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ENVIRONMENTAL DEFENSE ZINC OXIDE 225 mg/100mL Cream, 60 mL — NDC 58518-0010-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ENVIRONMENTAL DEFENSE ZINC OXIDE 225 mg/100mL Cream, 60 mL — NDC 58518-010-02 (Billing 58518-0010-02)

by Avasol LLC · 60 mL in 1 POUCH

This is a package of 60 mL of ENVIRONMENTAL DEFENSE ZINC OXIDE 225 mg/100mL Cream from Avasol LLC, marketed since Jul 2013 and currently FDA-listed. It is this product's only package size.

NDC 58518-0010-02
🏷️ FDA NDC (as labeled) 58518-010-02 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 58518-010-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
58518 labeler · 010 product · 02 package
Package marketed since
Nov 29, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0798304287707
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) 58518-010-02
Product NDC 58518-010
11-digit billing NDC 58518001002
UNII SOI2LOH54Z
UPC 0798304287707
Application # M020
SPL Set ID 1fbddab4-71f7-4167-ad21-30040b7c71bb
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-07-18
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 58518-010-02 — 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 → 58518-0010-02. 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.

Clinical

🧪 What is this product?

Environmental Defense Zinc Oxide is a topical cream containing zinc oxide as its active ingredient. This is an over-the-counter monograph product, meaning it is marketed under FDA's established rules for this category of skin-care drug. Zinc oxide is commonly used in creams and ointments as a skin protectant and mild astringent, typically applied to the skin to help protect against minor irritation and moisture loss.

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
58518-0010-02 You're viewing this Main listing 60 mL in 1 POUCH 2021-11-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Environmental Defense 225 mg/100mLthis 58518-0010-02 Avasol 60 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

🏛️
2013
On the market since
Jul 2013
📍
2026
Currently FDA-listed
13 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 4V59G5UW9X
    Argan oil is a plant-derived oil from argan tree kernels. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
  • UNII XE54U569EC
    A natural essential oil extracted from cinnamon bark. It's used as a flavoring agent to mask bitter tastes and improve the flavor of medicines.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII G7036X8B5H
    A dark iron compound that gives medicine its color. Used as a colorant in tablets and capsules to help identify the medication and make it visually distinctive.
  • UNII 31T0FF0472
    A red microalgae used as a natural colorant and source of astaxanthin pigment in medications and supplements. It adds color to tablets and capsules.
  • 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 M6QU9ZUH2X
    A natural essential oil derived from the Manuka tree, used in medicines as a fragrance, flavor enhancer, and preservative to improve product appeal and shelf stability.
  • UNII 83ULF8L5FI
    A plant-derived ingredient from the Mauritia flexuosa palm tree. It serves as a natural filler or binder to add bulk and help hold tablet or capsule ingredients together.
  • 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 V8A1AW0880
    Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
  • UNII 6Y8XYV2NOF
    A waxy substance made by honeybees from plant resins and pollen. In medicines, it acts as a binder and coating agent to hold ingredients together and protect the product.
  • UNII IJ67X351P9
    A natural plant extract from rosemary leaves used as a preservative to help prevent oils and fats in the medicine from spoiling or becoming rancid during storage.
  • UNII M3CL7US2ZG
    A natural plant extract from red raspberry seeds. It's used as an antioxidant and flavoring agent to help preserve the medicine and improve its taste.
  • UNII 84H6HBP32L
    A natural fat extracted from shea tree nuts, used as an emollient and lubricant in formulations to improve texture, aid ingredient mixing, and help the medicine spread or absorb smoothly.
  • 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 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII JT3LVK84A1
    A plant-based oil extracted from tamanu tree nuts, used as an emollient and skin-conditioning agent in topical formulations. It helps soften and moisturize the product's texture.
  • UNII Q7RNT1G37V
    A plant-based ingredient derived from cacao tree seeds, used as a natural fat or cocoa butter substitute. It serves as a binder and filler in solid dosage forms and helps with texture and consistency in tablets or capsules.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII Q74T35078H
    Vanilla is a flavoring ingredient extracted from vanilla orchid beans. It's added to medicines to improve taste and make them more pleasant to take, especially for children or patients who need liquid formulations.
  • 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.

