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COOLA Mineral Sun Silk Creme Sunscreen SPF 30 ZINC OXIDE 158 mg/mL Lotion — NDC 79753-070-01 (Billing 79753-0070-01)

by COOLA LLC · 1 BOTTLE in 1 BOX / 44 mL in 1 BOTTLE

This is a package of COOLA Mineral Sun Silk Creme Sunscreen SPF 30 ZINC OXIDE 158 mg/mL Lotion from COOLA LLC, marketed since Feb 2023 and currently FDA-listed. It is this product's only package size.

NDC 79753-0070-01
🏷️ FDA NDC (as labeled) 79753-070-01 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 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

NDC database record

One package, one record: these facts belong to NDC 79753-070-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
79753 labeler · 070 product · 01 package
Package marketed since
Feb 1, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7975307001 2
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 79753-070-01
Product NDC 79753-070
11-digit billing NDC 79753007001
UNII SOI2LOH54Z
Application # M020
SPL Set ID bb9dd9a9-ec01-4e94-9172-3a72e68a417a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-02-01
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 79753-070-01 — 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 → 79753-0070-01. 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.

Clinical

🧪 What is this product?

This is a mineral sunscreen lotion applied to the skin, marketed as an over-the-counter product under FDA monograph rules. The active ingredient is zinc oxide, a mineral compound that functions as a physical (or barrier) sunscreen by reflecting and scattering ultraviolet rays away from the skin. Products of this type are typically used to help protect exposed skin from sun damage during outdoor activities. The lotion formulation delivers the sunscreen in a smooth, spreadable base intended for topical application.

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.

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
79753-0070-01 You're viewing this Main listing 1 BOTTLE in 1 BOX / 44 mL in 1 BOTTLE 2023-02-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
COOLA Mineral Sun Silk Creme Sunscreen SPF 30 158 mg/mLthis 79753-0070-01 COOLA 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

🏛️
2023
On the market since
Feb 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.

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 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 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 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 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 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 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • UNII WH8T92A065
    A fatty acid derivative made by combining stearic acid with glycerin and citric acid. It acts as an emulsifier to help mix oil and water-based ingredients, and also serves as a thickener in the medicine formulation.
  • UNII 86FQE96TZ4
    A synthetic polymer, this ingredient acts as a thickener and suspending agent in liquid formulations. It helps maintain uniform consistency and keeps particles evenly distributed throughout the medicine.
  • UNII 2S686I937F
    Jasminum sambac flower is a natural plant extract from jasmine flowers. It's used in medicines as a flavoring and fragrance agent to improve taste and smell.
  • 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 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 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII MVJ3AD73GG
    A synthetic liquid derived from coconut oil and polyethylene glycol, used as an emulsifier and solubilizer to help mix water and oil-based ingredients and improve how the medicine dissolves and spreads throughout the formulation.
  • UNII YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • UNII 5XB3A63Y52
    A synthetic rubber polymer used as a glidant and lubricant in tablet and capsule formulations. It reduces friction between particles and equipment surfaces, helping medicines flow smoothly during manufacturing and preventing sticking.
  • 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 01S2G2C1E4
    Sorbitan isostearate is an emulsifier derived from sorbitol and isostearic acid. It helps mix oil and water-based ingredients together and keeps them blended throughout the medicine's shelf life.
  • 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.

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

The official label also statesInactive ingredients Water, Caprylic/Capric Triglyceride, Dimethicone, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Juice Powder, Jasminum Sambac (Jasmine) Leaf Cell Extract, Theobroma Cacao (Cocoa) Seed Extract, Schinus Molle Extract, Niacinamide, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Propanediol, Butylene Glycol, Polyisobutene, Methylpropanediol, Cetearyl Alcohol, Glyceryl Stearate Citrate, PEG-7 Trimethylolpropane Coconut Ether, Caprylyl Glycol, Sorbitan Isostearate, Polyquaternium-80, Glyceryl Caprylate, Didecyldimonium Chloride

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 marketedFeb 2023
Product typeHuman Otc Drug
Portfolio25 products on file

More NDCs from COOLA LLC labeler code 79753

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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 29 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 cause by the sun.

⏱️ Dosage and Administration 56 words ▾

Inactive ingredients Water, Caprylic/Capric Triglyceride, Dimethicone, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Juice Powder, Jasminum Sambac (Jasmine) Leaf Cell Extract, Theobroma Cacao (Cocoa) Seed Extract, Schinus Molle Extract, Niacinamide, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Propanediol, Butylene Glycol, Polyisobutene, Methylpropanediol, Cetearyl Alcohol, Glyceryl Stearate Citrate, PEG-7 Trimethylolpropane Coconut Ether, Caprylyl Glycol, Sorbitan Isostearate, Polyquaternium-80, Glyceryl Caprylate, Didecyldimonium Chloride

⚠️ Warnings 98 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 prodcut is swallowed, get medical help or contact Poison Control Center right away. 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 7 words ▾

DRUG FACTS Active ingredients Zinc Oxide 15.8%

🧪 Inactive Ingredients 56 words ▾

Inactive ingredients Water, Caprylic/Capric Triglyceride, Dimethicone, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Juice Powder, Jasminum Sambac (Jasmine) Leaf Cell Extract, Theobroma Cacao (Cocoa) Seed Extract, Schinus Molle Extract, Niacinamide, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Propanediol, Butylene Glycol, Polyisobutene, Methylpropanediol, Cetearyl Alcohol, Glyceryl Stearate Citrate, PEG-7 Trimethylolpropane Coconut Ether, Caprylyl Glycol, Sorbitan Isostearate, Polyquaternium-80, Glyceryl Caprylate, Didecyldimonium Chloride

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 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 doctor if skin rash occurs

📄 Keep Out of Reach of Children 21 words ▾

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

📄 Other Information 12 words ▾

Other information * protect this product from excessive heat and direct sun

📄 Questions or Comments 9 words ▾

Questions or comments? Call 760-940-2125

Questionsor Comments? Call 760-940-2125

📖 Instructions for Use 28 words ▾

How to use: Apply daily to cleansed skin, 15 minutes before sun exposure. Dispense into palm of hand and apply evenly across face and neck using upward strokes,

📄 Package Label / Principal Display Panel 42 words ▾

Package Labeling SPF 30 COOLA MINERAL SUN SILK CREME SUNSCREEN SPF 30

1.5FL OZ /44 mL ©2021 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool San Diego, CA 92010. All Rights Reserved. res 070-01 1.5Oz Box 070-01 1.5Oz Botle

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 — Not published for this NDC No photo available yet for this listing.
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.
← 79753-0069-01 · COOLA 79753-0073-02 · COOLA →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.