Refreshing Water Hydration Stick SPF 50 AVOBENZONE OCTISALATE HOMOSALATE OCTOCRYLENE 2.5 g/100g; 2.15 g/100g; 3.5 g/100g; 5 g/100g Stick — NDC 79753-0035-01 package photo

Refreshing Water Hydration Stick SPF 50 AVOBENZONE OCTISALATE HOMOSALATE OCTOCRYLENE 2.5 g/100g; 2.15 g/100g; 3.5 g/100g; 5 g/100g Stick

by COOLA LLC · 1 CANISTER in 1 CARTON (79753-035-01) / 22 g in 1 CANISTER
NDC 79753-0035-01
🏷️ FDA NDC (as labeled) 79753-035-01 billing pads the product segment with a zero
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 →

🆔 Identity & classification

FDA NDC (as labeled) 79753-035-01
Product NDC 79753-035
11-digit billing NDC 79753003501
UNII G63QQF2NOX, 4X49Y0596W, V06SV4M95S, 5A68WGF6WM
Application # M020
SPL Set ID 6da037f8-bedb-467a-b534-e44752120f2c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-01-16
Route TOPICAL
Dosage form STICK
Substance AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 79753-035-01 — 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 → 79753-0035-01. 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 marketedJan 2023
Product typeHuman Otc Drug
Portfolio25 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 sunscreen stick marketed under FDA's monograph rule for topical sunscreen products. It contains four active ingredients that function as ultraviolet (UV) filters: avobenzone, homosalate, octisalate, and octocrylene. These chemicals are commonly combined in sunscreen formulations to absorb UV radiation and are typically used to help protect skin from sun exposure. The product is applied directly to the skin in stick form and carries an SPF 50 rating.

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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 575DY8C1ER
    Aloe vera flower is a natural plant extract used in medicines as a skin-soothing agent and emollient. It helps soften and moisturize formulations, particularly in topical products like creams and lotions.
  • 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 3TE8A92UPM
    Azadirachta indica flower is a botanical extract from the neem plant. It may be used in formulations for its traditional preservative or antioxidant properties to help maintain product stability.
  • UNII HKY915780T
    A plant extract from the neem tree, used as a natural flavoring agent and preservative in medicines. It may help maintain product stability and add bitter taste characteristics.
  • 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 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 R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII 9S60Q72309
    A plant-derived ingredient made from safflower seed components. It acts as an emulsifier and carrier to help distribute oils and active ingredients evenly throughout the medicine.
  • UNII VLJ6WOT3K5
    A plant extract from the Coccinia indica fruit, used in herbal and traditional formulations. It may serve as a natural flavoring agent, colorant, or active botanical component depending on the product's intended use.
  • 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 4004498D06
    A red algae extract used as a natural colorant and pH buffer in medicines. It provides reddish tones to tablets and capsules while helping maintain stable acidity levels in the formulation.
  • UNII W5K7RAS4VK
    A purple vegetable extract used as a natural colorant in some medicines. It provides color to tablets or capsules without affecting how the drug works.
  • 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 SCJ765569P
    Holy basil leaf is a plant-derived ingredient used in some formulations as a flavoring agent or botanical additive. It may contribute taste and aroma to the medicine.
  • UNII S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • 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 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII 7SAB275FP2
    A plant extract made from basil flowers and leaves. It's used in medicines as a flavoring agent and may help preserve the product by providing natural antimicrobial properties.
  • UNII TL8V5BW2HC
    Polyglyceryl-10 caprate is a surfactant derived from glycerin and coconut oil. It helps oils and water mix together in liquid formulas and improves how the medicine spreads on or absorbs into the skin.
  • UNII YS396CQX5C
    A plant-derived emulsifier made from glycerin and caprylic acid (a natural fatty acid). It helps mix water and oil-based ingredients together and keeps the medicine's texture stable.
  • 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 QU7E2XA9TG
    Sodium stearate is a salt derived from stearic acid, a natural fatty substance. It acts as a lubricant and binder in tablets and capsules, helping the medicine hold together and flow smoothly during manufacturing.
  • UNII MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • UNII 7L6DL16P1T
    Tropolone is a naturally occurring organic compound used in medicines as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the product.
  • UNII 856YO1Z64F
    Turmeric is a natural spice derived from the turmeric plant root. It serves as a colorant in medicines, giving products a yellow or golden appearance, and may also provide mild flavoring.
  • UNII KFR5QEN0N9
    A synthetic plastic polymer that helps form a protective film coating on the medicine. It's used as a binder and film-former to hold the tablet or capsule together and control how quickly the drug dissolves.
  • 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.

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

The official label also statesInactive Ingredients Aloe Barbadensis Leaf Juice (ORGANIC), Glycerin (ORGANIC), Sodium Stearate, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Polyglyceryl-10 Caprylate/Caprate, Butyloctyl Salicylate, Copernicia Cerifera (Carnauba) Wax (ORGANIC), Sorbitan Olivate, VP/Hexadecene Copolymer, Cocos Nucifera (Coconut) Fruit Water (ORGANIC), Jasminum Sambac (Jasmine) Leaf Cell Extract, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Coralline Officinalis Extract, Solanum Melongena (Eggplant) Fruit Extract, Theobroma Cacao (Cocoa) Seed Extract, Aloe Barbadensis Flower Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Hyaluronic Acid, Coccinia Indica Fruit Extract, Curcuma Longa (Turmeric) Root Extract, Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum Sanctum Leaf Extract, Schinus Molle Extract, Propanediol, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Water, Tropolone, Fragrance (Natural)

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 eachPer 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
Refreshing Water Hydration Stick SPF 50 2.5 g/100g; 2.15 g/100g; 3.5 g/100g; 5 g/100gthis 79753-0035-01 COOLA 1 canister — — 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

🏛️
2023
On the market since
Jan 2023
📍
2026
Currently FDA-listed
3 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
79753-0035-01 You're viewing this 1 CANISTER in 1 CARTON (79753-035-01) / 22 g in 1 CANISTER 2023-01-16 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 79753-035-01, 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: 79753-0035-01, written without dashes as 79753003501. 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 79753-0035-01, the first segment (79753) is the labeler code FDA assigned to COOLA LLC; the middle segment (0035) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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.
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 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 95 words ▾

Directions ●apply liberally 15 minutes before sun exposure. ● reapply: ●after swimming or sweating ● immediately afte 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 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-sleeve 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 2.5%, Homosalate 3.5%, Octisalate 2.15%, Octocrylene 5.0% Purpose Suncreen

🧪 Inactive Ingredients 104 words ▾

Inactive Ingredients Aloe Barbadensis Leaf Juice (ORGANIC), Glycerin (ORGANIC), Sodium Stearate, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Polyglyceryl-10 Caprylate/Caprate, Butyloctyl Salicylate, Copernicia Cerifera (Carnauba) Wax (ORGANIC), Sorbitan Olivate, VP/Hexadecene Copolymer, Cocos Nucifera (Coconut) Fruit Water (ORGANIC), Jasminum Sambac (Jasmine) Leaf Cell Extract, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Coralline Officinalis Extract, Solanum Melongena (Eggplant) Fruit Extract, Theobroma Cacao (Cocoa) Seed Extract, Aloe Barbadensis Flower Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Hyaluronic Acid, Coccinia Indica Fruit Extract, Curcuma Longa (Turmeric) Root Extract, Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum Sanctum Leaf Extract, Schinus Molle Extract, Propanediol, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Water, Tropolone, Fragrance (Natural)

🎯 Purpose 2 words ▾

Purpose Suncreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.