JLo Beauty That Big Screen Broad Spectrum SPF 30 Moisturizer Homosalate, Octisalate, and Zinc Oxide 150 mg/mL; 50 mg/mL; 30 mg/mL Cream — NDC 79625-0001-19 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

JLo Beauty That Big Screen Broad Spectrum SPF 30 Moisturizer Homosalate, Octisalate, and Zinc Oxide 150 mg/mL; 50 mg/mL; 30 mg/mL Cream — NDC 79625-001-19 (Billing 79625-0001-19)

by Ascendant Beauty LLC · 1 JAR in 1 BOX / 50 mL in 1 JAR

This is a package of JLo Beauty That Big Screen Broad Spectrum SPF 30 Moisturizer Homosalate, Octisalate, and Zinc Oxide 150 mg/mL; 50 mg/mL; 30 mg/mL Cream from Ascendant Beauty LLC, marketed since Apr 2021 and currently FDA-listed.

NDC 79625-0001-19
🏷️ FDA NDC (as labeled) 79625-001-19 billing pads the product segment with a zero
This package
Contains50 mL in 1 jar Pack sizes2 compare ↓
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 79625-001-19 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
79625 labeler · 001 product · 19 package
Package marketed since
Apr 1, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7962500119 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 79625-001-19
Product NDC 79625-001
11-digit billing NDC 79625000119
UNII V06SV4M95S, 4X49Y0596W, SOI2LOH54Z
Application # M020
SPL Set ID cba4e886-c4c6-4377-8f4c-250aef4b95fb
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-04-01
Route TOPICAL
Dosage form CREAM
Substance HOMOSALATE; OCTISALATE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 79625-001-19 — 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 → 79625-0001-19. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

🧪 What is this product?

This is an over-the-counter topical cream moisturizer that contains three sunscreen active ingredients. Homosalate and octisalate are organic ultraviolet filters commonly used to absorb UV rays, while zinc oxide is a mineral filter that typically reflects UV light. Products of this type are generally formulated to provide broad-spectrum sun protection (covering both UVA and UVB rays) when applied to the skin.

Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 15 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
79625-0001-07 79625-001-07 Main listing 15 mL in 1 JAR 2021-04-01 — Active
79625-0001-19 You're viewing this 1 JAR in 1 BOX / 50 mL in 1 JAR 2021-04-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 jar in 1 box / 50 ml in 1 jar.
What NDC number is used to bill for this package of JLo Beauty That Big Screen Broad Spectrum SPF 30 Moisturizer Homosalate, Octisalate, and Zinc Oxide 150 mg/mL; 50 mg/mL; 30 mg/mL Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
JLo Beauty That Big Screen Broad Spectrum SPF 30 Moisturizer 150 mg/mL; 50 mg/mL; 30 mg/mLthis 79625-0001-19 Ascendant 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

🏛️
2021
On the market since
Apr 2021
📍
2026
Currently FDA-listed
5 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII 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 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 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 5ZA2S6B08X
    Cetyl palmitate is a waxy substance made from natural fats. It works as a binder and thickener to help hold the medicine together and control how it dissolves in your body.
  • UNII UE856F2T78
    A gelling agent derived from red seaweed. It thickens liquid medicines and helps create a smooth texture, often used in syrups and suspensions to improve how the medicine coats the mouth and throat.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • UNII 5B8915UELW
    A plant-derived compound used as an antioxidant in medicines. It helps prevent spoilage and degradation of active ingredients during storage by protecting them from oxidative damage.
  • 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 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 W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • 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 21RND18XRR
    A seaweed extract 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 Y9H1V576FH
    Honey is a natural sweetener made by bees from flower nectar. In medicines, it adds sweetness to improve taste and may help soothe throat irritation in lozenges or syrups.
  • 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 4PW41QCO2M
    Indian frankincense is a natural resin extracted from trees native to India. It is used in medicines as a binder and thickening agent to help hold ingredients together and improve texture.
  • UNII 19NOL5474Q
    Isopentyldiol is a synthetic alcohol derived from isoprene. It functions as a humectant and solvent in formulations, helping to retain moisture and dissolve or suspend active ingredients.
  • 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 6T087FC66H
    A red seaweed extract used as a thickener and gelling agent in liquid and semi-solid formulations. It helps create consistent texture and improve how the medicine feels or flows.
  • 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 61W322NLDV
    A plant extract from sacred lotus flowers. Used as a natural colorant, fragrance, or skin-conditioning agent in topical formulations.
  • UNII 6Q6H1PKC05
    A synthetic peptide derived from palmitic acid and amino acids. It functions as a skin-conditioning agent and emollient in topical formulations, helping to soften and smooth the product texture while supporting ingredient stability.
  • 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 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 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 NVZ4I0H58X
    A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation 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 B8WCK70T7I
    Trehalose is a natural sugar made from two glucose molecules linked together. It's used in medicines as a filler to add bulk, a sweetener for taste, and a stabilizer to help keep active ingredients effective during storage.
  • UNII LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII V038D626IF
    A plant extract from Withania somnifera root, traditionally used in herbal preparations. It may function as an active botanical ingredient or filler in formulations, though its primary role depends on the specific product formulation.
  • 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.

