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Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENE 3 g/100mL; 7 g/100mL; 5 g/100mL; 10 g/100mL Cream — NDC 68828-0643-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENE 3 g/100mL; 7 g/100mL; 5 g/100mL; 10 g/100mL Cream — NDC 68828-643-01 (Billing 68828-0643-01)

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

This is a package of Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENE 3 g/100mL; 7 g/100mL; 5 g/100mL; 10 g/100mL Cream from Distribuidora Comercial Jafra, S.A. de C.V., marketed since Jan 2026 and currently FDA-listed. It is this product's only package size.

NDC 68828-0643-01
🏷️ FDA NDC (as labeled) 68828-643-01 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 68828-643-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68828 labeler · 643 product · 01 package
Package marketed since
Jan 1, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6882864301 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68828-643-01
Product NDC 68828-643
11-digit billing NDC 68828064301
UNII G63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM
Application # M020
SPL Set ID 03b0f2ee-526b-4513-b70a-2918ad322b5e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-01
Route TOPICAL
Dosage form CREAM
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 68828-643-01 — 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 → 68828-0643-01. 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?

Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 Sunscreen is a topical cream that combines sunscreen active ingredients with a moisturizer base. Avobenzone, homosalate, octisalate, and octocrylene are ultraviolet (UV) light filters typically used together in sunscreen products to help protect skin from sun exposure. This is an over-the-counter monograph drug, meaning it is made according to FDA category rules for sunscreen products 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
68828-0643-01 You're viewing this Main listing 1 JAR in 1 CARTON / 50 mL in 1 JAR 2026-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 Sunscreen 3 g/100mL; 7 g/100mL; 5 g/100mL; 10 g/100mLthis 68828-0643-01 Distribuidora 1 jar — — 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

🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 P01OUT964K
    A fragrant plant-derived alcohol used as a flavoring agent and fragrance component in medicines. It provides taste and aroma to make the product more pleasant to use.
  • UNII 8Z5ZAL5H3V
    A synthetic polymer made from acrylate compounds. It acts as a thickener and stabilizer in topical formulations, helping create the right texture and prevent separation of ingredients.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 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 I9PJ0O6294
    A modified starch derived from corn or potato starch with aluminum salt and octenylsuccinic acid added. It acts as a binder to hold tablet ingredients together and as a thickening agent in liquid formulations.
  • UNII LU49E6626Q
    A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
  • UNII 9XRL057X90
    A plant-derived gum that acts as a thickener and binder in medicines. It helps create the right texture and holds ingredients together in tablets, capsules, or liquids.
  • UNII 6L246LAM9T
    A synthetic oil derived from glycerol and adipic acid. It acts as an emulsifier and solubilizer in medicines, helping mix ingredients that don't naturally blend together and improving how the body absorbs the active drug.
  • UNII UQ7SPY0IRF
    A lightweight mineral oil derived from petroleum, used as a solvent and emollient to help dissolve active ingredients and improve the product's texture and spreadability in topical formulations.
  • 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 C04977SRJ5
    Ceramide NG is a naturally occurring lipid compound that helps form protective barriers in skin and cosmetic formulations. It functions as an emollient and skin-conditioning agent, helping products retain moisture and maintain smooth texture.
  • UNII 921FTA1500
    A synthetic compound derived from cetyl alcohol and ethylene oxide. It acts as an emulsifier and solubilizer to help blend oil and water components together in liquid formulations.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • 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 2V6E5WN99N
    A lipid compound made from fatty acids, used as an emulsifier and stabilizer in medicines to help mix oil and water-based ingredients and keep them from separating.
  • UNII 420IP921MB
    A chelating agent derived from edetic acid that binds to metals in the formulation. It helps stabilize the medicine by preventing metal ions from causing breakdown or discoloration.
  • 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 US2H3D7800
    Garcinia indica seed butter is a natural fat extracted from the seeds of the kokum tree. It's used in medicines as a binder and lubricant to help hold ingredients together and improve how the tablet or capsule flows during manufacturing.
  • 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 2788Z9758H
    A plant extract from licorice root used as a sweetener, flavoring agent, and natural emulsifier in medicines. It helps improve taste and may aid in keeping ingredients evenly mixed throughout the product.
  • UNII 79Y1949PYO
    Gold is a precious metal used in some medications as an active therapeutic ingredient rather than a typical inactive filler. It may be included in certain formulations for its purported anti-inflammatory or immunomodulatory properties in specific medical treatments.
  • 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 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 YK3DC63Y5M
    A mineral compound derived from natural or synthetic sources that acts as an anti-caking agent and flow aid. It helps prevent clumping and improves the powder's ability to flow smoothly during manufacturing and tablet formation.
  • UNII 4042ZC00DY
    A waxy ester derived from myristic acid, used as an emollient and lubricant in topical formulations. It helps soften skin contact, reduce friction during application, and improve the texture and spreadability of creams and ointments.
  • UNII HO4ZT5S86C
    A synthetic peptide derived from amino acids, used as a skin-conditioning agent and emollient in topical formulations to help soften and smooth the skin surface.
  • 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 KU94FIY6JB
    A natural enzyme extract from papaya fruit that helps break down proteins. It's used in some medicines as a digestive aid ingredient and may help tablets dissolve or break apart in the stomach.
  • UNII 258O76T85M
    A plant-derived oil component combined with polyethylene glycol (PEG), a synthetic polymer. It works as an emulsifier to help mix oil and water-based ingredients, and as a solubilizer to keep active drugs dissolved in the formulation.
  • 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 ZEL54N6W95
    A silicone-based compound that helps oils and water mix together. Used in medicines as an emulsifier and anti-foaming agent to improve texture and prevent bubbles in liquids and creams.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • 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 YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 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 71B37NR06D
    Soy isoflavones are natural plant compounds extracted from soybeans. They are used in dietary supplements and some medications as an active botanical ingredient to support formulation claims, though they function as an additive rather than a traditional inactive excipient.
  • UNII 2MT5XMR2YW
    A plant-derived material from Spanish chestnut trees, used as a filler and binder in tablets and capsules to add bulk and help hold the medicine together.
  • UNII KM7N50LOS6
    Tin oxide is an inorganic mineral compound used in medicines as a colorant and opacifying agent. It provides white or off-white color to tablets, capsules, and coatings while helping make formulations less transparent.
  • UNII 5WX2EGD0DK
    Stearyl stearate is a waxy ester made from stearic acid. It acts as a lubricant and binder in tablets and capsules to help them hold together and slide smoothly through manufacturing equipment.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 8OC9U7TQZ0
    Tribehenin is a waxy, plant-derived substance that acts as a lubricant and glidant in tablets and capsules. It helps the medicine flow smoothly during manufacturing and prevents sticking during production and packaging.
  • 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.

