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Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40 TITANIUM DIOXIDE, ZINC OXIDE 78 mg/mL; 250 mg/mL Lotion — NDC 63730-0001-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40 TITANIUM DIOXIDE, ZINC OXIDE 78 mg/mL; 250 mg/mL Lotion — NDC 63730-001-04 (Billing 63730-0001-04)

by NATURA BISSE INTERNATIONAL SA · 1 TUBE in 1 BOX / 30 mL in 1 TUBE

This is a package of Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40 TITANIUM DIOXIDE, ZINC OXIDE 78 mg/mL; 250 mg/mL Lotion from NATURA BISSE INTERNATIONAL SA, marketed since Jun 2021 and currently FDA-listed.

NDC 63730-0001-04
🏷️ FDA NDC (as labeled) 63730-001-04 billing pads the product segment with a zero
This package
Contains30 mL in 1 tube 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 63730-001-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
63730 labeler · 001 product · 04 package
Package marketed since
Jun 1, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
8435624501138, 8435624501121
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Titanium Dioxide, Zinc Oxide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 3, 2024 — Microbial Contamination of Non-Sterile Product (Vivier Pharma, Inc.) · FDA recall D-0662-2024
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) 63730-001-04
Product NDC 63730-001
11-digit billing NDC 63730000104
UNII 15FIX9V2JP, SOI2LOH54Z
UPC 8435624501138, 8435624501121
Application # M020
SPL Set ID bf8b71c7-257b-0eb6-e053-2a95a90a3a4c
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-06-01
Route TOPICAL
Dosage form LOTION
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 63730-001-04 — 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 → 63730-0001-04. 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 light tinted sunscreen lotion applied to the skin to help protect against ultraviolet (UV) radiation from the sun. It contains titanium dioxide and zinc oxide, which are mineral UV-blocking agents that work by sitting on top of the skin and reflecting UV rays away. This product is marketed as an over-the-counter sunscreen under FDA's established monograph rules for sunscreen products and carries a broad-spectrum SPF 40 rating.

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: 10 mL 30 mL 4 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63730-0001-01 63730-001-01 Main listing 4 mL in 1 PACKET Sample 2021-06-01 — Active
63730-0001-02 63730-001-02 1 TUBE in 1 BOX / 10 mL in 1 TUBE Sample 2021-06-01 — Active
63730-0001-03 63730-001-03 1 TUBE in 1 BOX / 30 mL in 1 TUBE 2021-06-01 — Active
63730-0001-04 You're viewing this 1 TUBE in 1 BOX / 30 mL in 1 TUBE 2021-06-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 box / 30 ml in 1 tube.
What NDC number is used to bill for this package of Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40 TITANIUM DIOXIDE, ZINC OXIDE 78 mg/mL; 250 mg/mL Lotion?
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
Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40 78 mg/mL; 250 mg/mLthis 63730-0001-04 NATURA 1 tube — — 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

🏛️
2021
On the market since
Jun 2021
📍
2026
Currently FDA-listed
5 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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
  • UNII QN83US2B0N
    Ascorbyl palmitate is a fat-soluble form of vitamin C used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down and becoming less stable over time.
  • 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 CI87N1IM01
    A mixture of liquid hydrocarbons derived from petroleum, used as a lubricant and glidant to help the medicine flow smoothly during manufacturing and ensure even tablet coating or capsule filling.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 4828G836N6
    A plant-derived oil mixture from coconut that acts as an emollient and solvent. It helps dissolve or carry active ingredients and improves how the medicine spreads or absorbs in topical formulations.
  • UNII J8T3X564IH
    A clear oily liquid derived from sebacic acid, used as a plasticizer and solvent in pharmaceutical coatings and films to improve flexibility and help active ingredients dissolve properly.
  • 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 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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 K3Z4F929H6
    Lysine is an amino acid that serves as a buffer and pH regulator in medications. It helps maintain the medicine's stability and proper acidity level during storage and use.
  • UNII 02F3473H9O
    A mineral salt used in medications as a source of magnesium. It helps bind ingredients together, improve texture, and maintain the product's stability during storage.
  • 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 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 9713Q0S7FO
    A synthetic emulsifier derived from polyethylene glycol and fatty acids. It helps blend water and oil-based ingredients together in the formulation, improving texture and stability.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII M51422LRAM
    Polyglycerin-6 is a synthetic compound made from glycerin molecules linked together. In medicines, it acts as an emulsifier and humectant, helping mix oil and water-based ingredients and retain moisture in the formulation.
  • UNII YPM0ZOC2HR
    A synthetic emulsifier derived from glycerin and castor oil. It helps mix oil and water-based ingredients together in the formulation to create a uniform product and improve texture.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • 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 8D08K3S51E
    Propylene carbonate is a clear liquid solvent derived from propylene. It helps dissolve or suspend active ingredients in liquid medicines and can improve how well the product flows and mixes.
  • 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 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 NCX1UU2D33
    Sodium lauroyl glutamate is a mild cleanser derived from coconut oil and the amino acid glutamate. In medicines, it acts as a surfactant and emulsifier to help mix oily and watery ingredients and improve how the product spreads or dissolves.
  • UNII OLX698AH5P
    A clay mineral processed with a quaternary ammonium compound. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and 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 LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • 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.

