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COOLA Refreshing Water Mist SPF 18 Avobenzone, Homosalate, Octisalate, Octocrylene 2 g/100mL; 10 g/100mL; 5 g/100mL; 5.5 g/100mL Spray — NDC 54111-0148-50 package photo

COOLA Refreshing Water Mist SPF 18 Avobenzone, Homosalate, Octisalate, Octocrylene 2 g/100mL; 10 g/100mL; 5 g/100mL; 5.5 g/100mL Spray

by Bentley Laboratories, LLC · 1 BOTTLE in 1 CARTON (54111-148-50) / 50 mL in 1 BOTTLE
NDC 54111-0148-50
🏷️ FDA NDC (as labeled) 54111-148-50 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

🆔 Identity & classification

FDA NDC (as labeled) 54111-148-50
Product NDC 54111-148
11-digit billing NDC 54111014850
UNII G63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM
Application # M020
SPL Set ID 658bf3fe-2246-40b6-8cb1-969bfdaffd1b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-07-30
Route TOPICAL
Dosage form SPRAY
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 54111-148-50 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 54111-0148-50. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerBentley Laboratories, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code54111
First marketedJul 2020
Product typeHuman Otc Drug
Portfolio35 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?

COOLA Refreshing Water Mist SPF 18 is an over-the-counter sunscreen spray marketed under FDA monograph rules for topical use. It contains four UV-filtering agents (avobenzone, homosalate, octisalate, and octocrylene) that are typically used to absorb and scatter ultraviolet light from the sun. This product is designed to be sprayed onto exposed skin as part of routine sun protection. The SPF 18 rating indicates the level of protection these filters are intended to provide against UVB 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 CNA0S5T234
    A naturally derived organic compound used as a flavoring agent in medicines. It provides a creamy, fruity taste to mask bitter or unpleasant flavors in oral medications.
  • 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 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 0ECG3V79ZJ
    Benzyl acetate is a clear liquid chemical used as a solvent and fragrance component in medicines. It helps dissolve other ingredients and may contribute to the product's smell or taste.
  • 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 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 D9108TZ9KG
    Cocoa is a natural powder made from roasted cacao beans. It's used as a flavoring and coloring agent to make medicines taste better and appear brown.
  • UNII 267F5Y81NT
    Coconut water is a natural liquid from inside coconut fruits. It's used in medicines as a vehicle or solvent to help dissolve and deliver active ingredients, and sometimes as a flavor or sweetening agent.
  • UNII JXN40O9Y9B
    A synthetic antimicrobial agent used as a preservative in liquid medicines and topical products. It helps prevent bacterial and fungal growth to maintain product stability and safety during storage.
  • UNII UFD2LZ005D
    Ethyl butyrate is a synthetic flavoring compound that smells fruity and buttery. It's added to medicines to improve taste and mask unpleasant flavors, making them easier to take.
  • 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 6OG06384ID
    A plant extract from jasmine leaves used as a flavoring agent and fragrance ingredient to improve the taste and aroma of medicines.
  • UNII 4739QA5686
    A natural oil extracted from juniper wood, used as a fragrance and flavoring agent in medicines to improve taste and aroma.
  • 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 6618K1VJ9T
    A liquid ester compound used as a solvent and preservative in medications. It helps dissolve active ingredients and prevents microbial growth in liquid formulations.
  • UNII N8F53B3R4R
    A synthetic humectant and solvent derived from propane. It draws and holds moisture in the formulation, helping keep the medicine stable and improving texture or flow in liquid and semi-solid products.
  • UNII QR6IP857S6
    Nerolidol is a fragrant plant-derived oil used as a flavor and fragrance ingredient in medicines. It helps mask bitter or unpleasant tastes and provide a more pleasant sensory experience.
  • UNII 9PA5V6656V
    A naturally derived aromatic compound with a sweet, licorice-like odor. Used as a flavoring agent in medicines to mask bitter or unpleasant tastes and improve palatability.
  • UNII 88496G1ERL
    Sodium phytate is a plant-derived salt used in medications as a chelating agent and preservative. It helps stabilize formulations and may improve how the body absorbs certain minerals in the medicine.
  • 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 3N8LGV97HR
    A synthetic polymer used as a film-former and suspending agent. It helps create a protective coating on tablets or capsules and keeps particles evenly distributed in liquid 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 T8L6O1KSB4
    Schinus molle fruiting top is a plant-derived ingredient, commonly known as pink peppercorn. It's used in medicines as a flavoring agent to improve taste.
  • UNII A3LZF0L939
    Tridecane is a clear, colorless liquid hydrocarbon derived from petroleum. It acts as a solvent and lubricant in medicines, helping distribute active ingredients evenly and reducing friction 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 JV0QT00NUE
    Undecane is a clear liquid hydrocarbon derived from petroleum. It functions as a solvent and processing aid in medicines, helping dissolve or suspend active ingredients and improve how the drug is manufactured and delivered.
  • 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.

