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TALLOW SUNSCREEN Non-Nano Zinc Oxide 25 mg/100mL Cream, 100 mL — NDC 85739-0001-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

TALLOW SUNSCREEN Non-Nano Zinc Oxide 25 mg/100mL Cream, 100 mL — NDC 85739-001-01 (Billing 85739-0001-01)

by FOUNDATION COMMERCE INC · 100 mL in 1 CARTON

This is a package of 100 mL of TALLOW SUNSCREEN Non-Nano Zinc Oxide 25 mg/100mL Cream from FOUNDATION COMMERCE INC, marketed since Jun 2025 and currently FDA-listed. It is this product's only package size.

NDC 85739-0001-01
🏷️ FDA NDC (as labeled) 85739-001-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 85739-001-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
85739 labeler · 001 product · 01 package
Package marketed since
Jun 19, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8573900101 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85739-001-01
Product NDC 85739-001
11-digit billing NDC 85739000101
UNII SOI2LOH54Z
Application # M020
SPL Set ID 363e38bf-b4b4-dcc4-e063-6294a90a5d2f
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-19
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 85739-001-01 — 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 → 85739-0001-01. 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 topical sunscreen cream containing zinc oxide as the active ingredient. Zinc oxide is a mineral UV filter commonly used in sunscreen products to help reflect and scatter ultraviolet light away from the skin. This product is marketed as an over-the-counter drug under FDA's monograph rules for sunscreen ingredients, meaning it follows established safety and effectiveness standards for that category rather than undergoing individual product review.

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.

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
85739-0001-01 You're viewing this Main listing 100 mL in 1 CARTON 2025-06-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tallow Sunscreen 25 mg/100mLthis 85739-0001-01 FOUNDATION 100 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year 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 98HPY76U4W
    Beef tallow is a fat rendered from cattle tissue. It's used in medicines as a lubricant and binder to help tablets form properly and slide through machinery during manufacturing.
  • UNII 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII 8U5D034955
    Calcium disodium EDTA is a chemical compound that binds to metal ions. It's used in medicines as a stabilizer to prevent discoloration and maintain ingredient freshness during storage.
  • 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 MCU2324216
    A silicone-based oil that reduces foaming and helps ingredients mix evenly. It's used as an antifoaming agent and lubricant in tablets, capsules, and liquid formulations.
  • 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 S4V5BS6GCX
    A synthetic oily liquid used as an emollient and solvent in topical medications. It helps dissolve active ingredients and creates a smooth, spreadable texture on the skin.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII D2QHA03458
    A fermented ingredient made by culturing beneficial bacteria in radish root extract. It acts as a natural preservative and humectant, helping keep the product fresh and maintain moisture in the formula.
  • UNII 6UYK2W1W1E
    A natural oil extracted from olives. It acts as an emollient and lubricant in formulations, helping to soften ingredients and improve how the medicine spreads or flows.
  • UNII 6DRV3D37XS
    A plant extract from Chinese lizard's tail (Saururus chinensis), used in traditional herbal preparations. It serves as an active botanical ingredient that may provide therapeutic properties, though its specific formulation role in this product depends on the medicine's intended use.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII 9DE5YCO0RU
    A plant extract from dandelion root traditionally used in herbal preparations. In medications, it may serve as a flavor enhancer, natural colorant, or bitter component that supports formulation taste and appearance.
  • UNII O03S90U1F2
    A synthetic compound combining vitamin E with polyethylene glycol and succinic acid. It acts as a solubilizer and antioxidant in medicines, helping dissolve poorly water-soluble drugs and prevent degradation of active ingredients.
  • 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.

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

The official label also statesWater, Beef Tallow, Beeswax, Butyrospermum Parkii {Shea)Butter, Vitamin E, Simmondsia Chinensis (Jojoba) seed oll, OleaEuropaea (Olive) Fruit Oil, Lecithin,C12-15 Alkyl Benzoate, Silica,Squalane, Xanthan Gum, Dimethicone, Glyceryl Stearate,Cetearyl Alcohol, lsononyi lsononanoate, Disodium EDTA, RadishRoot Ferment Filtrate, Saururus Chinensis Leaf/root Extract,Taraxacum Offcinale (Dandelion) Leaf Extract

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

LabelerFOUNDATION COMMERCE INC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code85739
First marketedJun 2025
Product typeHuman Otc Drug
Portfolio6 products on file

More NDCs from FOUNDATION COMMERCE INC labeler code 85739

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 27 words ▾

Helps prevent sunburn If used as directed with othersun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

⏱️ Dosage and Administration 84 words ▾

Apply liberally 15 minutes belore 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 sunincreases your risk of skin cancer and eariy skin aging. Todecrease this risk, regularly use a sunscreen wiih a BroadSpectrum SPF value ot 15 or higher and other sunprotection 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 ofage: Ask a doclor

⚠️ Warnings 39 words ▾

For external use only on damaged or broken skin Keep out of eyes. Rinse with water to remowe. Ask a doctor if rash occurs. lf product is swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 4 words ▾

Non-Nano Zinc Oxide 25%

🧪 Inactive Ingredients 43 words ▾

Water, Beef Tallow, Beeswax, Butyrospermum Parkii {Shea)Butter, Vitamin E, Simmondsia Chinensis (Jojoba) seed oll, OleaEuropaea (Olive) Fruit Oil, Lecithin,C12-15 Alkyl Benzoate, Silica,Squalane, Xanthan Gum, Dimethicone, Glyceryl Stearate,Cetearyl Alcohol, lsononyi lsononanoate, Disodium EDTA, RadishRoot Ferment Filtrate, Saururus Chinensis Leaf/root Extract,Taraxacum Offcinale (Dandelion) Leaf Extract

🎯 Purpose 1 words ▾

Sunscreen

📄 Do Not Use 5 words ▾

on damaged or broken skin

📄 When Using This Product 9 words ▾

Keep out of eyes. Rinse with water to remowe.

📄 Stop Use and Ask a Doctor If 6 words ▾

Ask a doctor if rash occurs.

📄 Keep Out of Reach of Children 15 words ▾

lf product is swallowed, get medical help or contact a Poison Control Center right away.

📄 Other Information 12 words ▾

Protect the product in this container from excessive heat and direct sun

📄 Questions or Comments 1 words ▾

servicegvigority.com

📄 Package Label / Principal Display Panel 1 words ▾

Sunscreen

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

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by FOUNDATION COMMERCE INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
FOUNDATION COMMERCE INC 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.
← 85738-0226-15 · Skintique 85739-0002-01 · FOUNDATION →
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.