Home › NDC Lookup › Ingredients › Titanium Dioxide And Zinc Oxide › 68078-0004-02
Sunforgettable Tint du Soleil Foundation SPF 30 Sunscreen Titanium Dioxide and Zinc Oxide 48 mg/mL; 67 mg/mL Liquid, 1 mL — NDC 68078-0004-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sunforgettable Tint du Soleil Foundation SPF 30 Sunscreen Titanium Dioxide and Zinc Oxide 48 mg/mL; 67 mg/mL Liquid, 1 mL — NDC 68078-004-02 (Billing 68078-0004-02)

by Colorescience · 1 mL in 1 PACKET

This is a package of 1 mL of Sunforgettable Tint du Soleil Foundation SPF 30 Sunscreen Titanium Dioxide and Zinc Oxide 48 mg/mL; 67 mg/mL Liquid from Colorescience, marketed since Oct 2015 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 68078-0004-02
🏷️ FDA NDC (as labeled) 68078-004-02 billing pads the product segment with a zero
This package
Contains1 mL Pack sizes2 compare ↓
Main listing for product 68078-004 · Also comes in: 30 mL 68078-004-05
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 →

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 68078-004-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68078 labeler · 004 product · 02 package
Package marketed since
Oct 5, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6807800402 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68078-004-02
Product NDC 68078-004
11-digit billing NDC 68078000402
UNII 15FIX9V2JP, SOI2LOH54Z
Application # M020
SPL Set ID 219e2ef4-e977-4527-8999-14b27d5a7a33
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-10-05
Route TOPICAL
Dosage form LIQUID
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 68078-004-02 — 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 → 68078-0004-02. 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 a liquid foundation sunscreen applied to the skin that contains titanium dioxide and zinc oxide as active ingredients. Both minerals function as broad-spectrum UV filters, commonly used in sunscreen products to help block ultraviolet radiation from the sun. The product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established safety and effectiveness standards for sunscreen ingredients rather than being individually approved through a separate application. It is formulated to provide sun protection while also serving as a tinted cosmetic foundation.

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: 30 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
68078-0004-02 You're viewing this Main listing 1 mL in 1 PACKET 2015-10-05 — Active
68078-0004-05 68078-004-05 1 TUBE in 1 CARTON / 30 mL in 1 TUBE 2015-10-05 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 mL — 1 ml in 1 packet.
What NDC number is used to bill for this package of Sunforgettable Tint du Soleil Foundation SPF 30 Sunscreen Titanium Dioxide and Zinc Oxide 48 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
Sunforgettable Tint du Soleil Foundation SPF 30 Sunscreen 48 mg/mL; 67 mg/mLthis 68078-0004-02 Colorescience 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.

Availability & generic status

🏛️
2015
On the market since
Oct 2015
📍
2026
Currently FDA-listed
11 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 SMF2K46G8D
    A red algae extract used as a gelling agent and thickener in medicines. It forms a gel-like consistency that helps control how the medicine releases and is absorbed in the body.
  • 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 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 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 5THT33P7X7
    A waxy, lipid-like substance derived from animal or plant sources. It helps soften and moisturize the skin by acting as an emollient and skin-conditioning agent in topical medicines and creams.
  • UNII F1X8L2B00J
    A naturally derived fatty substance that helps bind and condition the product's texture. It works as an emollient and skin-conditioning agent in topical formulations, helping maintain moisture and smoothness.
  • UNII 4370DF050B
    Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
  • UNII I670DAL4SZ
    A preservative that fights bacteria and fungi. It keeps medicines and topical products stable and safe from microbial contamination during storage and use.
  • UNII 97C5T2UQ7J
    Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
  • 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 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 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 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 OSA9UP217S
    Dimethiconol is a silicone-based lubricant and anti-foaming agent. It reduces friction between tablet components and prevents foam formation during manufacturing and storage.
  • 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 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 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • 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 25G622K2RA
    A silicone-based surfactant that helps blend oil and water in cosmetic or topical formulations. It reduces surface tension to improve product spreadability and texture.
  • 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 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 Q41S464P1R
    A synthetic peptide (short protein-like molecule) used in skincare and cosmetic formulations as an active conditioning ingredient to help improve skin texture and appearance. It may function as a humectant or skin-conditioning agent in topical products.
  • UNII RV743D216M
    A synthetic peptide derived from fatty acids and amino acids. It functions as a skin-conditioning agent and emollient in topical formulations, helping soften and smooth the product texture while supporting skin hydration.
  • UNII 3K0J1S7QGC
    A fragrant essential oil derived from geranium flowers, used as a flavoring and fragrance agent to improve the taste and aroma of medicines.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII ML9LGA7468
    A naturally-derived alcohol used as a preservative and fragrance in medicines. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII GIN46U9Q2Q
    Phytosphingosine is a naturally derived fatty compound that helps stabilize and thicken skincare and cosmetic formulations. It works as an emollient and conditioning agent to improve texture and skin feel in topical products.
  • 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 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII H9LVS6REV4
    A natural essential oil derived from Australian sandalwood, used as a fragrance and flavoring agent to make the medicine more pleasant-tasting or better-smelling.
  • 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 836SJG51DR
    Sodium ascorbyl phosphate is a derivative of vitamin C that acts as an antioxidant and preservative in medications. It helps protect the drug's active ingredients from degradation caused by air and light exposure.
  • 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 8W46YN971G
    Sodium dehydroacetate is a salt derived from dehydroacetic acid, a compound used as a preservative. It helps prevent mold, bacteria, and yeast growth in medicines, extending shelf life and maintaining product safety.
  • UNII TU7HW0W0QT
    A salt derived from lactic acid, sodium lactate acts as a buffer and pH stabilizer in medicines. It helps maintain the product's acidity level and can also serve as a humectant to retain moisture.
  • UNII 7243K85WFO
    Sodium lauroyl lactylate is a mild surfactant derived from natural fats and lactic acid. It acts as an emulsifier and solubilizer to help blend oil and water-based ingredients and improve how the body absorbs the active drug.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe 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 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.
  • UNII 8YOY78GNNX
    A fragrant essential oil derived from ylang-ylang tree flowers. It's used as a flavoring and fragrance agent to improve the taste or scent of medicines.