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

The official label also statesInactive Ingredients Aloe Barbadensis Leaf Extract (ORGANIC), Undecane, Tridecane, Water, Cocos Nucifera (Coconut) Water (ORGANIC), Sodium Hyaluronate, Jasminum Sambac (Jasmine) Leaf Cell Extract, Theobroma Cacao (Cocoa) Seed Extract, Schinus Molle Extract, Heliotropine*, Juniperus Mexicana*, Propanediol, Butylene Glycol, Methlypropanediol, Caprylic/Capric Triglyceride, Caprylyl Glycol, Polyquaternium-80, Sodium Phytate, Didecyldimonium Chloride, Anisaldehyde*, Benzyl acetate*, Delta-Decalactone*, Gamma-Nonalactone*, Gamma Octalactone*, Methyl benzoate*, Nerolidol*, Ethyl Butyrate*, Triethyl citrate*, Vanillin * Plant-derived scent constituent.

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
COOLA Refreshing Water Mist SPF 18 2 g/100mL; 10 g/100mL; 5 g/100mL; 5.5 g/100mLthis 54111-0148-50 Bentley 1 bottle — — 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
Jul 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.

🔬 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 Refreshing Water Mist SPF 18 (this brand).

Top reported reactions

Acute Myeloid Leukaemia2
Exposure To Toxic Agent2
Product Contamination Chemical2
Rash2
Anaphylactic Reaction1
Application Site Erythema1
Application Site Exfoliation1

Age at onset

Adolescent2
Adult1

Reporter sex

6 reports
Male · 20%
Female · 80%

Serious outcomes

Hospitalization2
Life-threatening1
Death1
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 2 1
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
54111-0148-50 You're viewing this 1 BOTTLE in 1 CARTON (54111-148-50) / 50 mL in 1 BOTTLE 2020-07-30 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 54111-148-50, 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: 54111-0148-50, written without dashes as 54111014850. 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 54111-0148-50, the first segment (54111) is the labeler code FDA assigned to Bentley Laboratories, LLC; the middle segment (0148) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) 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 Bentley Laboratories, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bentley Laboratories, 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 32 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 99 words ▾

Directions • shake well • apply liberally 15 minutes before sun exposure • reapply: •after 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 aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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 • children under 6 months: Ask a doctor

⚠️ Warnings 35 words ▾

Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask doctor if skin rash occurs

🧪 Active Ingredient 14 words ▾

Drug Facts Active Ingredients Avobenzone 2.0%. Homosalate 10.0% Octisalate 5.0%, Octocrylene 5.5% Purpose Sunscreen

🧪 Inactive Ingredients 66 words ▾

Inactive Ingredients Aloe Barbadensis Leaf Extract (ORGANIC), Undecane, Tridecane, Water, Cocos Nucifera (Coconut) Water (ORGANIC), Sodium Hyaluronate, Jasminum Sambac (Jasmine) Leaf Cell Extract, Theobroma Cacao (Cocoa) Seed Extract, Schinus Molle Extract, Heliotropine*, Juniperus Mexicana*, Propanediol, Butylene Glycol, Methlypropanediol, Caprylic/Capric Triglyceride, Caprylyl Glycol, Polyquaternium-80, Sodium Phytate, Didecyldimonium Chloride, Anisaldehyde*, Benzyl acetate*, Delta-Decalactone*, Gamma-Nonalactone*, Gamma Octalactone*, Methyl benzoate*, Nerolidol*, Ethyl Butyrate*, Triethyl citrate*, Vanillin * Plant-derived scent constituent.

🎯 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 ↗
← 54111-0146-50 · Bentley 54111-0159-50 · Bentley →
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.