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

The official label also statesWater, C15-19 Alkane, Butyloctyl Salicylate, Niacinamide, Dimethicone, Coco-Caprylate Propanediol, PEG-30 Dipolyhydroxystearate, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyricinoleate, Polyglyceryl-6 Polyhydroxystearate, Diisopropyl Sebacate, Polyhydroxystearic Acid, Sodium Chloride, Silica, Tocopheryl Acetate, Arginine, Artemia Extract, Tocopherol, Lysine, Ascorbyl Palmitate,Triethoxycaprylylsilane, Stearalkonium Hectorite, Polyglycerin-6, Disodium EDTA, Propylene Carbonate, Cetyl Alcohol, Ethylhexylglycerin, Sodium Lauroyl Glutamate, Magnesium Chloride, Phenoxyethanol, Potassium Sorbate, Fragrance, Iron Oxides.

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

LabelerNATURA BISSE INTERNATIONAL SA
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code63730
First marketedJun 2021
Product typeHuman Otc Drug
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 30 words ▾

Uses helps prevent sunburn. If used as directed with other sun protection measures (see ) decreases the risk of skin cancer and early skin aging caused by the sun. Directions

⏱️ Dosage and Administration ~1 min read ▾

Directions apply liberally 15 minutes before sun exposure. 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: Sun Protection Measures. 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: Ask a doctor reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating.

Directions have changed from: apply liberally 15 minutes before sun exposure. reapply: 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: Sun Protection Measures. To: apply liberally 15 minutes before sun exposure.

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: after 40 minutes of swimming or sweating Immediately after tower drying at least every 2 hours. 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 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: Ask a doctor reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating.

⚠️ Warnings 53 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 a doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

🧪 Active Ingredient 10 words ▾

Active ingredients Titanium dioxide 7.8% Zinc oxide 25% Purpose Sunscreen

🧪 Inactive Ingredients 56 words ▾

Inactive ingredients Water, C15-19 Alkane, Butyloctyl Salicylate, Niacinamide, Dimethicone, Coco-Caprylate Propanediol, PEG-30 Dipolyhydroxystearate, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyricinoleate, Polyglyceryl-6 Polyhydroxystearate, Diisopropyl Sebacate, Polyhydroxystearic Acid, Sodium Chloride, Silica, Tocopheryl Acetate, Arginine, Artemia Extract, Tocopherol, Lysine, Ascorbyl Palmitate,Triethoxycaprylylsilane, Stearalkonium Hectorite, Polyglycerin-6, Disodium EDTA, Propylene Carbonate, Cetyl Alcohol, Ethylhexylglycerin, Sodium Lauroyl Glutamate, Magnesium Chloride, Phenoxyethanol, Potassium Sorbate, Fragrance, Iron Oxides.

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin

📄 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 a doctor if rash occurs

📄 Keep Out of Reach of Children 18 words ▾

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

📄 Questions or Comments 8 words ▾

Questions? 1-800-762-8872 M-F 9:00 AM to 5:00 PM

📄 Recent Major Changes 183 words ▾

Directions have changed from: apply liberally 15 minutes before sun exposure. reapply: 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: Sun Protection Measures. To: apply liberally 15 minutes before sun exposure.

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: after 40 minutes of swimming or sweating Immediately after tower drying at least every 2 hours. 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 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: Ask a doctor reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating.

📄 Package Label / Principal Display Panel 34 words ▾

Package Labeling:63730-001-01 63730-001-01 Label

Package Labeling:63730-001-02 63730-001-02 inner label 63730-001-02 label 63730-001-02 outer label

Package Labeling:63730-001-03 63730-001-03 outer label 63730-001-03 inner label 63730-001-03 label

Package Labeling:63730-001-04 63730-001-04 outer label 63730-001-04 inner label 63730-001-04 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 NATURA BISSE INTERNATIONAL SA. 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 tube (63730-0001-02), 1 tube (63730-0001-03), 4 ml (63730-0001-01). 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?
NATURA BISSE INTERNATIONAL SA 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.