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

The official label also statesWater, Glycerin, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Hydrolyzed Vegetable Protein, Nelumbo Nucifera Flower Extract, Withania Somnifera Root Extract, Himanthalia Elongata Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Gigartina Stellata Extract, Hydrogenated Lecithin, Chondrus Crispus Extract, Camellia Sinensis Leaf Extract, Aspalathus Linearis Extract, Boswellia Serrata Extract, Honey Extract, Tocopheryl Acetate, Tocopherol, Ethyl Ferulate Trehalose, Disodium EDTA, Cetyl Palmitate, Bisabolol, Triethoxycaprylylsilane, Sorbitan Stearate, Polysorbate 80, Butylene Glycol, Sodium Hyaluronate, Isopentyldiol, Palmitoyl Tetrapeptide-10, Farnesol, Tetrapeptide-14, Caprylyl Glycol, Hexylene Glycol, Ethylhexylglycerin, Xanthan Gum, Citric Acid, Phenoxyethanol, Sodium Benzoate.

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

LabelerAscendant Beauty LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code79625
First marketedApr 2021
Product typeHuman Otc Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 4 words ▾

Use Helps prevent sunburn.

⏱️ Dosage and Administration 90 words ▾

Directions Apply a generous amount. Use daily in the morning. At least 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, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit in the sun, especially from 10 a.am. to 2 p.m.

Wear long0sleeved shirts, pants, hats and sunglasses.

⚠️ Warnings 56 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 product is swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 11 words ▾

Other information Protect this product from excessive heat and direct sun.

🧪 Active Ingredient 23 words ▾

Active ingredient Homosalate - 15.0% Octisalate – 5.0% Zinc – 3.0%

Active Ingredients Homosalate – 15.0%, Octisalate - 5.0%, Zinc Oxide - 3.0%

🧪 Inactive Ingredients 89 words ▾

Inactive Ingredients Water, Glycerin, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Hydrolyzed Vegetable Protein, Nelumbo Nucifera Flower Extract, Withania Somnifera Root Extract, Himanthalia Elongata Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Gigartina Stellata Extract, Hydrogenated Lecithin, Chondrus Crispus Extract, Camellia Sinensis Leaf Extract, Aspalathus Linearis Extract, Boswellia Serrata Extract, Honey Extract, Tocopheryl Acetate, Tocopherol, Ethyl Ferulate Trehalose, Disodium EDTA, Cetyl Palmitate, Bisabolol, Triethoxycaprylylsilane, Sorbitan Stearate, Polysorbate 80, Butylene Glycol, Sodium Hyaluronate, Isopentyldiol, Palmitoyl Tetrapeptide-10, Farnesol, Tetrapeptide-14, Caprylyl Glycol, Hexylene Glycol, Ethylhexylglycerin, Xanthan Gum, Citric Acid, Phenoxyethanol, Sodium Benzoate.

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 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 21 words ▾

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

📄 Questions or Comments 8 words ▾

Questions or comments? Visit JLoBeauty.com or toll-free 1-800-557-8164

📄 Package Label / Principal Display Panel 46 words ▾

PRINCIPAL DISPLAY PANEL - 50 mL Jar Box JLO BEAUTY™ THAT BIG SCREEN IN A BROAD SPECTRUM SPF 30 MOISTURIZER Hydrate. Protect. Soothe. FIGHTS FREE RADICALS, UVA/UVB, INFRARED + BLUE LIGHT. 30+ SPF 1.7 fl. oz (50 mL) Principal Display Panel - 50 mL Jar Box

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 Homosalate, Octisalate, and Zinc Oxide — the ingredient across all brands.

Top reported reactions

Dermatitis Contact2
Acne Cystic1
Application Site Erythema1
Application Site Warmth1
Basal Cell Carcinoma1
Dermatitis Acneiform1
Dry Skin1

Reporter sex

8 reports
Female · 100%

Serious outcomes

Hospitalization1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 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 Ascendant Beauty LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 15 ml (79625-0001-07). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Ascendant Beauty 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.