Revlon Colorstay Light Cover Foundation Homosalate, Octisalate, Octocrylene, Titanium Dioxide,Zinc Oxide 6.97 mg/mL; 4.99 mg/mL; 6 mg/mL; 3 mg/mL; 2.4 mg/mL Emulsion, 1 mL — NDC 10967-663-01 (Billing 10967-0663-01)
by Revlon · 1 mL in 1 TUBE
This is a package of 1 mL of Revlon Colorstay Light Cover Foundation Homosalate, Octisalate, Octocrylene, Titanium Dioxide,Zinc Oxide 6.97 mg/mL; 4.99 mg/mL; 6 mg/mL; 3 mg/mL; 2.4 mg/mL Emulsion from Revlon, marketed since Oct 2020 and currently FDA-listed. It is this product's only package size.
NDC 10967-0663-01
🏷️ FDA NDC (as labeled)
10967-663-01
billing pads the product segment with a zero
🗂️ 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 10967-663-01 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 10967 labeler · 663 product · 01 package
- Package marketed since
- Oct 1, 2020
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 1096766301 0
- FDA record last changed
- Aug 27, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
10967-663-01
Product NDC
10967-663
11-digit billing NDC
10967066301
UNII
15FIX9V2JP, SOI2LOH54Z, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM
Application #
M020
SPL Set ID
b0006b5f-0d56-0efb-e053-2a95a90a5979
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2020-10-01
Route
TOPICAL
Dosage form
EMULSION
Substance
TITANIUM DIOXIDE; ZINC OXIDE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Why two NDCs?
The FDA registers this code as 10967-663-01 — 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 → 10967-0663-01. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
🧪 What is this product?
Revlon Colorstay Light Cover Foundation is a topical emulsion marketed as an over-the-counter cosmetic product under FDA's sunscreen monograph rules. It contains five active ingredients that work together to protect skin from ultraviolet (UV) rays: homosalate, octisalate, and octocrylene function as chemical UV filters, while titanium dioxide and zinc oxide serve as physical UV blockers. This type of product is typically used as a foundation with sun protection applied to the face and exposed skin.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
💬 Questions about Homosalate, Octisalate, Octocrylene, Titanium Dioxide,Zinc Oxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 6, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 10967-0663-01 You're viewing this Main listing | 1 mL in 1 TUBE | 2020-10-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Revlon Colorstay Light Cover Foundation 6.97 mg/mL; 4.99 mg/mL; 6 mg/mL; 3 mg/mL; 2.4 mg/mLthis 10967-0663-01 | Revlon | 1 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2020
On the market since
Oct 2020
📍
2026
Currently FDA-listed
6 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.
- FDA Orange Book · refreshed Oct 3, 2026
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 TR046Y3K1G
A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
-
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 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 3G6A5W338E
Caffeine is a natural stimulant compound commonly extracted from coffee beans and tea leaves. In medicines, it serves as an active booster in pain relievers and cold products to enhance alertness and improve the effectiveness of other ingredients.
-
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 0THT5PCI0R
A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
-
UNII RO266O364U
Dimethicone is a silicone-based lubricant and anti-foaming agent. It reduces friction between particles and prevents foam formation in liquid or semi-solid medicines, helping with smooth mixing and texture.
-
UNII MCU2324216
A silicone-based oil that reduces foaming and helps ingredients mix evenly. It's used as an antifoaming agent and lubricant in tablets, capsules, and liquid formulations.
-
UNII H895X08VNQ
A silicone-based polymer that forms small, hard particles. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and capsules.
-
UNII 9E4CO0W6C5
A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
-
UNII M2HW98ZA4V
Dimethiconol is a silicone-based lubricant and anti-foaming agent. It reduces friction between particles and prevents excess air bubbles in liquid or semi-solid medicines, helping them mix smoothly and stay stable.
-
UNII X687XDK09L
A clay mineral processed to carry positive charges, used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed throughout the product.
-
UNII MP1J8420LU
A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
-
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 4QGR4P2YOI
A silicone-based lubricant that reduces friction between tablet particles and manufacturing equipment. It helps tablets flow smoothly during production and prevents them from sticking together or to machinery.
