Home › NDC Lookup › Ingredients › Titanium Dioxide Zinc Oxide › 64651-1003-03
Intellishade TruPhysical SPF 45 Titanium Dioxide, Zinc Oxide 4.4 g/100g; 14.4 g/100g Lotion, 3 g — NDC 64651-1003-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Intellishade TruPhysical SPF 45 Titanium Dioxide, Zinc Oxide 4.4 g/100g; 14.4 g/100g Lotion, 3 g — NDC 64651-1003-3 (Billing 64651-1003-03)

by Revision, LLC · 3 g in 1 TUBE

This is a package of 3 g of Intellishade TruPhysical SPF 45 Titanium Dioxide, Zinc Oxide 4.4 g/100g; 14.4 g/100g Lotion from Revision, LLC, marketed since Mar 2018 and currently FDA-listed.

NDC 64651-1003-03
🏷️ FDA NDC (as labeled) 64651-1003-3 billing pads the package segment with a zero
This package
Contains3 g Pack sizes3 compare ↓
Product page 64651-1003-01 Also comes in: 48 g 64651-1003-1 227 g 64651-1003-2
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 64651-1003-3 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
64651 labeler · 1003 product · 3 package
Package marketed since
Mar 5, 2018
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2027
Barcode (UPC)
0640451095905
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Titanium Dioxide, Zinc Oxide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 3, 2024 — Microbial Contamination of Non-Sterile Product (Vivier Pharma, Inc.) · FDA recall D-0662-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 64651-1003-3
Product NDC 64651-1003
11-digit billing NDC 64651100303
UNII 15FIX9V2JP, SOI2LOH54Z
UPC 0640451095905
Application # M020
SPL Set ID e20f5dc9-e863-b090-e053-2a95a90a5044
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-03-05
Route TOPICAL
Dosage form LOTION
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 64651-1003-3 — a 5-4-1 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 package segment → 64651-1003-03. 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?

Intellishade TruPhysical SPF 45 is a topical sunscreen lotion that contains two mineral UV filters: titanium dioxide and zinc oxide. These inorganic compounds are typically used together to reflect and scatter ultraviolet light away from the skin. This product is marketed as an over-the-counter sunscreen under FDA's monograph rules for the sunscreen category, meaning it follows established safety and effectiveness guidelines for sunscreen ingredients rather than undergoing individual product review.

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 gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 48 g 227 g
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
64651-1003-01 64651-1003-1 Main listing 1 TUBE in 1 CARTON / 48 g in 1 TUBE 2018-03-05 — Active
64651-1003-02 64651-1003-2 227 g in 1 TUBE 2018-03-05 — Active
64651-1003-03 You're viewing this 3 g in 1 TUBE Sample 2018-03-05 — Active

Pack size FAQ

What quantity is in this package?
This package contains 3 g — 3 g in 1 tube.
How does this package differ from NDC 64651-1003-02?
Both are Intellishade TruPhysical SPF 45 Titanium Dioxide, Zinc Oxide 4.4 g/100g; 14.4 g/100g Lotion — the drug itself is identical. This page's package is the 3 g one, while NDC 64651-1003-02 is the 227 g package.
What NDC number is used to bill for this package of Intellishade TruPhysical SPF 45 Titanium Dioxide, Zinc Oxide 4.4 g/100g; 14.4 g/100g Lotion?
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
Intellishade TruPhysical SPF 45 4.4 g/100g; 14.4 g/100gthis 64651-1003-03 Revision, 3 g — — 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
Mar 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.

What it looks like

Color brown
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 H4N855PNZ1
    Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
  • UNII WR1WPI7EW8
    A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
  • UNII A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical 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 2U4T60A6YD
    Boron nitride is a synthetic mineral compound. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and capsules.
  • 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 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 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 609A3V1SUA
    A silky liquid derived from caprylic acid that acts as an emollient and solvent in formulations. It helps dissolve active ingredients and improves the spreadability and feel of lotions, creams, and topical products.
  • 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 BQM438CTEL
    A plant-derived compound from green tea that acts as an antioxidant. It's used in formulations to help prevent degradation of active ingredients and maintain product stability over time.
  • 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 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 D2QHA03458
    A fermented ingredient made by culturing beneficial bacteria in radish root extract. It acts as a natural preservative and humectant, helping keep the product fresh and maintain moisture in the formula.
  • UNII 02F3473H9O
    A mineral salt used in medications as a source of magnesium. It helps bind ingredients together, improve texture, and maintain the product's stability during storage.
  • UNII SK47B8698T
    A mineral compound containing magnesium, sulfate, and water molecules. Used in medicines as a laxative agent and sometimes as a filler or anti-caking ingredient to improve powder flow and stability.
  • 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 O0CV1RMR44
    A dark pigment made synthetically from tyrosine and peroxide. It's used as a colorant in tablets and capsules to give medicines their color and help distinguish different dosages visually.
  • 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 1615WE9073
    This is a synthetic peptide-like compound used as an emulsifier and stabilizer in medications. It helps keep oil and water-based ingredients mixed together and maintains product consistency.
  • 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 9229XJ4V12
    A synthetic emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients in formulations, keeping them mixed and preventing separation.
  • 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 YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • 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 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 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII 9LBV3F07AZ
    A synthetic, oil-soluble form of vitamin C used as an antioxidant to prevent degradation of the medicine and maintain its stability during storage.
  • UNII 415H64SACF
    A heat-loving bacterium used as a probiotic ingredient to support beneficial gut flora. It may help maintain digestive balance when included in supplements or certain foods.
  • 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 I7T5V2W47R
    Ubiquinone Q2 is a naturally occurring compound found in cells that acts as an antioxidant. In medicines, it may serve as a stabilizer or preservative to protect the product from degradation.
  • 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 7G1J5DA97F
    White wax is a refined, bleached plant-based or mineral wax that serves as a coating and hardening agent in medicines. It helps control how fast the drug dissolves and improves the product's texture and appearance.
  • 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 3NY3SM6B8U
    A microorganism used as a natural source of B vitamins and proteins. In medications, yeast serves as a nutrient supplement and may help with tablet binding or act as a filler to give the product proper form and stability.

