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Total Eye 3-In-1 Renewal Therapy SPF 35 Titanium Dioxide and Zinc Oxide 79 mg/mL; 67 mg/mL Liquid — NDC 68078-0024-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Total Eye 3-In-1 Renewal Therapy SPF 35 Titanium Dioxide and Zinc Oxide 79 mg/mL; 67 mg/mL Liquid — NDC 68078-024-01 (Billing 68078-0024-01)

by Colorescience · 1 TUBE in 1 CARTON / 7 mL in 1 TUBE

This is a package of Total Eye 3-In-1 Renewal Therapy SPF 35 Titanium Dioxide and Zinc Oxide 79 mg/mL; 67 mg/mL Liquid from Colorescience, marketed since Jan 2018 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 68078-0024-01
🏷️ FDA NDC (as labeled) 68078-024-01 billing pads the product segment with a zero
This package
Contains7 mL in 1 tube Pack sizes2 compare ↓
Main listing for product 68078-024 · Also comes in: 5 ml 68078-024-02
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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 68078-024-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68078 labeler · 024 product · 01 package
Package marketed since
Jan 19, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6807802401 5
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68078-024-01
Product NDC 68078-024
11-digit billing NDC 68078002401
UNII SOI2LOH54Z, 15FIX9V2JP
Application # M020
SPL Set ID 4b116cc4-94d2-4bfc-b7f9-5f486a194c6c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-01-19
Route TOPICAL
Dosage form LIQUID
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 68078-024-01 — 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 → 68078-0024-01. 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?

Total Eye 3-In-1 Renewal Therapy SPF 35 is a liquid topical product formulated as an over-the-counter sunscreen. The active ingredients, titanium dioxide and zinc oxide, are mineral-based UV filters that work together to protect skin from ultraviolet radiation. This type of sunscreen is typically used to help prevent sunburn and sun damage when applied to the skin around the eyes and face. As an OTC monograph drug, it is marketed under FDA's established category rules for sunscreen products.

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 mLPer 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: 5 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
68078-0024-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 7 mL in 1 TUBE 2018-01-19 — Active
68078-0024-02 68078-024-02 .5 mL in 1 PACKET 2018-01-19 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 7 ml in 1 tube.
What NDC number is used to bill for this package of Total Eye 3-In-1 Renewal Therapy SPF 35 Titanium Dioxide and Zinc Oxide 79 mg/mL; 67 mg/mL Liquid?
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
Total Eye 3-In-1 Renewal Therapy SPF 35 79 mg/mL; 67 mg/mLthis 68078-0024-01 Colorescience 1 tube — — FDA listed —
Total Eye 3-In-1 Renewal Therapy SPF 35 (Fair) 79 mg/mL; 67 mg/mL 68078-0046-01 Colorescience 1 tube — — FDA listed —
Total Eye 3-In-1 Renewal Therapy SPF 35 (Deep) 79 mg/mL; 67 mg/mL 68078-0048-01 Colorescience 1 tube — — FDA listed —
Total Eye 3-In-1 Renewal Therapy SPF 35 (Tan) 79 mg/mL; 67 mg/mL 68078-0047-01 Colorescience 1 tube — — 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

🏛️
2018
On the market since
Jan 2018
📍
2026
Currently FDA-listed
8 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 0J9G6W44DV
    A plant extract from the bark of the silk tree, used as a natural binding and thickening agent in some formulations to help hold ingredients together and add consistency to the medicine.
  • UNII 8C3Z4148WZ
    Alginic acid is a natural polymer extracted from brown seaweed. In medicines, it acts as a thickener, binder, and disintegrant to help form tablets and control how quickly the medicine dissolves.
  • 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 168S4EO8YJ
    A seaweed extract from brown algae, used as a natural binder and thickening agent to help hold tablet ingredients together and improve product texture.
  • UNII 2936KN6I1G
    A red algae used as a natural thickener and stabilizer in medicines. It helps create the right texture and keeps ingredients from separating in liquid or semi-solid formulations.
  • UNII 3SCV180C9W
    Betaine is a naturally occurring organic compound found in plants and animals. In medicines, it acts as an osmoprotectant and stabilizer, helping maintain the product's moisture balance and preserve its chemical stability during storage.
  • 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 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 EG8ODI0780
    Darutoside is a plant-derived compound used as a natural binder and film-former in medications. It helps hold tablet ingredients together and may coat capsules or tablets for controlled release.
  • UNII UF7620L1W6
    A synthetic silicone polymer that acts as a thickener and absorbent in medicines. It helps create the right texture, improves how the product feels on skin or in the mouth, and can absorb excess moisture or oil in formulations.
  • 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 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 F4O1DKI9A6
    A type of algae used as a natural colorant and source of beta-carotene (which gives products an orange-yellow color). It helps color the medication and may provide antioxidant properties to the formulation.
  • 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 EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • 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 73CJJ317SR
    A waxy substance derived from plant oils, used as a binder and lubricant to help hold tablet ingredients together and improve how the medicine flows during manufacturing.
  • 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 7D1YQ9Y5EZ
    Hydrogenated polybutene is a thick, wax-like ingredient made by chemically processing petroleum. It acts as a binder and lubricant, helping hold tablet ingredients together and allowing pills to slide smoothly during manufacturing and packaging.
  • UNII 27F77DSJ5V
    A carbohydrate sweetener made from starch that has been chemically processed and partially broken down. It's used to add sweetness and improve taste in oral medicines, often as a sugar substitute.
  • UNII 7F0EV20QYL
    Jojoba oil is a liquid wax extracted from jojoba plant seeds. In medications, it serves as an emollient and carrier oil that helps soften skin, improve texture, and distribute active ingredients evenly in topical formulations.
  • UNII 113171Q70B
    Lauroyl lysine is a compound made by combining an amino acid (lysine) with a fatty acid (lauric acid). It works as a glidant and lubricant to help powder particles flow smoothly during manufacturing and tablet compression.
  • UNII H49Q67JS3B
    A silicone-based emulsifier and surfactant derived from dimethicone (silicone oil). It helps blend water and oil components in formulations and reduces surface tension, improving product texture and spreadability.
  • 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 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 2A3916MQHO
    A synthetic peptide derived from palm oil that functions as a skin-conditioning agent and emollient. In formulations, it helps soften and smooth the product texture while providing moisturizing properties to topical preparations.
  • 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 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 8KQ7I65XZE
    A waxy compound derived from stearic acid, used as a thickener and emulsifier to help blend oil and water-based ingredients. It improves the texture and stability of the medicine formulation.
  • 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 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 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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 GG8N28393G
    Tremella fuciformis, also called snow fungus, is a white jelly-like mushroom. In medications, it acts as a thickener and stabilizer to give the product a smooth texture and help keep ingredients evenly mixed.
  • 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.

