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COOLA Zinc Oxide BodyLotion SPF 50 Fragrance-Free 12.61 g/100mL Lotion, 41 mL — NDC 79753-0108-02 package photo

COOLA Zinc Oxide BodyLotion SPF 50 Fragrance-Free 12.61 g/100mL Lotion, 41 mL

by COOLA LLC · 41 mL in 1 TUBE (79753-108-02)
NDC 79753-0108-02
🏷️ FDA NDC (as labeled) 79753-108-02 billing pads the product segment with a zero
This package
Contains41 mL Pack sizes2 compare ↓
Also comes in: 100 ml 79753-0108-01
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 79753-108-02
Product NDC 79753-108
11-digit billing NDC 79753010802
UNII SOI2LOH54Z
Application # M020
SPL Set ID 4cad89a5-325c-b3c2-e063-6294a90ac225
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-01
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 79753-108-02 — 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 → 79753-0108-02. 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 marketedMar 2026
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 a fragrance-free body lotion containing zinc oxide, an inorganic mineral sunscreen active ingredient. Zinc oxide is commonly used in sunscreen products to help protect skin from ultraviolet (UV) radiation. Applied topically to the skin, it functions as a broad-spectrum UV filter with an SPF rating of 50. This product is an over-the-counter monograph drug, meaning it is marketed under the FDA's established rules for sunscreen ingredients and formulations.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Zinc oxide (OTC drug) (3 interactions) — ranked by severity →
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 RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • UNII TY3J98ZR7R
    A synthetic polymer that acts as a film-former and texture enhancer in topical formulations. It helps create a smooth, long-wearing coating on skin and improves how the product spreads and adheres.
  • 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 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 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 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 65UEH262IS
    Safflower oil is a plant-based oil extracted from safflower seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and sometimes as an emollient to improve texture.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII ZF3R3PTA9C
    A fermented liquid derived from baker's yeast and Japanese cedar leaf extract. It functions as a humectant to retain moisture and may serve as a conditioning or skin-softening agent in the formulation.
  • UNII 057N7SS26Y
    A clear, oily liquid derived from succinic acid and alcohol chains. It functions as a plasticizer and solvent in formulations, helping soften coatings and improve flexibility of film-coated tablets.
  • UNII 5B8915UELW
    A plant-derived compound used as an antioxidant in medicines. It helps prevent spoilage and degradation of active ingredients during storage by protecting them from oxidative damage.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII 412ZHA4T4Y
    A plant-derived oil extracted from meadowfoam seeds. It acts as an emollient and skin-conditioning agent, helping soften and smooth the product texture while improving how it spreads on skin.
  • UNII 48H19MS04L
    A natural oil derived from the fruit of the Mauritia flexuosa palm tree. It serves as an emollient and skin-conditioning agent in topical formulations, helping soften and smooth the product's texture.
  • 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 1XGW49AK2J
    A natural oil derived from prickly pear cactus seeds. It's used in medicines as an emollient to soften and smooth the product's texture, and sometimes as a skin-conditioning agent in topical formulations.
  • UNII R60QEP13IC
    Rice bran is a natural powder made from the outer layer of rice grains. It's used in medicines as a filler and flow agent to add bulk and help the product mix and flow smoothly during manufacturing.
  • UNII 4T2L7QI313
    A waxy, plant-derived thickener made from glycerol and behenic acid. It's used as an emulsifier and stabilizer to help blend oil and water-based ingredients together and maintain texture in creams and lotions.
  • UNII ETY9Q81E2T
    A synthetic emulsifier made from glycerin and stearic acid. It helps blend oil and water-based ingredients together so the medicine mixes evenly and stays stable.
  • 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 QX10HYY4QV
    Sesame oil is a plant-derived oil from sesame seeds. It's used in medicines as a solvent or carrier to dissolve or suspend active ingredients, helping them mix evenly throughout the formulation.
  • UNII 5EHL50I4MY
    A sodium salt compound used as a chelating agent in medicines. It binds to metals and minerals to improve stability, prevent discoloration, and help the medication stay effective longer.
  • 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 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesAloe Barbadensis Leaf Juice (ORGANIC), Caprylic/Capric Triglyceride (ORGANIC), Butyloctyl Salicylate, Glycerin (ORGANIC), Polyglyceryl-6 Stearate, Oryza Sativa (Rice) Bran Oil (ORGANIC), Bis-Octyldodecyl Dimer Dilinoleate/Propanediol Copolymer, Microcrystalline Cellulose, Sesamum Indicum (Sesame) Seed Oil (ORGANIC), Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Mauritia Flexuosa Fruit Oil (ORGANIC), Opuntia Ficus-Indica Seed Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Saccharomyces Ferment Filtrate (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, 1,2-Hexanediol, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cetearyl Alcohol, Diheptyl Succinate, Ethyl Ferulate, Glyceryl Stearates, Hydroxyacetophenone, Polyglyceryl-6 Behenate, Tetrasodium Glutamate Diacetate, Triethoxycaprylylsilane, Tropolone, Water (Aqua), Xanthan Gum

