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Royal Defy Multi-Performance Age Protector Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene 3 g/100mL; 10 g/100mL; 5 g/100mL; 10 g/100mL Lotion, 50 mL — NDC 68828-0764-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Royal Defy Multi-Performance Age Protector Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene 3 g/100mL; 10 g/100mL; 5 g/100mL; 10 g/100mL Lotion, 50 mL — NDC 68828-764-01 (Billing 68828-0764-01)

by Distribuidora Comercial Jafra, S.A. de C.V. · 50 mL in 1 CARTON

This is a package of 50 mL of Royal Defy Multi-Performance Age Protector Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene 3 g/100mL; 10 g/100mL; 5 g/100mL; 10 g/100mL Lotion from Distribuidora Comercial Jafra, S.A. de C.V., marketed since Jan 2022 and currently FDA-listed. It is this product's only package size.

NDC 68828-0764-01
🏷️ FDA NDC (as labeled) 68828-764-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 68828-764-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68828 labeler · 764 product · 01 package
Package marketed since
Jan 12, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6882876401 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68828-764-01
Product NDC 68828-764
11-digit billing NDC 68828076401
UNII G63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM
Application # M020
SPL Set ID c3b265b1-ab84-4ea9-b283-c92f5a4cf461
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-01-12
Route TOPICAL
Dosage form LOTION
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 68828-764-01 — 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 → 68828-0764-01. 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?

Royal Defy Multi-Performance Age Protector is a topical lotion sunscreen marketed as an over-the-counter monograph product. It contains four ultraviolet (UV) filters: avobenzone, homosalate, octisalate, and octocrylene. These ingredients are typically used together to absorb and scatter both UVA and UVB radiation from sunlight. This broad-spectrum lotion is formulated to provide sun protection when applied to exposed skin.

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
68828-0764-01 You're viewing this Main listing 50 mL in 1 CARTON 2022-01-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Royal Defy Multi-Performance Age Protector Broad Spectrum SPF 50 3 g/100mL; 10 g/100mL; 5 g/100mL; 10 g/100mLthis 68828-0764-01 Distribuidora 50 ml — — FDA listed —
Premium Moisturizing Sunscreen Broad Spectrum SPF 50 3 g/100mL; 10 g/100mL; 5 g/100mL; 10 g/100mL 44717-0069-01 Wasatch 177 ml — — FDA listed —
Tender Moments Baby Sunscreen Broad Spectrum SPF 50 Water Resistant (40 minutes) 3 g/100mL; 10 g/100mL; 5 g/100mL; 10 g/100mL 68828-0444-01 Distribuidora 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

🏛️
2022
On the market since
Jan 2022
📍
2026
Currently FDA-listed
4 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 LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII 6VNO72PFC1
    A natural oil extracted from avocado fruit. It's used in medicines as an emollient and carrier to help dissolve or deliver active ingredients and improve how the product feels on skin or mucous membranes.
  • UNII WAO5MNK9TU
    Benzyl salicylate is a fragrant chemical compound used as a flavor and scent ingredient in medicines. It helps mask unpleasant tastes or odors in liquid or oral formulations.
  • 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 T7540GJV69
    A synthetic fragrance compound used as a flavor or scent ingredient in medicines. It helps mask unpleasant tastes or odors in the formulation to make the medication more palatable.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII 4370DF050B
    Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
  • UNII 619G5K328Y
    A yellow-to-reddish powder form of cerium, a rare earth element. Used as a polishing agent and anti-caking ingredient to keep powders free-flowing and prevent clumping in solid dosage forms.
  • UNII D9108TZ9KG
    Cocoa is a natural powder made from roasted cacao beans. It's used as a flavoring and coloring agent to make medicines taste better and appear brown.
  • UNII E107L85C40
    Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII S3KFG6Q5X8
    An organic chemical compound used as a UV filter in topical formulations. It helps protect the medicine or product from degradation caused by sunlight exposure during storage and use.
  • 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 EB41QIU6JL
    Farnesol is a natural fragrant compound found in plants. It's used in medicines as a preservative and flavoring agent to improve taste and help prevent microbial growth.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during 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 H1109Z9J4N
    A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
  • UNII 8SQ0VA4YUR
    A fragrance compound derived from natural sources, used to add pleasant scent to the medicine. It serves as a flavoring or aromatic agent to mask unpleasant tastes or improve the product's sensory appeal.
  • 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 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII GFD7C86Q1W
    A natural oil extracted from citrus peels, (+)-limonene is used as a flavoring agent and solvent in medicines. It helps dissolve active ingredients and provides a lemon or orange taste.
  • UNII D81QY6I88E
    Linalool is a natural fragrant oil found in plants like lavender and citrus. It's used in medicines as a flavoring agent and to mask unpleasant tastes or smells.
  • 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 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 6UYK2W1W1E
    A natural oil extracted from olives. It acts as an emollient and lubricant in formulations, helping to soften ingredients and improve how the medicine spreads or flows.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • 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 ML9LGA7468
    A naturally-derived alcohol used as a preservative and fragrance in medicines. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII Z47NNT4J11
    A synthetic plastic polymer used as a film-coating material on tablets and capsules. It helps protect the medicine, control how fast it dissolves, and improve appearance by creating a smooth, glossy outer layer.
  • UNII T9296U138P
    A synthetic polymer derived from polyester chemistry, modified with a cyanodiphenylpropenoyl cap. It serves as a film-former and binder in pharmaceutical formulations, helping create protective coatings on tablets or improving product consistency.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • 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 L497I37F0C
    Royal jelly is a creamy, nutrient-rich secretion produced by honeybees. In medications, it serves as a natural sweetener, flavor enhancer, and ingredient that may improve taste and palatability of oral formulations.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 469OTG57A2
    Sodium pyrrolidone carboxylate is a synthetic polymer derived from pyrrolidone chemistry. It functions as a solubilizer and binder in medications, helping dissolve poorly water-soluble drugs and hold tablet ingredients together.
  • UNII L7HT8F1ZOD
    A plant-based oil extracted from soybeans. It's used as an emulsifier and lubricant to help mix ingredients evenly and prevent sticking during tablet or capsule manufacturing.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII 5Z4DPO246A
    A synthetic plastic polymer made from styrene and acrylamide monomers. It acts as a film-former and binder in tablets and capsules, helping hold ingredients together and control how quickly the medicine dissolves and releases in your body.
  • UNII 274KW0O50M
    Sucrose stearate is a compound made from sugar and stearic acid (a fatty substance). It works as an emulsifier and surfactant to help mix oils and water-based ingredients together in the medicine.
  • 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 035MV9S1C3
    A plastic-like polymer made from two chemical compounds joined together. It acts as a binder and film-former in tablets and capsules, helping hold ingredients together and create a protective coating on the medicine's surface.
  • 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.

