Butylated PVP, Butylene Glycol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Cellulose Gum, Cetyl Alcohol, Citrus Aurantium Bergamia (Bergamot) Leaf Extract, Disodium EDTA, Ethylhexylglycerin, Gamma-Decalactone, Gamma-Nonalactone, Glycerin, Glyceryl Stearate, Heliotropine, Lauryl Alcohol, Lecithin, Linum Usitatissimum (Linseed) Seed Oil, Lycium Barbarum Fruit Extract, Microcrystalline Cellulose, Myristyl Alcohol, Palmitic Acid, Phenoxyethanol, Propylene Glycol, Raspberry Ketone, Rubus Idaeus (Raspberry) Seed Extract, Sodium Ascorbyl Phosphate, Stearic Acid, Tocopherol, Triethyl Citrate, Vanillin, Water (Aqua)

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

LabelerCOOLA, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code79753
First marketedJan 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.

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 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 10 words ▾

Active ingredients Avobenzone 3.0% Homosalate 10.0% Octisalate 4.5% Octocrylene 8.0%

🧪 Inactive Ingredients 72 words ▾

Inactive Ingredients Alkyl Heptoate, Behenyl Alcohol, Butylated PVP, Butylene Glycol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Cellulose Gum, Cetyl Alcohol, Citrus Aurantium Bergamia (Bergamot) Leaf Extract, Disodium EDTA, Ethylhexylglycerin, Gamma-Decalactone, Gamma-Nonalactone, Glycerin, Glyceryl Stearate, Heliotropine, Lauryl Alcohol, Lecithin, Linum Usitatissimum (Linseed) Seed Oil, Lycium Barbarum Fruit Extract, Microcrystalline Cellulose, Myristyl Alcohol, Palmitic Acid, Phenoxyethanol, Propylene Glycol, Raspberry Ketone, Rubus Idaeus (Raspberry) Seed Extract, Sodium Ascorbyl Phosphate, Stearic Acid, Tocopherol, Triethyl Citrate, Vanillin, Water (Aqua)

🎯 Purpose 2 words ▾

Purpose 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 20 words ▾

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

📄 Package Label / Principal Display Panel 4 words ▾

Label CA61410 CA00770 CA00761

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 COOLA, LLC. Listing status can change — the directory data on this page refreshes weekly.
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.
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.