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PREDIRE PARIS skin shield protector mineral defense cream 8 g/100mL; 5 g/100mL; 3 g/100mL; 10 g/100mL Cream, 50 mL — NDC 83447-012-01 (Billing 83447-0012-01)

by Guangzhou Fantesy Biotechnology Co.,Ltd · 50 mL in 1 BOTTLE

This is a package of 50 mL of PREDIRE PARIS skin shield protector mineral defense cream 8 g/100mL; 5 g/100mL; 3 g/100mL; 10 g/100mL Cream from Guangzhou Fantesy Biotechnology Co.,Ltd, marketed since Jul 2025 and currently FDA-listed. It is this product's only package size.

NDC 83447-0012-01
🏷️ FDA NDC (as labeled) 83447-012-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83447-012-01
Product NDC 83447-012
11-digit billing NDC 83447001201
UNII 4X49Y0596W, V06SV4M95S, 4Y5P7MUD51, 5A68WGF6WM
Application # M020
SPL Set ID 3a7c1345-532f-b38f-e063-6394a90a5245
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-22
Route CUTANEOUS
Dosage form CREAM
Substance ETHYLHEXYL SALICYLATE; HOMOSALATE; ETHYLHEXYL METHOXYCINNAMATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 83447-012-01 — 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 → 83447-0012-01. 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?

Predire Paris Skin Shield Protector is an over-the-counter sunscreen cream applied to the skin. It contains four active ingredients (ethylhexyl methoxycinnamate, ethylhexyl salicylate, homosalate, and octocrylene) that function as ultraviolet light absorbers. These chemical UV filters are commonly used together in sunscreen products to help protect skin from sun exposure. As an OTC monograph drug, this product is marketed under FDA's established rules for sunscreen ingredients rather than as an individually approved application.

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
83447-0012-01 You're viewing this Main listing 50 mL in 1 BOTTLE 2025-07-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
PREDIRE PARIS skin shield protector mineral defense cream 8 g/100mL; 5 g/100mL; 3 g/100mL; 10 g/100mLthis 83447-0012-01 Guangzhou 50 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
Jul 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 W59H9296ZG
    A synthetic polymer made from acrylic compounds and vinylpyrrolidone. It works as a film-former and thickener in topical products, helping create a smooth texture and improve how the medication spreads on skin.
  • 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 PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII 3SCV180C9W
    Betaine is a naturally occurring organic compound found in plants and animals. In medicines, it acts as an osmoprotectant and stabilizer, helping maintain the product's moisture balance and preserve its chemical stability during storage.
  • UNII E4F12ROE70
    A refined mineral oil derived from crude petroleum containing 13 to 14 carbon chains. It acts as a solvent, emollient, and carrier in topical formulations to help dissolve active ingredients and improve product texture and spreadability.
  • 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 8JC99XGU4W
    Soluble fish skin collagen is a protein derived from fish skin that acts as a binder and thickening agent in medicines. It helps hold ingredients together and gives the product the right texture or consistency.
  • 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 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 S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • UNII Z95S6G8201
    A synthetic surfactant derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oily and watery ingredients in liquid formulations, and may improve how the medicine spreads or is absorbed.
  • UNII 3OKE88I3QG
    A natural flavoring derived from peach fruit. It enhances taste in oral medicines to make them more palatable, especially for patients who might otherwise resist taking the medication.
  • UNII P5QZM4T259
    A synthetic polymer made from polyethylene glycol and polypropylene glycol chains. It acts as a binder and film-former to help hold tablet ingredients together and create protective coatings on medications.
  • 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 5D6TC4BRWV
    Polyacrylamide is a synthetic polymer used as a thickener and stabilizer in medicines. It helps maintain consistent texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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.

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

The official label also statesWater, Glycerin, Propylene Glycol, Collagen, Caprylic/Capric Triglyceride, Vitamin C, PEG/PPG- 17 / 6 Copolymer, Hyaluronic Acid, Betaine, Ammonium Acryloyldimethyltaurate/vp Copolymer, Tocopherol, Polyacrylamide, lron oxides, C13- 14 Isoparaffin, Laureth-7, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Fragrance, Phenoxyethanol.

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

LabelerGuangzhou Fantesy Biotechnology Co.,Ltd
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code83447
First marketedJul 2025
Product typeHuman Otc Drug
Portfolio14 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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 29 words ▾

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

⏱️ Dosage and Administration 18 words ▾

Directions Apply liberally 15 minutes before sun exposure. Reapply every two hours. Water- resistant up to 40 minutes.

⚠️ Warnings 5 words ▾

Warnings For external use only.

📦 Storage and Handling 6 words ▾

Other information Store at room temperature

🧪 Active Ingredient 12 words ▾

Active ingredients Octocrylene 10% Ethylhexyl Salicylate 8% Homosalate 5% Ethylhexyl Methoxycinnamate 3%

🧪 Inactive Ingredients 37 words ▾

Inactive ingredients Water, Glycerin, Propylene Glycol, Collagen, Caprylic/Capric Triglyceride, Vitamin C, PEG/PPG- 17 / 6 Copolymer, Hyaluronic Acid, Betaine, Ammonium Acryloyldimethyltaurate/vp Copolymer, Tocopherol, Polyacrylamide, lron oxides, C13- 14 Isoparaffin, Laureth-7, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Fragrance, Phenoxyethanol.

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 11 words ▾

Do not use Do not use on damaged or broken skin.

📄 When Using This Product 17 words ▾

When using this product When using this product, keep out of eyes. Rinse with water to remove.

📄 Stop Use and Ask a Doctor If 11 words ▾

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

📄 Keep Out of Reach of Children 26 words ▾

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

📄 Package Label / Principal Display Panel 1 words ▾

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

About this NDC listing & data coverage

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

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Guangzhou Fantesy Biotechnology Co.,Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Guangzhou Fantesy Biotechnology Co.,Ltd 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.
← 83447-0011-01 · Guangzhou 83447-0013-01 · Guangzhou →
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.