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

The official label also statesWater, Butyloctyl Salicylate, VP/Eicosene Copolymer, Polyester-8, Glyceryl Stearate,PEG-100 Stearate, Styrene/Acrylates Copolymer, Ethylhexyl Methoxycrylene,Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sucrose Stearate,Squalane, Phenoxyethanol, Caprylyl Glycol, Xanthan Gum, Polymethyl Methacrylate,Polysorbate 60, Potassium Sorbate, Royal Jelly Powder, Tocopheryl Acetate, Hexylene Glycol, Persea Gratissima (Avocado) Oil, Sodium PCA, Caprylic/Capric Triglyceride,Phytosterols, Cerium Oxide, Glycerin, Olea Europaea (Olive) Fruit Oil, Glycine Soja(Soybean) Seed Extract, Butyrospermum Parkii (Shea) Butter, Royal Jelly, Dipropylene Glycol, Lecithin, Alumina, Sodium Hyaluronate, Hydrogenated Lecithin, Butylene Glycol, Tocopherol, Phenethyl Alcohol, Tuber Magnatum Extract, Ceramide NP, Ethylhexylglycerin, Maltodextrin, Theobroma Cacao (Cocoa) Seed Extract, Tetrapeptide-45, Sodium Benzoate, Farnesol, Fragrance/Parfum, Benzyl Salicylate, Butylphenyl Methylpropional, Linalool, Hydroxycitronellal, Limonene

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

LabelerDistribuidora Comercial Jafra, S.A. de C.V.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code68828
First marketedJan 2022
Product typeHuman Otc Drug
Portfolio75 products on file

More NDCs from Distribuidora Comercial Jafra, S.A. de C.V. labeler code 68828

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 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 93 words ▾

Directions apply liberally and evenly 15 minutes before sun exposure reapply at least every 2 hours. use a water-resistant sunscreen if swimming or sweating children under 6 months : Ask a doctor 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 value 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

⚠️ Warnings 35 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

🧪 Active Ingredient 10 words ▾

Active Ingredients Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 10%

🧪 Inactive Ingredients 101 words ▾

Inactive ingredients Water, Butyloctyl Salicylate, VP/Eicosene Copolymer, Polyester-8, Glyceryl Stearate,PEG-100 Stearate, Styrene/Acrylates Copolymer, Ethylhexyl Methoxycrylene,Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sucrose Stearate,Squalane, Phenoxyethanol, Caprylyl Glycol, Xanthan Gum, Polymethyl Methacrylate,Polysorbate 60, Potassium Sorbate, Royal Jelly Powder, Tocopheryl Acetate, Hexylene Glycol, Persea Gratissima (Avocado) Oil, Sodium PCA, Caprylic/Capric Triglyceride,Phytosterols, Cerium Oxide, Glycerin, Olea Europaea (Olive) Fruit Oil, Glycine Soja(Soybean) Seed Extract, Butyrospermum Parkii (Shea) Butter, Royal Jelly, Dipropylene Glycol, Lecithin, Alumina, Sodium Hyaluronate, Hydrogenated Lecithin, Butylene Glycol, Tocopherol, Phenethyl Alcohol, Tuber Magnatum Extract, Ceramide NP, Ethylhexylglycerin, Maltodextrin, Theobroma Cacao (Cocoa) Seed Extract, Tetrapeptide-45, Sodium Benzoate, Farnesol, Fragrance/Parfum, Benzyl Salicylate, Butylphenyl Methylpropional, Linalool, Hydroxycitronellal, Limonene

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 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.

📄 Package Label / Principal Display Panel 8 words ▾

Product label image description image description image description

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 Royal Defy Multi-Performance Age Protector Broad Spectrum SPF 50 (this brand).

Top reported reactions

Acute Myeloid Leukaemia2
Exposure To Toxic Agent2
Product Contamination Chemical2
Rash2
Anaphylactic Reaction1
Application Site Erythema1
Application Site Exfoliation1

Age at onset

Adolescent2
Adult1

Reporter sex

0 reports

Serious outcomes

Life-threatening1
Death1
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 2 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 Distribuidora Comercial Jafra, S.A. de C.V.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Distribuidora Comercial Jafra, S.A. de C.V. 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.
← 68828-0762-01 · Distribuidora 68828-0800-01 · Distribuidora →
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.