Home › NDC Lookup › Ingredients › Octinoxate, Octisalate, Titanium Dioxide... › 64651-7749-01
Intellishade Original SPF 45 Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide 7.5 g/100g; 5 g/100g; 3.5 g/100g; 3 g/100g Cream — NDC 64651-7749-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Intellishade Original SPF 45 Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide 7.5 g/100g; 5 g/100g; 3.5 g/100g; 3 g/100g Cream — NDC 64651-7749-1 (Billing 64651-7749-01)

by Revision, LLC · 1 TUBE in 1 CARTON / 48 g in 1 TUBE

This is a package of Intellishade Original SPF 45 Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide 7.5 g/100g; 5 g/100g; 3.5 g/100g; 3 g/100g Cream from Revision, LLC, marketed since Jul 2013 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 64651-7749-01
🏷️ FDA NDC (as labeled) 64651-7749-1 billing pads the package segment with a zero
This package
Contains48 g in 1 tube Pack sizes3 compare ↓
Main listing for product 64651-7749 · Also comes in: 3 g 64651-7749-3 227 g 64651-7749-2
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 64651-7749-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
64651 labeler · 7749 product · 1 package
Package marketed since
Jul 9, 2013
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0640451095813
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 64651-7749-1
Product NDC 64651-7749
11-digit billing NDC 64651774901
UNII 4Y5P7MUD51, 4X49Y0596W, 15FIX9V2JP, SOI2LOH54Z
UPC 0640451095813
Application # M020
SPL Set ID e213a681-eb22-69c0-e053-2995a90a899e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-07-09
Route TOPICAL
Dosage form CREAM
Substance OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 64651-7749-1 — 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 → 64651-7749-01. 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?

Intellishade Original SPF 45 is a topical cream containing four active ingredients commonly used as ultraviolet (UV) filters in sunscreen products. Octinoxate and octisalate are organic UV absorbers, while titanium dioxide and zinc oxide function as inorganic UV blockers that reflect and scatter sunlight. This is an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for sunscreen products rather than through individual product approval.

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: 3 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
64651-7749-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 48 g in 1 TUBE 2013-07-09 — Active
64651-7749-02 64651-7749-2 227 g in 1 TUBE 2013-07-09 — Active
64651-7749-03 64651-7749-3 3 g in 1 TUBE Sample 2013-07-09 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 48 g in 1 tube.
What NDC number is used to bill for this package of Intellishade Original SPF 45 Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide 7.5 g/100g; 5 g/100g; 3.5 g/100g; 3 g/100g Cream?
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 Original SPF 45 7.5 g/100g; 5 g/100g; 3.5 g/100g; 3 g/100gthis 64651-7749-01 Revision, 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

🏛️
2013
On the market since
Jul 2013
📍
2026
Currently FDA-listed
13 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 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 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 3R504894L9
    A natural extract from birch tree bark used as a binder and thickening agent. It helps hold tablet ingredients together and may improve the product's texture and consistency.
  • 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 DI775RT244
    A natural fatty acid derived from coconut or palm oil. Used as an emulsifier and solubilizer to help mix oil and water components and improve how the medicine dissolves and absorbs in the body.
  • UNII U4AS1BW4ZB
    Cetyl dimethicone is a silicone-based lubricant and emollient. It helps the medicine spread smoothly, reduces friction between particles, and improves the product's texture and feel.
  • UNII 035JKJ76MT
    A silicone-based ingredient that helps oil and water mix together in formulations. It works as an emulsifier to create smooth, stable textures in topical medicines and creams.
  • 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 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 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 EG3PA2K3K5
    Ethylhexyl stearate is a waxy oil made from stearic acid and ethylhexyl alcohol. In medicines, it acts as an emollient and thickener to improve texture and help the product spread smoothly on skin or dissolve properly.
  • 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 TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • UNII HYE7O27HAO
    Glyceryl isostearate is a fatty substance derived from vegetable oils or animal fats. In medicines, it acts as an emulsifier to blend water and oil components together, and helps form a smooth texture in creams, ointments, and other topical products.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII 4CG9F9W01Q
    A synthetic fatty acid ester used as an emollient and skin-conditioning agent in topical medicines. It helps soften the product texture and improves how it spreads and absorbs into the skin.
  • UNII ZF94AP8MEY
    Hydrogenated castor oil is a processed plant oil made by adding hydrogen to castor oil. It's used as a binder to help hold tablet ingredients together and as a lubricant to prevent sticking during manufacturing.
  • 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 UDR641JW8W
    A plant-derived oil from jojoba seeds that has been broken down into smaller components. It acts as an emollient and skin-conditioning agent to help soften and smooth the product's texture.
  • 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 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 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 820DPX33S7
    A synthetic emulsifier derived from glycerin and fatty acids. It helps mix oil and water-based ingredients together and keeps them evenly blended throughout the product.
  • 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 D24K2Q1F6H
    A plant oil extracted from jojoba seeds. It acts as an emollient and conditioning agent in topical formulations, helping soften skin and improve product texture and spreadability.
  • 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 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 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 0UBP26S1LG
    A synthetic compound used in pharmaceuticals as a penetration enhancer and formulation agent. It helps active ingredients absorb more effectively through skin or membranes in topical and transdermal medicine formulations.
  • 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 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 EJ27X76M46
    Ubidecarenone is a naturally occurring compound found in cells that helps produce energy. In medicines, it acts as an antioxidant and may help stabilize the product while supporting cellular function in the body.
  • 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.