-
UNII 1K92T9919H
A synthetic surfactant derived from cetyl alcohol and ethylene oxide. It helps dissolve and mix oils with water in formulations, acting as an emulsifier and solubilizer to create uniform medicines.
-
UNII A8289P68Y2
Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
-
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 ML30MJ2U7I
A mineral salt form of magnesium and sulfate. It serves as a filler to add bulk to the tablet or capsule and may help the medicine dissolve or disintegrate properly in the body.
-
UNII 6777U11MKT
A silicone-based lubricant and anti-foaming agent used to reduce surface tension and prevent foam formation during manufacturing and storage of the medication.
-
UNII 196OC77688
A synthetic plastic polymer used as a film-coating material on tablets and capsules. It helps protect the medication, control how fast it dissolves, and improve appearance.
-
UNII V8A1AW0880
Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
-
UNII 25X51I8RD4
Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
-
UNII 8PR7V1SVM0
A silicone-based lubricant combined with polyethylene glycol. It reduces friction and helps the medicine flow smoothly during manufacturing and improves how the product feels when applied or swallowed.
-
UNII 9H0AO7T794
A silicone-based lubricant mixed with polyethylene glycol and polypropylene glycol polymers. It reduces friction between pill surfaces and equipment during manufacturing, and helps the finished product slide smoothly when swallowed.
-
UNII DR0K5NOJ4R
Phenyl trimethicone is a silicone-based lubricant and glidant. It helps powder particles flow smoothly and reduces friction during tablet or capsule manufacturing and filling.
-
UNII 46P231IQV8
A synthetic emulsifier derived from glycerin and fatty acids. It helps blend oil and water-based ingredients together in cosmetic and pharmaceutical formulations to create stable, uniform products.
-
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 8D08K3S51E
Propylene carbonate is a clear liquid solvent derived from propylene. It helps dissolve or suspend active ingredients in liquid medicines and can improve how well the product flows and mixes.
-
UNII 0UI45XV0T6
A plant oil extracted from pomegranate seeds. It's used in formulations as an emollient to soften and smooth the product texture, and sometimes as a carrier or conditioning agent in topical preparations.
-
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 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 5041RX63GN
A synthetic silicon-based polymer used as a glidant and anti-caking agent. It helps powder particles flow smoothly and prevents clumping during manufacturing and storage.
-
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.
35 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesIsododecane, Aqua/Water/Eau, Trimethylsiloxysilicate, Titanium Dioxide, Homosalate, Zinc Oxide [nano], Dimethicone, Cyclopentasiloxane, Glycerin, Propanediol, Ethylhexyl Salicylate, PEG-10 Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Octocrylene, Niacinamide, PEG/PPG-18/18 Dimethicone, Alumina, Methyl Methacrylate Crosspolymer, Punica Granatum Sterols, Phenyl Trimethicone, 1,2-Hexanediol, Alcohol Denat., Caffeine, Caprylyl Glycol, Dimethicone Crosspolymer, Dimethiconol, Disteardimonium Hectorite, Hydrogen Dimethicone, Isoceteth-10, Lecithin, Magnesium Sulfate, Methicone, Mica, Polyglyceryl-3 Diisostearate, Polysilicone-11, Propylene Carbonate, Silica, Silica silylate, Tetrasodium EDTA, Tocopheryl Acetate, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Titanium Dioxide (CI 77891).
