RE-NUTRIV AGE REVERSAL VITAL RADIANCE SERUM FOUNDATION SPF 20 OCTINOXATE and TITANIUM DIOXIDE 40 mg/mL; 14 mg/mL Emulsion — NDC 11559-0068-01 package photo

RE-NUTRIV AGE REVERSAL VITAL RADIANCE SERUM FOUNDATION SPF 20 OCTINOXATE and TITANIUM DIOXIDE 40 mg/mL; 14 mg/mL Emulsion

by ESTEE LAUDER INC · 1 BOTTLE in 1 CARTON (11559-068-01) / 30 mL in 1 BOTTLE
NDC 11559-0068-01
🏷️ FDA NDC (as labeled) 11559-068-01 billing pads the product segment with a zero
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) 11559-068-01
Product NDC 11559-068
11-digit billing NDC 11559006801
UNII 4Y5P7MUD51, 15FIX9V2JP
Application # M020
SPL Set ID 53d76b02-442e-7a5d-e063-6394a90ae1b3
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-17
Route TOPICAL
Dosage form EMULSION
Substance OCTINOXATE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 11559-068-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 11559-0068-01. 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.

🏭 Manufacturer & labeler

LabelerESTEE LAUDER INC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code11559
First marketedJun 2026
Product typeHuman Otc Drug
Portfolio23 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?

This is a topical emulsion foundation with built-in sun protection, marketed as an over-the-counter product under FDA's sunscreen rule. It contains two active ingredients that function as ultraviolet filters: octinoxate and titanium dioxide. These ingredients are commonly used together in sunscreens and tinted moisturizers to help protect skin from UVA and UVB rays. The product is formulated as a liquid emulsion applied to the face and typically provides SPF 20 coverage.