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

The official label also statesInactive ingredients Water (Aqua), Caprylic/Capric Triglyceride, Thermus Thermophillus Ferment, Polyglyceryl-2 Dipolyhydroxystearate, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Diisostearate, Glycerin, Hydrogenated Starch Hydrolysate, Butylene Glycol, Aloe Barbadensis Leaf Juice, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Plankton Extract, Beeswax (Cera Alba), Acrylates/Dimethicone Copolymer, Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5, Dimethicone/Vinyl Dimethicone Crosspolymer, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Leuconostoc/Radish Root Ferment Filtrate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Melanin, Phenoxyethanol, Silica, Chlorphenesin, Polyhydroxystearic Acid, Xanthan Gum, Magnesium Chloride, Benzoic Acid, Sorbic Acid, Triethoxycaprylylsilane, Magnesium Sulfate, 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

LabelerRevision, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code64651
First marketedMar 2018
Product typeHuman Otc Drug
Portfolio5 products on file

More NDCs from Revision, LLC labeler code 64651

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 62 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

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 22 words ▾

apply liberally 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating

⚠️ Warnings 107 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.

Warnings For external use only When using this product keep out of eyes. Rinse wilth 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. Do not used on damaged or broken skin

🧪 Active Ingredient 26 words ▾

Active ingredient Purpose Zinc Oxide 14.4% ......... Sunscreen Titanium Dioxide 4.4% . Sunscreen

Active ingredient Purpose Zinc Oxide 14.4% ......... Sunscreen Titanium Dioxide 4.4% . Sunscreen

🧪 Inactive Ingredients 214 words ▾

Inactive ingredients Water (Aqua), Caprylic/Capric Triglyceride, Thermus Thermophillus Ferment, Polyglyceryl-2 Dipolyhydroxystearate, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Diisostearate, Glycerin, Hydrogenated Starch Hydrolysate, Butylene Glycol, Aloe Barbadensis Leaf Juice, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Plankton Extract, Beeswax (Cera Alba), Acrylates/Dimethicone Copolymer, Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5, Dimethicone/Vinyl Dimethicone Crosspolymer, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Leuconostoc/Radish Root Ferment Filtrate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Melanin, Phenoxyethanol, Silica, Chlorphenesin, Polyhydroxystearic Acid, Xanthan Gum, Magnesium Chloride, Benzoic Acid, Sorbic Acid, Triethoxycaprylylsilane, Magnesium Sulfate, Iron Oxides (CI 77491, CI 77492, CI 77499)

Inactive ingredients Water (Aqua), Caprylic/Capric Triglyceride, Thermus Thermophillus Ferment, Polyglyceryl-2 Dipolyhydroxystearate, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Diisostearate, Glycerin, Hydrogenated Starch Hydrolysate, Butylene Glycol, Aloe Barbadensis Leaf Juice, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Plankton Extract, Beeswax (Cera Alba), Acrylates/Dimethicone Copolymer, Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5, Dimethicone/Vinyl Dimethicone Crosspolymer, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Leuconostoc/Radish Root Ferment Filtrate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Melanin, Phenoxyethanol, Silica, Chlorphenesin, Polyhydroxystearic Acid, Xanthan Gum, Magnesium Chloride, Benzoic Acid, Sorbic Acid, Triethoxycaprylylsilane, Magnesium Sulfate, Iron Oxides (CI 77491, CI 77492, CI 77499)

🎯 Purpose 12 words ▾

Anti-aging tinted daily moisturizer with 100% mineral sunscreen Broad Spectrum SPF 45

📄 Do Not Use 16 words ▾

Do not use on damaged or broken skin

Do not used on damaged or broken skin

📄 When Using This Product 26 words ▾

When using this product keep out of eyes. Rinse with water to remove.

When using this product keep out of eyes. Rinse wilth water to remove.

📄 Stop Use and Ask a Doctor If 18 words ▾

Stop use and ask a doctor if rash occurs

Stop use and ask a doctor if rash occurs

📄 Keep Out of Reach of Children 37 words ▾

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

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

📄 Other Information 24 words ▾

Other information • protect this product from excessive heat and direct sun

Other information • protect this product from excessive heat and direct sun

📖 Instructions for Use 194 words ▾

Directions • apply liberally 15 minutes before sun exposure • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • 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 • children under 6 months: Ask a doctor

Directions • apply liberally 15 minutes before sun exposure • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • 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 • children under 6 months: Ask a doctor

📄 Package Label / Principal Display Panel 4 words ▾

ITP_carton_retail 1.7oz ITP_retail_carton_1.7oz ITP_pro_tube_8oz

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 Revision, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 tube (64651-1003-01), 227 g (64651-1003-02). 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?
Revision, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 64646-0420-12 · Charlotte 64651-1226-01 · Revision, →
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.