Face Reality Brilliant Defense Sunscreen SPF 50 OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE 90 mg/mL; 60 mg/mL; 50 mg/mL; 30 mg/mL Cream, 60 mL — NDC 70707-0455-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Face Reality Brilliant Defense Sunscreen SPF 50 OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE 90 mg/mL; 60 mg/mL; 50 mg/mL; 30 mg/mL Cream, 60 mL — NDC 70707-455-01 (Billing 70707-0455-01)

by Face Reality,LLC · 60 mL in 1 TUBE

This is a package of 60 mL of Face Reality Brilliant Defense Sunscreen SPF 50 OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE 90 mg/mL; 60 mg/mL; 50 mg/mL; 30 mg/mL Cream from Face Reality,LLC, marketed since Nov 2025 and currently FDA-listed. It is this product's only package size.

NDC 70707-0455-01
🏷️ FDA NDC (as labeled) 70707-455-01 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 →

NDC database record

One package, one record: these facts belong to NDC 70707-455-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70707 labeler · 455 product · 01 package
Package marketed since
Nov 15, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7070745501 5
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70707-455-01
Product NDC 70707-455
11-digit billing NDC 70707045501
UNII 5A68WGF6WM, V06SV4M95S, 4X49Y0596W, G63QQF2NOX
Application # M020
SPL Set ID 618f58b7-2f29-4dff-8c3a-4fdbe1eb8ce4
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-15
Route TOPICAL
Dosage form CREAM
Substance OCTOCRYLENE; HOMOSALATE; OCTISALATE; AVOBENZONE
Why two NDCs? The FDA registers this code as 70707-455-01 — 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 → 70707-0455-01. 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?

Face Reality Brilliant Defense Sunscreen SPF 50 is a topical cream containing four active ingredients that function as ultraviolet (UV) filters. Avobenzone, homosalate, octisalate, and octocrylene are organic sun-blocking agents commonly used together in sunscreen products to help absorb and scatter UVA and UVB rays from the sun. This is an over-the-counter monograph product, meaning it is marketed under FDA's established rules for sunscreen ingredients and formulations rather than as an individually reviewed application.

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
70707-0455-01 You're viewing this Main listing 60 mL in 1 TUBE 2025-11-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Face Reality Brilliant Defense Sunscreen SPF 50 90 mg/mL; 60 mg/mL; 50 mg/mL; 30 mg/mLthis 70707-0455-01 Face 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

🏛️
2025
On the market since
Nov 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 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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII 290O2PQ83R
    A stabilized form of vitamin C used in topical products as an antioxidant ingredient. It helps prevent degradation of other active ingredients and maintains product stability during storage.
  • UNII 3M5V3D1X36
    A plant extract from bearberry leaves, used in traditional medicine formulations. It may function as a natural flavoring agent or botanical additive in some preparations.
  • UNII S347WMO6M4
    Beta-sitosterol is a plant-derived sterol (waxy substance from vegetable oils and seeds). In medicines, it acts as an emulsifier or thickening agent to help blend oil and water-based ingredients and improve texture.
  • UNII CH47CU874T
    A synthetic polymer made from fatty acid derivatives and propanediol. It works as a film-former and texture enhancer in formulations, helping create smooth consistency and improve how the product feels or applies.
  • 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 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • 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 A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII 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 4MM76N4WMY
    A synthetic glass-like mineral compound containing calcium, sodium, and boron. Used as a colorant, opacifying agent, and filler in medicines to provide white color, improve appearance, and add bulk to tablets or capsules.
  • UNII 9S60Q72309
    A plant-derived ingredient made from safflower seed components. It acts as an emulsifier and carrier to help distribute oils and active ingredients evenly throughout the medicine.
  • UNII GSA2TXZ34G
    A synthetic polymer made from castor oil and a chemical linker, used as a coating or binder in medications to control how and when the active ingredient is released in the body.
  • UNII 8D9H4QU99H
    A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
  • UNII 3V5U97P248
    A synthetic organic compound used as a UV filter and stabilizer in medications. It helps protect the drug from light degradation and may improve shelf life in formulations exposed to sunlight.
  • UNII 1F2S8T535O
    A synthetic polymer made from fatty acids and a chemical compound that binds ingredients together. It works as a binder and film-former in solid dosage forms, helping hold tablets together and coat their surface.
  • 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 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 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 86FQE96TZ4
    A synthetic polymer, this ingredient acts as a thickener and suspending agent in liquid formulations. It helps maintain uniform consistency and keeps particles evenly distributed throughout the medicine.
  • UNII 76LN7P7UCU
    Lauryl glucoside is a mild plant-based cleansing agent made from coconut oil and glucose. It's used in medicines as a surfactant to help dissolve and distribute ingredients evenly throughout the formulation.
  • 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 9354SX710I
    Morus nigra leaf is a plant-derived ingredient from the black mulberry tree. It may be used in formulations for its traditional properties or as a natural flavoring or coloring agent.
  • UNII S46HJ3710D
    A plant-derived ingredient from the bayberry shrub, used as a natural binder and thickener to help hold the medicine together and improve its texture and consistency.
  • UNII 6AK28695LF
    A plant-derived surfactant made from myristic acid and glucose. It helps dissolve or suspend other ingredients and improves how the medicine spreads or absorbs in the body.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • 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 Q48X4BL3TV
    A synthetic emulsifier made from plant-derived glycerin and lauric acid. It helps blend oil and water-based ingredients together in creams and lotions for smooth, uniform texture.
  • 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 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 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 7QY1MH15BG
    A synthetic organic compound used as a flavoring agent in medicines. It provides a mild, pleasant taste to mask bitter drug flavors and improve patient acceptance of oral formulations.
  • 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 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 65A9F4P024
    A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
  • UNII 5EHL50I4MY
    A sodium salt compound used as a chelating agent in medicines. It binds to metals and minerals to improve stability, prevent discoloration, and help the medication stay effective longer.
  • 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.

