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Reef safe - Zinc Face sunscreen SPF50 Zinc Oxide 25 kg/100kg Cream, 009 kg — NDC 83252-0109-27 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Reef safe - Zinc Face sunscreen SPF50 Zinc Oxide 25 kg/100kg Cream, 009 kg — NDC 83252-109-27 (Billing 83252-0109-27)

by VEGANIC SKN LIMITED · .009 kg in 1 POUCH

This is a package of 009 kg of Reef safe - Zinc Face sunscreen SPF50 Zinc Oxide 25 kg/100kg Cream from VEGANIC SKN LIMITED, marketed since Jun 2025 and currently FDA-listed.

NDC 83252-0109-27
🏷️ FDA NDC (as labeled) 83252-109-27 billing pads the product segment with a zero
This package
Contains009 kg Pack sizes4 compare ↓
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 →

NDC database record

One package, one record: these facts belong to NDC 83252-109-27 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
83252 labeler · 109 product · 27 package
Package marketed since
Jun 25, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
9337907073297
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83252-109-27
Product NDC 83252-109
11-digit billing NDC 83252010927
UNII SOI2LOH54Z
UPC 9337907073297
Application # M020
SPL Set ID 385f0f79-016f-71a7-e063-6394a90a9286
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-25
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 83252-109-27 — 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 → 83252-0109-27. 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 cream sunscreen containing zinc oxide, an over-the-counter monograph product marketed under FDA category rules. Zinc oxide is a mineral UV filter typically used in sunscreens to help block ultraviolet rays from the sun. The product is formulated as a cream intended for application to the face and is labeled as reef safe, meaning it is designed to avoid ingredients that may harm coral ecosystems. This cream contains 25 percent zinc oxide by weight.

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.
Try another pack size: 1 kg 11 kg 036 kg
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
83252-0109-00 83252-109-00 Main listing .11 kg in 1 BOTTLE, PUMP 2025-06-25 — Active
83252-0109-02 83252-109-02 .036 kg in 1 BOTTLE, PUMP 2025-06-25 — Active
83252-0109-25 83252-109-25 .1 kg in 1 BOTTLE, PUMP 2025-06-25 — Active
83252-0109-27 You're viewing this .009 kg in 1 POUCH 2025-06-25 — Active