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

The official label also statesWater, Stearyl Stearate, Glycerin, Cetearyl Alcohol, Myristyl Myristate, C10-11 Isoalkane, Garcinia Indica Seed Butter, Sodium PCA, Pentylene Glycol, Cetyl Alcohol, Bis-Diglyceryl Polyacyladipate-2, Ceteareth-20, PEG-12 Dimethicone, Butyrospermum Parkii (Shea) Butter, Carica Papaya (Papaya) Fruit Extract, Phenoxyethanol, Glyceryl Stearate, PEG-100 Stearate, Aluminum Starch Octenylsuccinate, Fragrance, Ceteth-20 Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, C12-15 Alkyl Benzoate, Panthenol, Biosaccharide Gum-4, Glycyrrhiza Glabra (Licorice) Root Extract, Caprylyl Glycol, Aminomethyl Propanol, Tocopheryl Acetate, Dicetyl Phosphate, Castanea Sativa (Chestnut) Seed Extract, Ethylhexylglycerin, Hexylene Glycol, Trisodium EDTA, Smithsonite Extract, Tribehenin, Linalool, Alcohol, Polysorbate 80, Ceramide NG, Citronellol, Lecithin, Limonene, PEG-10 Rapeseed Sterol, Soy Isoflavones, Palmitoyl Hexapeptide-12, Synthetic Fluorphlogopite, Titanium Dioxide/CI 77891, Iron Oxide/CI 77491, Tin Oxide, Gold

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 2026
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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 32 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 102 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 of age: 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 55 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 10 words ▾

Active ingredients Avobenzone 3% Homosalate 7% Octisalate 5% Octocrylene 10%

🧪 Inactive Ingredients 110 words ▾

Inactive ingredients Water, Stearyl Stearate, Glycerin, Cetearyl Alcohol, Myristyl Myristate, C10-11 Isoalkane, Garcinia Indica Seed Butter, Sodium PCA, Pentylene Glycol, Cetyl Alcohol, Bis-Diglyceryl Polyacyladipate-2, Ceteareth-20, PEG-12 Dimethicone, Butyrospermum Parkii (Shea) Butter, Carica Papaya (Papaya) Fruit Extract, Phenoxyethanol, Glyceryl Stearate, PEG-100 Stearate, Aluminum Starch Octenylsuccinate, Fragrance, Ceteth-20 Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, C12-15 Alkyl Benzoate, Panthenol, Biosaccharide Gum-4, Glycyrrhiza Glabra (Licorice) Root Extract, Caprylyl Glycol, Aminomethyl Propanol, Tocopheryl Acetate, Dicetyl Phosphate, Castanea Sativa (Chestnut) Seed Extract, Ethylhexylglycerin, Hexylene Glycol, Trisodium EDTA, Smithsonite Extract, Tribehenin, Linalool, Alcohol, Polysorbate 80, Ceramide NG, Citronellol, Lecithin, Limonene, PEG-10 Rapeseed Sterol, Soy Isoflavones, Palmitoyl Hexapeptide-12, Synthetic Fluorphlogopite, Titanium Dioxide/CI 77891, Iron Oxide/CI 77491, Tin Oxide, Gold

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Package Label / Principal Display Panel 4 words ▾

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

Top reported reactions

Rash40
Skin Cancer38
Pruritus31
Erythema26
Pain26
Dyspnoea25
Fatigue25

Reporter sex

648 reports

Serious outcomes

Disabling23
Death22
Life-threatening11
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 159 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.
← 68828-0603-01 · Distribuidora 68828-0700-01 · 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.