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

The official label also statesWater (Aqua), Carthamus Tinctorius (Safflower) Oleosomes, Glycerin, Butyloctyl Salicylate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Allantoin, Arctostaphylos Uva-Ursi Leaf Extract, Sodium Hyaluronate, Panthenol, Tocopheryl Acetate, Bisabolol, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Morus Nigra Leaf Extract, Myrica Cerifera (Bayberry) Bark Extract, Bis-Dodecylhexadecyl Dimer Dilinoleate/Propanediol Copolymer, Silica, Phenoxyethanol, Lauryl Glucoside, Polyglyceryl-6 Laurate, Aminopropyl Ascorbyl Phosphate, C12-15 Alkyl Benzoate, Calcium Sodium Borosilicate, Ethylhexylglycerin, Diethylhexyl Syringylidenemalonate, Xanthan Gum, Myristyl Glucoside, Raspberry Ketone, Sodium Stearoyl Glutamate, Polyhydroxystearic Acid, Dimethicone, Polyglyceryl-6 Polyricinoleate, Tetrasodium Glutamate Diacetate, Dilinoleic Acid/Butanediol Copolymer, Castor Oil/IPDI Copolymer, Sodium Hydroxide, Propanediol, Butylene Glycol, Iron Oxide (CI 77491)

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

LabelerFace Reality,LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code70707
First marketedNov 2025
Product typeHuman Otc Drug
Portfolio3 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 30 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 87 words ▾

Directions apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating 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: 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

⚠️ Warnings 54 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 a Poison Control Center right away.

🧪 Active Ingredient 12 words ▾

Active Ingredient Octocrylene 9% Homosalate 6% Octisalate 5% Avobenzone 3% Purpose Sunscreen

🧪 Inactive Ingredients 93 words ▾

Inactive ingredients: Water (Aqua), Carthamus Tinctorius (Safflower) Oleosomes, Glycerin, Butyloctyl Salicylate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Allantoin, Arctostaphylos Uva-Ursi Leaf Extract, Sodium Hyaluronate, Panthenol, Tocopheryl Acetate, Bisabolol, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Morus Nigra Leaf Extract, Myrica Cerifera (Bayberry) Bark Extract, Bis-Dodecylhexadecyl Dimer Dilinoleate/Propanediol Copolymer, Silica, Phenoxyethanol, Lauryl Glucoside, Polyglyceryl-6 Laurate, Aminopropyl Ascorbyl Phosphate, C12-15 Alkyl Benzoate, Calcium Sodium Borosilicate, Ethylhexylglycerin, Diethylhexyl Syringylidenemalonate, Xanthan Gum, Myristyl Glucoside, Raspberry Ketone, Sodium Stearoyl Glutamate, Polyhydroxystearic Acid, Dimethicone, Polyglyceryl-6 Polyricinoleate, Tetrasodium Glutamate Diacetate, Dilinoleic Acid/Butanediol Copolymer, Castor Oil/IPDI Copolymer, Sodium Hydroxide, Propanediol, Butylene Glycol, Iron Oxide (CI 77491)

🎯 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 19 words ▾

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

📄 Questions or Comments 4 words ▾

Questions or comments? 1-866-477-3077

📄 Package Label / Principal Display Panel 3 words ▾

Package Labeling: Label

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 OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE — the ingredient across all brands.

Top reported reactions

Fatigue15
Dyspnoea14
Dizziness12
Headache12
Anxiety11
Chronic Kidney Disease11
Constipation11

Reporter sex

230 reports

Serious outcomes

Hospitalization46
Disabling9
Life-threatening7
Death6
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 12 0
Most recent year is provisional (FAERS lags ~3 months).
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 Face Reality,LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Face Reality,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.
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.