Pack size FAQ

What quantity is in this package?
This package contains 009 kg — .009 kg in 1 pouch.
How does this package differ from NDC 83252-0109-25?
Both are Reef safe - Zinc Face sunscreen SPF50 Zinc Oxide 25 kg/100kg Cream — the drug itself is identical. This page's package is the 009 kg one, while NDC 83252-0109-25 is the 1 kg package.
What NDC number is used to bill for this package of Reef safe - Zinc Face sunscreen SPF50 Zinc Oxide 25 kg/100kg Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
AussieZinc Mineral Sunscreen Vegan and Organic Anti-Aging - Light Tint 25 kg/100kg 83252-0097-00 VEGANIC 11 kg — — FDA listed —
Sun Zapper - Face pure zinc sunscreen SPF30 25 kg/100kg 83252-0125-25 VEGANIC 1 kg — — FDA listed —
Oze Sun Mineral Sunscreen SPF50 25 kg/100kg 83252-0129-15 VEGANIC 2 kg — — FDA listed —
Binda Botanicals Baby and Kids Sunscreen SPF50 25 kg/100kg 83252-0142-21 VEGANIC 1 kg — — FDA listed —
Reef safe - Zinc Sport sunscreen SPF50 25 kg/100kg 83252-0113-02 VEGANIC 036 kg — — FDA listed —
Reefsun sunscreen SPF50 25 kg/100kg 83252-0117-03 VEGANIC 1 kg — — FDA listed —
Zinc FIVE-0 baby and kids mineral sunscreen SPF50 25 kg/100kg 83252-0119-03 VEGANIC 1 kg — — FDA listed —
Oze Sun reef safe Sunscreen SPF50 25 kg/100kg 83252-0130-25 VEGANIC 1 kg — — FDA listed —
AussieZinc Mineral Sunscreen Vegan and Organic Everyday 25 kg/100kg 83252-0098-00 VEGANIC 11 kg — — FDA listed —
Reef safe - Vitamin C sunscreen SPF50 25 kg/100kg 83252-0108-01 VEGANIC 07 kg — — FDA listed —
Marie originals - ProActive Sunscreen 25 kg/100kg 83252-0152-25 VEGANIC 1 kg — — FDA listed —
Koobarra Mineral Face Sunscreen SPF 50 25 kg/100kg 83252-0104-25 VEGANIC 1 kg — — FDA listed —
Reef safe - Face and Body sunscreen SPF50 25 kg/100kg 83252-0114-15 VEGANIC 2 kg — — FDA listed —
EcoZinc x DSO Welders 98 percent UVC Protection Sunscreen for Welding 25 kg/100kg 83252-0115-15 VEGANIC 2 kg — — FDA listed —
Sun Zapper - Anti-ageing pure zinc sunscreen SPF30 25 kg/100kg 83252-0128-25 VEGANIC 1 kg — — FDA listed —
Soodox Natural Mineral Sunscreen SPF50 - 7 years to adult 25 kg/100kg 83252-0131-25 VEGANIC 1 kg — — FDA listed —
EcoZinc Kids Natural Mineral Sunscreen SPF50 25 kg/100kg 83252-0134-15 VEGANIC 2 kg — — FDA listed —
Lotus Harmony - Quinn Shield Sunscreen SPF50 25 kg/100kg 83252-0145-25 VEGANIC 1 kg — — FDA listed —
AussieZinc Mineral Sunscreen Vegan and Organic Kids 25 kg/100kg 83252-0096-00 VEGANIC 11 kg — — FDA listed —
Les Duets - Shield of Helios, sunscreen SPF50 25 kg/100kg 83252-0111-01 VEGANIC 07 kg — — FDA listed —
BINDA Face and Body Sunscreen SPF50 25 kg/100kg 83252-0118-21 VEGANIC 1 kg — — FDA listed —
BINDA Vitamin C and hyaluronic acid Sunscreen SPF50 25 kg/100kg 83252-0120-00 VEGANIC 11 kg — — FDA listed —
AussieZinc Mineral Sunscreen Vegan and Organic Mozzie Repellant 25 kg/100kg 83252-0101-00 VEGANIC 11 kg — — FDA listed —
ReefSafe Very High Sun Protection sunscreen 25 kg/100kg 83252-0137-25 VEGANIC 1 kg — — FDA listed —
Safe4Kidz Baby Zinc Sunscreen SPF50 25 kg/100kg 83252-0140-25 VEGANIC 1 kg — — FDA listed —
Oze Sun Bondi 25 kg/100kg 83252-0144-15 VEGANIC 2 kg — — FDA listed —
Reef safe - acne-prone sunscreen SPF50 25 kg/100kg 83252-0107-01 VEGANIC 07 kg — — FDA listed —
Reef safe - Zinc Face sunscreen SPF50 25 kg/100kgthis 83252-0109-27 VEGANIC 009 kg — — FDA listed —
EcoZinc Natural Mineral Sunscreen SPF50 25 kg/100kg 83252-0112-00 VEGANIC 11 kg — — FDA listed —
Sun Zapper - Kids pure zinc sunscreen SPF50 25 kg/100kg 83252-0123-25 VEGANIC 1 kg — — FDA listed —
Lekura - ZincDaily Natural Face Sunscreen SPF50 25 kg/100kg 83252-0151-25 VEGANIC 1 kg — — FDA listed —
AussieZinc Mineral Sunscreen Vegan and Organic Extra Sensitive 25 kg/100kg 83252-0100-00 VEGANIC 11 kg — — FDA listed —
Soodox Natural Mineral Sunscreen SPF50 - 6 months to 6 years 25 kg/100kg 83252-0132-25 VEGANIC 1 kg — — FDA listed —
ReefSafe Baby and Toddlers Sunscreen SPF50 25 kg/100kg 83252-0136-25 VEGANIC 1 kg — — FDA listed —
AussieZinc Mineral Sunscreen Vegan and Organic Hydrate and Nourish - Medium Tint 25 kg/100kg 83252-0099-00 VEGANIC 11 kg — — FDA listed —
Reef safe - Hydrating sunscreen SPF50 25 kg/100kg 83252-0106-00 VEGANIC 11 kg — — FDA listed —
Reef safe - Baby zinc sunscreen SPF50 25 kg/100kg 83252-0110-01 VEGANIC 07 kg — — FDA listed —
Thermasun SPF50 Mineral Zinc facial sunscreen 25 kg/100kg 83252-0116-28 VEGANIC 12 kg — — FDA listed —
Sun Zapper - Baby pure zinc sunscreen SPF30 25 kg/100kg 83252-0126-25 VEGANIC 1 kg — — FDA listed —
Safe4Kidz Natural Mineral Sunscreen SPF50 25 kg/100kg 83252-0138-15 VEGANIC 2 kg — — FDA listed —
Sparms 100% Organic Face Sunscreen 25 kg/100kg 83252-0143-01 VEGANIC 07 kg — — FDA listed —
Mama and Hapa s - Bulk Sunscreen Extra Sensitive 25 kg/100kg 83252-0153-26 VEGANIC 15 kg — — FDA listed —