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

The official label also statesAqua/Water, Hydrogenated Polyisobutene, Cyclopentasiloxane, Caprylic/Capric Triglyceride, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Glycerin, Panthenol, Mica, Dimethicone Crosspolymer, Albizia Julibrissin Bark Extract, Sea Water, Sorbitol, Jojoba Esters, Sodium Hyaluronate, Palmitoyl Tripeptide-5, Tremella Fuciformis Sporocarp Extract, Hydrolyzed Algin, Ascophyllum Nodosum Extract, Betaine, Dunaliella Salina Extract, Asparagopsis Armata Extract, Sucrose, Darutoside, Pantolactone, Tocopherol, Sodium Chloride, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Polyhydroxystearic Acid, Glyceryl Behenate/Eicosadioate, Dimethicone, Lauroyl Lysine, Dimethiconol, Ethylhexylglycerin, Triethoxycaprylylsilane, Alumina, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Citric Acid, Iron Oxides (CI 77491, CI 77492, CI 77499)

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

LabelerColorescience
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code68078
First marketedJan 2018
Product typeHuman Otc Drug
Portfolio35 products on file

More NDCs from Colorescience labeler code 68078

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 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 95 words ▾

Directions Apply liberally 15 minutes before sun exposure. Works best on moisturized skin. 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 54 words ▾

Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 11 words ▾

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

🧪 Active Ingredient 11 words ▾

Active ingredients Purpose Titanium Dioxide 7.9% Sunscreen Zinc Oxide 6.7% Sunscreen

🧪 Inactive Ingredients 82 words ▾

Inactive Ingredients Aqua/Water, Hydrogenated Polyisobutene, Cyclopentasiloxane, Caprylic/Capric Triglyceride, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Glycerin, Panthenol, Mica, Dimethicone Crosspolymer, Albizia Julibrissin Bark Extract, Sea Water, Sorbitol, Jojoba Esters, Sodium Hyaluronate, Palmitoyl Tripeptide-5, Tremella Fuciformis Sporocarp Extract, Hydrolyzed Algin, Ascophyllum Nodosum Extract, Betaine, Dunaliella Salina Extract, Asparagopsis Armata Extract, Sucrose, Darutoside, Pantolactone, Tocopherol, Sodium Chloride, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Polyhydroxystearic Acid, Glyceryl Behenate/Eicosadioate, Dimethicone, Lauroyl Lysine, Dimethiconol, Ethylhexylglycerin, Triethoxycaprylylsilane, Alumina, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Citric Acid, Iron Oxides (CI 77491, CI 77492, CI 77499)

🎯 Purpose 11 words ▾

Active ingredients Purpose Titanium Dioxide 7.9% Sunscreen Zinc Oxide 6.7% 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.

📄 Questions or Comments 7 words ▾

Questions or comments? Call toll free 866.426.5673

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton colorescience ® TOTAL EYE ® 3-IN-1 RENEWAL THERAPY + Improves the appearance of: dark circles, fine lines & wrinkles + Brightens & depuffs 35 Broad Spectrum SPF 35 Sunscreen PA+++ ALL-MINERAL ACTIVES 0.23 fl. oz. / 7 mL PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton

PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton - Fair colorescience ® TOTAL EYE ® 3-IN-1 RENEWAL THERAPY + Improves the appearance of: dark circles, fine lines & wrinkles + Brightens & depuffs 35 Broad Spectrum SPF 35 Sunscreen PA+++ ALL-MINERAL ACTIVES 0.23 fl. oz. / 7 mL PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton - Fair

PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton - Tan colorescience ® TOTAL EYE ® 3-IN-1 RENEWAL THERAPY + Improves the appearance of: dark circles, fine lines & wrinkles + Brightens & depuffs 35 Broad Spectrum SPF 35 Sunscreen PA+++ ALL-MINERAL ACTIVES 0.23 fl. oz. / 7 mL PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton - Tan

PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton - Deep colorescience ® TOTAL EYE ® 3-IN-1 RENEWAL THERAPY + Improves the appearance of: dark circles, fine lines & wrinkles + Brightens & depuffs 35 Broad Spectrum SPF 35 Sunscreen PA+++ ALL-MINERAL ACTIVES 0.23 fl. oz. / 7 mL PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton - Deep

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 ✓ 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 Colorescience. 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 5 ml (68078-0024-02). 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?
Colorescience 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.
← 68078-0023-02 · Colorescience 68078-0027-01 · Colorescience →
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.