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

The official label also statesCyclopentasiloxane, Water, Mica, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone, Glycerin, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Butylene Glycol, Caprylyl Glycol, Dimethiconol, Silica, Jojoba Esters, Lauroyl Lysine, Polyhydroxystearic Acid, Ahnfeltia Concinna Extract, Glyceryl Behenate/Eicosadioate, Alumina, Sodium Lauroyl Lactylate, Phenethyl Alcohol, Tocopheryl Acetate, Cananga Odorata Flower Oil, Carbomer, Sodium Lactate, Sodium Ascorbyl Phosphate, Fusanus Spicatus Wood Oil, Polysorbate 20, Ceramide NP, Ceramide AP, Ceramide EOP, Triethoxycaprylylsilane, Phytosphingosine, Cholesterol, Xanthan Gum, Ethylhexylglycerin, Pelargonium Graveolens Flower Oil, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Phenoxyethanol, Chlorphenesin, Sodium Dehydroacetate, Sodium Benzoate, Sorbic Acid, Linalool, Farnesol, 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 marketedOct 2015
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 📄 Do Not Use 📄 Stop Use and Ask a Doctor If 📄 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 97 words ▾

Directions Apply liberally 15 minutes before sun exposure. Works best on moisturized skin. Reapply: After 40 minutes of swimming or sweating.

Immediately after towel drying. At least every 2 hours. 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 53 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 4.8% Sunscreen Zinc Oxide 6.7% Sunscreen

🧪 Inactive Ingredients 97 words ▾

Inactive ingredients Cyclopentasiloxane, Water, Mica, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone, Glycerin, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Butylene Glycol, Caprylyl Glycol, Dimethiconol, Silica, Jojoba Esters, Lauroyl Lysine, Polyhydroxystearic Acid, Ahnfeltia Concinna Extract, Glyceryl Behenate/Eicosadioate, Alumina, Sodium Lauroyl Lactylate, Phenethyl Alcohol, Tocopheryl Acetate, Cananga Odorata Flower Oil, Carbomer, Sodium Lactate, Sodium Ascorbyl Phosphate, Fusanus Spicatus Wood Oil, Polysorbate 20, Ceramide NP, Ceramide AP, Ceramide EOP, Triethoxycaprylylsilane, Phytosphingosine, Cholesterol, Xanthan Gum, Ethylhexylglycerin, Pelargonium Graveolens Flower Oil, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Phenoxyethanol, Chlorphenesin, Sodium Dehydroacetate, Sodium Benzoate, Sorbic Acid, Linalool, Farnesol, Iron Oxides (CI 77491, CI 77492, CI 77499).

🎯 Purpose 11 words ▾

Active ingredients Purpose Titanium Dioxide 4.8% Sunscreen Zinc Oxide 6.7% Sunscreen

📄 Do Not Use 20 words ▾

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 9 words ▾

Stop use and ask a doctor if rash occurs.

📄 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 59 words ▾

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton colorescience ® TINT DU SOLEIL ® WHIPPED FOUNDATION + Creamy and lightweight + Comforting hydration + Helps improve appearance of lines and wrinkles 30 Broad Spectrum SPF 30 Sunscreen ALL-MINERAL ACTIVES WATER/SWEAT RESISTANT (40 MINUTES) Net Wt. 1 fl. oz. / 30 mL PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

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 Titanium Dioxide and Zinc Oxide — the ingredient across all brands.

Top reported reactions

Hypersensitivity4
Posture Abnormal4
Seizure Like Phenomena4
Blister3
Dermatitis Contact3
Eye Movement Disorder3
Urticaria3

Age at onset

Adolescent1

Reporter sex

24 reports
Male · 21%
Female · 67%
Unknown · 13%

Serious outcomes

Death2
Hospitalization1
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 11 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 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 1 tube (68078-0004-05). 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.
← 68078-0003-02 · Colorescience 68078-0013-14 · 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.