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: 100 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 Zinc Oxide BodyLotion SPF 50 Fragrance-Free 12.61 g/100mLthis 79753-0108-02 COOLA 41 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

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 Zinc Oxide BodyLotion SPF 50 Fragrance-Free (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Reporter sex

1,941 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization988
Death204
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 196 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
79753-0108-01 100 mL in 1 TUBE (79753-108-01) 2026-03-01 Active
79753-0108-02 You're viewing this 41 mL in 1 TUBE (79753-108-02) 2026-03-01 Active

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

Pack size FAQ

What quantity is in NDC 79753-0108-02?
NDC 79753-0108-02 contains 41 mL — 41 ml in 1 tube.
What is the difference between NDC 79753-0108-02 and NDC 79753-0108-01?
Both are COOLA Zinc Oxide BodyLotion SPF 50 Fragrance-Free 12.61 g/100mL Lotion — the drug itself is identical. NDC 79753-0108-02 is the 41 mL package, while NDC 79753-0108-01 is the 100 ml package.
What NDC number is used to bill for this package of COOLA Zinc Oxide BodyLotion SPF 50 Fragrance-Free 12.61 g/100mL Lotion?
Bill NDC 79753-0108-02 — the 11-digit billing format is 79753010802. 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 79753-108-02, 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: 79753-0108-02, written without dashes as 79753010802. 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 79753-0108-02, the first segment (79753) is the labeler code FDA assigned to COOLA LLC; the middle segment (0108) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 100 ml (79753-0108-01). 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 🧪 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 92 words ▾

Directions Shake well. Apply liberally 15 minutes before sun exposure Reapply: After 80 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.

To decrease 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 56 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 Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Actice Ingredient Zinc Oxide 12.61%

🧪 Inactive Ingredients 97 words ▾

Inactive Ingredients Aloe Barbadensis Leaf Juice (ORGANIC), Caprylic/Capric Triglyceride (ORGANIC), Butyloctyl Salicylate, Glycerin (ORGANIC), Polyglyceryl-6 Stearate, Oryza Sativa (Rice) Bran Oil (ORGANIC), Bis-Octyldodecyl Dimer Dilinoleate/Propanediol Copolymer, Microcrystalline Cellulose, Sesamum Indicum (Sesame) Seed Oil (ORGANIC), Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Mauritia Flexuosa Fruit Oil (ORGANIC), Opuntia Ficus-Indica Seed Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Saccharomyces Ferment Filtrate (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, 1,2-Hexanediol, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cetearyl Alcohol, Diheptyl Succinate, Ethyl Ferulate, Glyceryl Stearates, Hydroxyacetophenone, Polyglyceryl-6 Behenate, Tetrasodium Glutamate Diacetate, Triethoxycaprylylsilane, Tropolone, Water (Aqua), Xanthan Gum

🎯 Purpose 4 words ▾

Purpose Zinc Oxide 12.61%...............Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 79753-0107-01 · COOLA 79794-0114-01 · Zhejiang →
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.