Sun Zapper - Pure Zinc Anti Mozzie Sunscreen SPF50 25 kg/100kg 83252-0122-17 VEGANIC 24 kg — — 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 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII 18E7415PXQ
    A plant extract from calendula flowers used in topical formulations. It functions as a soothing botanical ingredient and may help support the product's skin-conditioning properties.
  • UNII WL0328HX19
    A natural plant-based wax derived from candelilla shrub leaves. It acts as a coating agent, hardener, and texture modifier to control how quickly the medicine releases and to improve the tablet or capsule's appearance and stability.
  • UNII 598D944HOL
    A natural oil extracted from grapefruit seeds, used as a flavoring agent and preservative to enhance taste and help prevent spoilage in medicines.
  • UNII 7626GC95E5
    A natural aromatic oil extracted from coriander seeds. Used as a flavoring agent to mask bitter tastes and improve the overall taste of medicines, making them easier to take.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • 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 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 T53SBG6741
    A plant-based oil extracted from sea buckthorn seeds. It's used as an emollient and skin-conditioning agent to soften the medicine's texture and improve how it feels or spreads on skin.
  • UNII X33R8U0062
    Isostearic acid is a fatty acid derived from vegetable oils. It acts as an emulsifier and lubricant in medicines, helping blend ingredients together and reducing friction during tablet or capsule manufacturing.
  • 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 0ZQ1D2FDLI
    A fruit extract from the kakadu plum tree, native to Australia. It's used in formulations as a source of vitamin C and as an antioxidant to help preserve the medicine's stability.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII MZQ63P0N0W
    A plant-derived emulsifier made from glycerin and castor oil. It helps mix oil and water ingredients together in formulations like creams and lotions, keeping them blended.
  • 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 03KCY6P7UT
    A waxy compound derived from cetyl alcohol and phosphoric acid. It acts as an emulsifier to help blend oil and water ingredients, and as a thickener to give the medicine its proper texture and consistency.
  • UNII S033EH8359
    Sodium ascorbate is a salt form of vitamin C. It serves as an antioxidant to prevent degradation of other ingredients and as a pH buffer to maintain stable acidity in the medicine.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 5MPS47D679
    Sodium hinokitiol is a salt form of hinokitiol, a naturally derived antimicrobial compound. It's used in medicines as a preservative to prevent bacterial and fungal growth.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • 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 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.

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

The official label also statesSee ingredients on label

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

LabelerVEGANIC SKN LIMITED
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code83252
First marketedJun 2025
Product typeHuman Otc Drug
Portfolio49 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.

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 5 words ▾

kindly refer to label picture

⏱️ Dosage and Administration 4 words ▾

Kindly refer to Label

⚠️ Warnings 55 words ▾

For external use only. Do not use on damaged r broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if 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 4 words ▾

Zinc oxide - 25%

🧪 Inactive Ingredients 4 words ▾

See ingredients on label

🎯 Purpose 1 words ▾

Sunscreen

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Package Label / Principal Display Panel 12 words ▾

Label - 100g Label - 110g Label - 36g Sachet 9g (pouch)

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

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 Reef safe - Zinc Face sunscreen SPF50 (this brand).

Top reported reactions

Dry Skin1
Erythema1
Pruritus1
Skin Discomfort1
Skin Exfoliation1
Skin Fissures1
Skin Irritation1

Reporter sex

1 reports
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.

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 VEGANIC SKN LIMITED. 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 3 other package presentations of this same product, including 1 kg (83252-0109-25), 11 kg (83252-0109-00), 036 kg (83252-0109-02). 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?
VEGANIC SKN LIMITED 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.
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.