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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerRevlon
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code10967
First marketedOct 2020
Product typeHuman Otc Drug
Portfolio18 products on file
More NDCs from Revlon labeler code 10967
- Mitchum Clear Gel ALUMINUM SESQUICHLOROHYDRATE .25 g/mL Liquid NDC 10967-647-34
- Mitchum Clear Gel ALUMINUM SESQUICHLOROHYDRATE .25 g/mL Liquid NDC 10967-648-34
- Mitchum Advance Control Pure Fresh Aluminum Chlorohydrate .25 g/mL Aerosol NDC 10967-649-04
- American Crew Pyrithione Zinc 1 mg/mL Shampoo NDC 10967-650-25
- American Crew All In One Face Balm Broad Spectrum SPF 15 Octisalate,Homosalate,Avobenzone,Octocrylene 5 mg/mL; 5 mg/mL; 2 mg/mL; 2 mg/mL Liquid NDC 10967-651-24
- Revlon Colorstay Preo and Protect Primer Titanium Dioxide, Zinc Oxide, Octinoxate 9 mg/mL; 7.5 mg/mL; 3.6 mg/mL Liquid NDC 10967-652-11
- Elizabeth Arden, Great 8, Moisturizer SPF 35 Avobenzone, Octisalate, Homosalate 3 mg/mL; 10 mg/mL; 5 mg/mL Emulsion NDC 10967-665-15
- CERAMIDE LIFT and FIRM Octinoxate, Oxybenzone, Avobenzone, Octisalate, Octocrylene 5 mg/g; 5 mg/g; 7.5 mg/g; 2.2 mg/g Emulsion NDC 10967-666-17
- CERAMIDE LIFT and FIRM EYE SPF 15 Oxybenzone, Octinoxate 4.1 mg/g; 1.4 mg/g Emulsion NDC 10967-667-61
- Ceramide Makeup Spf 15 Octinoxate, Titanium Dioxide 3 mg/g; 4 mg/g Cream NDC 10967-668-01
- CERAMIDE PREMIERE BROAD SPECTRUM SPF 30 Octinoxate, Octisalate, Oxybenzone, Octocrylene, Avobenzone 4 mg/g; 7.5 mg/g; 3 mg/g; 2 mg/g; 5 mg/g Emulsion NDC 10967-669-17
- Prevage City Smart Titanium Dioxide, Zinc Oxide 5.6 mg/g; 6.2 mg/g Emulsion NDC 10967-670-62
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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 and Cautions
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📄 Keep Out of Reach of Children
📖 Instructions for Use
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Helps prevent sunburn
⏱️ Dosage and Administration ▾
As Needed
⚠️ Warnings and Cautions ▾
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 10am-2pm, wear long-sleeved shirts, pants, hats and sunglasses.
⚠️ Warnings ▾
Warnings For external use only. Do not use on damaged or broken skin When using this product keep out of the eyes. Rinse with water to remove. Stop use and ask doctor is rash occurs.
🧪 Active Ingredient ▾
Active Ingredients Homosalate 6.00% Octisalate 3.00% Octocrylene 2.40% Titanium Dioxide 6.97% Zinc Oxide 4.99%
🧪 Inactive Ingredients ▾
Isododecane, Aqua/Water/Eau, Trimethylsiloxysilicate, Titanium Dioxide, Homosalate, Zinc Oxide [nano], Dimethicone, Cyclopentasiloxane, Glycerin, Propanediol, Ethylhexyl Salicylate, PEG-10 Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Octocrylene, Niacinamide, PEG/PPG-18/18 Dimethicone, Alumina, Methyl Methacrylate Crosspolymer, Punica Granatum Sterols, Phenyl Trimethicone, 1,2-Hexanediol, Alcohol Denat., Caffeine, Caprylyl Glycol, Dimethicone Crosspolymer, Dimethiconol, Disteardimonium Hectorite, Hydrogen Dimethicone, Isoceteth-10, Lecithin, Magnesium Sulfate, Methicone, Mica, Polyglyceryl-3 Diisostearate, Polysilicone-11, Propylene Carbonate, Silica, Silica silylate, Tetrasodium EDTA, Tocopheryl Acetate, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Titanium Dioxide (CI 77891).
🎯 Purpose ▾
Uses Helps prevent Sunburn If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun
📄 Keep Out of Reach of Children ▾
If product is swallowed, get medical help or contact Poison Control Center right away.
📖 Instructions for Use ▾
Directions Apply liberally 15 minutes before sun exposure Use water resistant sunscreen if swimming or sweating Repply at least every 2 hours Children under 6 months: Ask a doctor
📄 Package Label / Principal Display Panel ▾
Front and Back label
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
About this NDC listing & data coverage
Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Revlon. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Revlon 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.