All Calm Clinical Redness Corrector SPF 50 Titanium Dioxide and Zinc Oxide 116 mg/mL; 86 mg/mL Liquid — NDC 68078-0023-24 package photo

All Calm Clinical Redness Corrector SPF 50 Titanium Dioxide and Zinc Oxide 116 mg/mL; 86 mg/mL Liquid

by Colorescience · 1 TUBE in 1 CARTON (68078-023-24) / 30 mL in 1 TUBE
NDC 68078-0023-24
🏷️ FDA NDC (as labeled) 68078-023-24 billing pads the product segment with a zero
This package
Contains30 mL in 1 tube Pack sizes2 compare ↓
Also comes in: 1 ml 68078-0023-02
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 68078-023-24
Product NDC 68078-023
11-digit billing NDC 68078002324
UNII 15FIX9V2JP, SOI2LOH54Z
Application # M020
SPL Set ID 68b95e94-3686-4d11-9952-ec86394376ee
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-08-02
Route TOPICAL
Dosage form LIQUID
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 68078-023-24 — 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 → 68078-0023-24. 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.

🏭 Manufacturer & labeler

LabelerColorescience
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code68078
First marketedAug 2017
Product typeHuman Otc Drug
Portfolio35 products on file
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.

🩺 Clinical

🧪 What is this product?

All Calm Clinical Redness Corrector SPF 50 is a liquid sunscreen product applied to the skin. It contains titanium dioxide and zinc oxide, which are mineral ingredients commonly used in sunscreens to reflect and scatter ultraviolet light away from the skin. This is an over-the-counter monograph drug, meaning it follows FDA's established rules for sunscreen products rather than being individually reviewed. The product is typically used to help protect skin from sun exposure.

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.

🧪 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 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 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • UNII 5GD84Y125G
    Chloroacetic acid is a chemical compound used in medicines as a buffer or pH adjuster. It helps maintain the correct acidity level so the drug stays stable and works as intended.
  • UNII X5Z09SU859
    A green pigment made from chromium compounds, used to color tablets and capsules. It helps identify the medicine and makes it visually distinctive without affecting how the drug works.
  • UNII J7IHY79BKY
    A plant extract from glasswort, a coastal herb. It's used in formulations as a humectant to help retain moisture and may serve as a skin-conditioning agent in topical products.
  • UNII CZ227117JE
    A silicone-based compound made of linked silicon and oxygen atoms arranged in a ring structure. It acts as a solvent, carrier, or conditioning agent to help distribute active ingredients evenly and improve product texture and spreadability.
  • 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 2KAG279R6R
    Dehydroacetic acid is a synthetic preservative that prevents mold, yeast, and bacterial growth in medicines. It extends shelf life by protecting the product from spoilage during storage and use.
  • 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 0K5Y9U1P6M
    A synthetic compound combining vitamin E derivative with fatty acid chemistry, used as an antioxidant and preservative to prevent ingredient degradation and extend shelf life in medications.
  • 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 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 C5529G5JPQ
    Ginger is a plant-derived ingredient used as a flavoring agent to add taste and aroma to medicines. It may also provide mild soothing properties to support product palatability.
  • 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 0WT12SX38S
    Glycolic acid is an alpha-hydroxy acid derived from sugar cane that helps dissolve and remove dead skin cells. In topical medicines, it works as an exfoliant and pH adjuster to improve skin penetration and product effectiveness.
  • 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 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 5M609NV974
    A plant extract from magnolia bark used as a natural flavoring agent and preservative in medicines. It may help mask bitter tastes and protect the product from spoilage.
  • 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 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 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 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 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 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 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.

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

The official label also statesCyclopentasiloxane, Caprylic/Capric Triglyceride, Water/Aqua/Eau, Dimethicone Crosspolymer, Niacinamide, Disteardimonium Hectorite, Dimethicone/Vinyl Dimethicone Crosspolymer, Propylene Carbonate, Disodium Lauriminodipropionate Tocopheryl Phosphates, Crithmum Maritimum Extract, Magnolia Officinalis Bark Extract, Zingiber Officinale (Ginger) Root Extract, Magnesium Carboxymethyl Beta-Glucan, Jojoba Esters, Bisabolol, Silica, Polyhydroxystearic Acid, Dimethiconol, Alumina, Glyceryl Behenate/Eicosadioate, Phenoxyethanol, Triethoxycaprylylsilane, Ethylhexylglycerin, Tocopherol, Dehydroacetic Acid, Benzoic Acid, Glycolic Acid, Chloroacetic Acid, Chromium Oxide Greens (CI 77288), 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 DailyMedingredient 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.

💲 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: 1 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Even Up Sunscreen SPF 50 116 mg/mL; 86 mg/mL 68078-0003-02 Colorescience 1 ml FDA listed
All Calm Clinical Redness Corrector SPF 50 116 mg/mL; 86 mg/mLthis 68078-0023-24 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

🏛️
2017
On the market since
Aug 2017
📍
2026
Currently FDA-listed
9 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.

🔬 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 All Calm Clinical Redness Corrector SPF 50 (this brand).

Top reported reactions

Acute Myeloid Leukaemia1
Exposure To Toxic Agent1
Product Contamination Chemical1

Age at onset

Adolescent1

Reporter sex

1 reports
Female · 100%
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 1 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68078-0023-02 1 mL in 1 PACKET (68078-023-02) 2017-08-02 Active
68078-0023-24 You're viewing this 1 TUBE in 1 CARTON (68078-023-24) / 30 mL in 1 TUBE 2017-08-02 Active

Pack size FAQ

What quantity is in NDC 68078-0023-24?
NDC 68078-0023-24 is listed by the FDA — 1 tube in 1 carton / 30 ml in 1 tube.
What NDC number is used to bill for this package of All Calm Clinical Redness Corrector SPF 50 Titanium Dioxide and Zinc Oxide 116 mg/mL; 86 mg/mL Liquid?
Bill NDC 68078-0023-24 — the 11-digit billing format is 68078002324. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 68078-023-24, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68078-0023-24, written without dashes as 68078002324. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68078-0023-24, the first segment (68078) is the labeler code FDA assigned to Colorescience; the middle segment (0023) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (24) identifies this exact package size and type. Together they name one specific package of one specific product.
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 ml (68078-0023-02). 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.

📄 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 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 96 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 11.6% Sunscreen Zinc Oxide 8.6% Sunscreen

🧪 Inactive Ingredients 70 words

Inactive ingredients Cyclopentasiloxane, Caprylic/Capric Triglyceride, Water/Aqua/Eau, Dimethicone Crosspolymer, Niacinamide, Disteardimonium Hectorite, Dimethicone/Vinyl Dimethicone Crosspolymer, Propylene Carbonate, Disodium Lauriminodipropionate Tocopheryl Phosphates, Crithmum Maritimum Extract, Magnolia Officinalis Bark Extract, Zingiber Officinale (Ginger) Root Extract, Magnesium Carboxymethyl Beta-Glucan, Jojoba Esters, Bisabolol, Silica, Polyhydroxystearic Acid, Dimethiconol, Alumina, Glyceryl Behenate/Eicosadioate, Phenoxyethanol, Triethoxycaprylylsilane, Ethylhexylglycerin, Tocopherol, Dehydroacetic Acid, Benzoic Acid, Glycolic Acid, Chloroacetic Acid, Chromium Oxide Greens (CI 77288), Iron Oxides (CI 77491, CI 77492, CI 77499).

🎯 Purpose 11 words

Active ingredients Purpose Titanium Dioxide 11.6% Sunscreen Zinc Oxide 8.6% Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.