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

The official label also statesInactive ingredients Water (Aqua), Cyclopentasiloxane, Jojoba Esters, Hydrogenated Starch Hydrolysate, Caprylic/Capric Triglyceride, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Butylene Glycol, Cetyl Dimethicone, Ethylhexyl Palmitate, Ethylhexyl Stearate, Aloe Barbadensis Leaf Juice, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Plankton Extract, Beeswax (Cera Alba), Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5, Hydrogenated Castor Oil, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Glyceryl Caprylate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Sodium Chloride, Phenoxyethanol, Glyceryl Isostearate, Chlorphenesin, Polyhydroxystearic Acid, Xanthan Gum, Magnesium Chloride, Triethoxycaprylylsilane, Benzoic Acid, Sorbic 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

LabelerRevision, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code64651
First marketedJul 2013
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 108 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 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.

🧪 Active Ingredient 40 words ▾

Active ingredient Purpose Octinoxate 7.5% ............ Sunscreen Octisalate 5% ................ Sunscreen Titanium Dioxide 3.5%... Sunscreen Zinc Oxide 3% ............... Sunscreen

Active ingredient Purpose Octinoxate 7.5% ............ Sunscreen Octisalate 5% ................ Sunscreen Titanium Dioxide 3.5%... Sunscreen Zinc Oxide 3% ............... Sunscreen

🧪 Inactive Ingredients 210 words ▾

Inactive ingredients Water (Aqua), Cyclopentasiloxane, Jojoba Esters, Hydrogenated Starch Hydrolysate, Caprylic/Capric Triglyceride, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Butylene Glycol, Cetyl Dimethicone, Ethylhexyl Palmitate, Ethylhexyl Stearate, Aloe Barbadensis Leaf Juice, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Plankton Extract, Beeswax (Cera Alba), Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5, Hydrogenated Castor Oil, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Glyceryl Caprylate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Sodium Chloride, Phenoxyethanol, Glyceryl Isostearate, Chlorphenesin, Polyhydroxystearic Acid, Xanthan Gum, Magnesium Chloride, Triethoxycaprylylsilane, Benzoic Acid, Sorbic Acid, Iron Oxides (CI 77491, CI 77492, CI 77499)

Inactive ingredients Water (Aqua), Cyclopentasiloxane, Jojoba Esters, Hydrogenated Starch Hydrolysate, Caprylic/Capric Triglyceride, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Butylene Glycol, Cetyl Dimethicone, Ethylhexyl Palmitate, Ethylhexyl Stearate, Aloe Barbadensis Leaf Juice, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Plankton Extract, Beeswax (Cera Alba), Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5, Hydrogenated Castor Oil, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Glyceryl Caprylate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Sodium Chloride, Phenoxyethanol, Glyceryl Isostearate, Chlorphenesin, Polyhydroxystearic Acid, Xanthan Gum, Magnesium Chloride, Triethoxycaprylylsilane, Benzoic Acid, Sorbic Acid, Iron Oxides (CI 77491, CI 77492, CI 77499)

🎯 Purpose 12 words ▾

Anti-aging untinted daily moisturizer with 100% mineral sunscreen Broad Spectrum SPF 50

📄 Do Not Use 16 words ▾

Do not use on damaged or broken skin

Do not use 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 with 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 38 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 3 words ▾

ITO_carton_retail_1.7oz ITO_tube_retail_1.7oz ITO_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 3 g (64651-7749-03), 227 g (64651-7749-02). 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.
← 64651-7720-01 · Revision, 64657-0007-02 · Naturopathica →
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.