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

The official label also statesCaprylic/Capric Triglyceride (Coconut), *Simmondsia Chinensis (Jojoba) Seed Oil,*Helianthus annuus (Sun flower) Oil,*Cocos Nucifera (Coconut) Oil,*Calophyllum Inophyllum (Tamanu)Oil,*Argania spinosa (Argan) Oil, Silica, *Beeswax,*Theobroma Grandiflorum (Cupuacu) Seed Butter,*Butyrospermum parkii (Shea Butter),**Mauritia Flexuosa (Buriti) Fruit Oil, Rubus idaeus (Raspberry) Seed Oil, Tocopherol (Vitamin E), Mica, Iron oxides, *Vanilla Planifolia(Vanilla) Fruit Extract, Plankton Extract,*Propolis,*Rosmarinus Officinalis (Rosemary) Leaf Extract,**Leptospermum scoparium (Manuka)Oil, *Cinnamomum Zeylanicum (Cinnamon) Bark Oil, Love. *Organic **Wildcrafted

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

LabelerAvasol LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code58518
First marketedJul 2013
Product typeHuman Otc Drug
Portfolio4 products on file

More NDCs from Avasol LLC labeler code 58518

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 📄 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 4 words ▾

Uses Helps prevent sunburn

⏱️ Dosage and Administration 36 words ▾

Directions Apply liberally before sun Reapply: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours, or as needed Children under 6 months: Ask a doctor May stain some fabrics.

⚠️ Warnings 55 words ▾

Warnings For external use only Keep out of eyes. Rinse with water to remove Stop use and ask a doctor if rash or irritation occurs. Do not use if allergic to ingredients. Test small area first. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 6 words ▾

Active Ingredients Zinc Oxide (Non-nano) 22.5%

🧪 Inactive Ingredients 66 words ▾

Inactive ingredients Caprylic/Capric Triglyceride (Coconut), *Simmondsia Chinensis (Jojoba) Seed Oil,*Helianthus annuus (Sun flower) Oil,*Cocos Nucifera (Coconut) Oil,*Calophyllum Inophyllum (Tamanu)Oil,*Argania spinosa (Argan) Oil, Silica, *Beeswax,*Theobroma Grandiflorum (Cupuacu) Seed Butter,*Butyrospermum parkii (Shea Butter),**Mauritia Flexuosa (Buriti) Fruit Oil, Rubus idaeus (Raspberry) Seed Oil, Tocopherol (Vitamin E), Mica, Iron oxides, *Vanilla Planifolia(Vanilla) Fruit Extract, Plankton Extract,*Propolis,*Rosmarinus Officinalis (Rosemary) Leaf Extract,**Leptospermum scoparium (Manuka)Oil, *Cinnamomum Zeylanicum (Cinnamon) Bark Oil, Love. *Organic **Wildcrafted

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 11 words ▾

Do not use if allergic to ingredients. Test small area first.

📄 Stop Use and Ask a Doctor If 11 words ▾

Stop use and ask a doctor if rash or irritation occurs.

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Other Information 9 words ▾

Other information Shake well before use. Warm as needed.

📄 Questions or Comments 6 words ▾

Questions? Call 888-805-1507 or visit www.avasol.com

📄 Package Label / Principal Display Panel 29 words ▾

Principal Display Panel - 2 Fl Oz Bottle Label avasol ® mineral sunscreen 30 SPF 2 FL OZ (59 mL) Principal Display Panel - 2 Fl Oz Bottle Label

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 Avasol LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Avasol 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.
← 58503-0213-01 · China 58518-0020-03 · Avasol →
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.