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 X6I62755AK
    A synthetic fragrance compound used in small amounts to provide or enhance the scent profile of the medication. It helps mask unpleasant tastes or odors that may be present in the active ingredients.
  • UNII V956696549
    N-Acetylglucosamine is a naturally occurring sugar compound derived from chitin. In medicines, it typically serves as a filler or binding agent to help hold tablet ingredients together and add bulk to the formulation.
  • UNII L4EL31FWIL
    A synthetic peptide (short chain of amino acids) used as a conditioning or texture-enhancing agent in topical formulations. It helps improve product feel and skin compatibility in creams and lotions.
  • 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 5QB0T2IUN0
    Aluminum hydroxide is a white powder mineral compound used as an antacid ingredient in some formulations. It works as a buffer and pH regulator to help neutralize stomach acid in the medicine.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 4ZR792I587
    Bismuth oxychloride is a white powder derived from bismuth metal. In medicines, it's used mainly as a colorant and opacifying agent to give tablets or capsules their appearance and to make liquid formulations less transparent.
  • UNII 6G823JVR48
    Black truffle is a culinary fungus used as a flavoring and coloring agent in medicines. It provides natural dark color and distinctive taste to make the medication more palatable, particularly in liquid or chewable formulations.
  • 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 3G6A5W338E
    Caffeine is a natural stimulant compound commonly extracted from coffee beans and tea leaves. In medicines, it serves as an active booster in pain relievers and cold products to enhance alertness and improve the effectiveness of other ingredients.
  • 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 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 YY7C30VXJT
    A natural plant extract from cucumber that adds flavor and freshness to medicines. It may also serve as a moisturizing agent or mild preservative in topical or oral formulations.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 9E4CO0W6C5
    A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
  • UNII 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 B7I80BVV5E
    A fatty acid ester derived from plant oils or synthesized sources. It acts as an emollient and texture enhancer in topical formulations, helping the medicine spread smoothly on skin and improving product consistency.
  • 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 R9N3379M4Z
    Sunflower seed is a plant-derived ingredient used as a filler and source of oil in medications. It helps add bulk to the formulation and may serve as a natural binding or lubricating component.
  • UNII 151Z7P1317
    Hexyldecanol is a waxy alcohol derived from natural oils. It acts as an emollient and viscosity agent in topical formulations, helping create smooth texture and improve product spreadability on skin.
  • UNII KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
  • UNII 8JBE478M5Q
    A plant-derived ingredient made from whole barley grain. It's used as a filler to add bulk and texture to the medicine form.
  • UNII 918X1OUF1E
    Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
  • UNII 15E7C67EE8
    A natural seaweed extract used as a thickener and gelling agent in medicines. It helps create the right texture and consistency in liquid or semi-solid formulations.
  • UNII Z95S6G8201
    A synthetic surfactant derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oily and watery ingredients in liquid formulations, and may improve how the medicine spreads or is absorbed.
  • 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 ZYZ076G9JH
    Lens culinaris fruit is a plant-derived ingredient from lentil plants. It serves as a filler and source of plant-based material in formulations.
  • UNII 5K47SSQ51G
    A fragrant compound found in plants like lavender and bergamot. It's used as a flavoring and aroma agent to improve the taste and smell of medications.
  • UNII DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII 6777U11MKT
    A silicone-based lubricant and anti-foaming agent used to reduce surface tension and prevent foam formation during manufacturing and storage of the medication.
  • UNII S73ZQI0GXM
    Methyl trimethicone is a silicone-based lubricant and glidant used in tablets and capsules. It reduces friction between particles and equipment during manufacturing, helping the medicine flow smoothly and compress evenly.
  • UNII K17762966S
    A natural plant extract from the narcissus bulb used as a flavoring or fragrance ingredient in some medicines. It may help improve taste or smell of the product.
  • UNII 8PR7V1SVM0
    A silicone-based lubricant combined with polyethylene glycol. It reduces friction and helps the medicine flow smoothly during manufacturing and improves how the product feels when applied or swallowed.
  • UNII 9H0AO7T794
    A silicone-based lubricant mixed with polyethylene glycol and polypropylene glycol polymers. It reduces friction between pill surfaces and equipment during manufacturing, and helps the finished product slide smoothly when swallowed.
  • UNII 255PIF62MS
    A synthetic antioxidant compound used to prevent oils and fats in medications from breaking down or becoming rancid during storage. It helps maintain the medicine's stability and shelf life.
  • 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 DR0K5NOJ4R
    Phenyl trimethicone is a silicone-based lubricant and glidant. It helps powder particles flow smoothly and reduces friction during tablet or capsule manufacturing and filling.
  • UNII HCT9WH7ZV9
    A synthetic silicone polymer used as a glidant and anti-caking agent in tablet and capsule formulations. It reduces friction between particles, helping powders flow smoothly during manufacturing and preventing clumping.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII 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 U783H9JHWY
    A synthetic oily liquid used as an emulsifier and solvent in medicines. It helps blend oil and water-based ingredients together and improves how active drugs dissolve and spread through the formulation.
  • UNII B423VGH5S9
    A natural fruit ingredient derived from apples, used as a flavoring agent and sweetener to improve taste and palatability of the medicine.
  • UNII PIX900CCQR
    Sesbania grandiflora flower is a natural plant extract used as a colorant and flavoring agent in medications. It adds color and taste to make the medicine more appealing without affecting how the drug works.
  • 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 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 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 YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII 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 469OTG57A2
    Sodium pyrrolidone carboxylate is a synthetic polymer derived from pyrrolidone chemistry. It functions as a solubilizer and binder in medications, helping dissolve poorly water-soluble drugs and hold tablet ingredients together.
  • UNII 0W8RRI5W5A
    A fatty acid derivative used as an emulsifier and surfactant in medications. It helps blend oily and water-based ingredients together to create a stable, uniform product.
  • UNII NVZ4I0H58X
    A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 2JU6ZH6GRE
    A synthetic fragrance compound made by modifying naphthalene molecules. It's used in very small amounts to add pleasant scent to medications, making them more appealing to take.
  • UNII 8OC9U7TQZ0
    Tribehenin is a waxy, plant-derived substance that acts as a lubricant and glidant in tablets and capsules. It helps the medicine flow smoothly during manufacturing and prevents sticking during production and packaging.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
  • UNII 5041RX63GN
    A synthetic silicon-based polymer used as a glidant and anti-caking agent. It helps powder particles flow smoothly and prevents clumping during manufacturing and storage.
  • 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 231473QB6R
    Watermelon is a fruit extract or flavoring agent. It's added to medicines to improve taste, making the product more palatable, especially for children or medications with unpleasant flavors.
  • UNII 14C97E680P
    Wheat germ oil is an oil extracted from wheat kernels. It's used in medicines as an emollient and lubricant to improve texture and help ingredients blend smoothly.
  • UNII 8617Z5FMF6
    Whey is a milk-derived protein and carbohydrate byproduct. It functions as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the formulation.
  • 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.

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

The official label also statesWATER\AQUA\EAU,PHENYL TRIMETHICONE,METHYL TRIMETHICONE,DIMETHICONE,BUTYLENE GLYCOL,GLYCERIN,HEXYLDECANOL,TRIMETHYLSILOXYSILICATE,PEG-10 DIMETHICONE,PEG/PPG-18/18 DIMETHICONE,ISOHEXADECANE,SORBITAN SESQUIOLEATE,MAGNESIUM SULFATE,TRIBEHENIN,ACETYL GLUCOSAMINE,POLYPHENYLSILSESQUIOXANE,SODIUM HYALURONATE,HELIANTHUS ANNUUS (SUNFLOWER) SEED EXTRACT,CITRULLUS LANATUS (WATERMELON) FRUIT EXTRACT,SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,LENS ESCULENTA (LENTIL) FRUIT EXTRACT,PYRUS MALUS (APPLE) FRUIT EXTRACT,HORDEUM VULGARE EXTRACT\EXTRAIT D'ORGE,CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT,LAMINARIA DIGITATA EXTRACT,SESBANIA GRANDIFLORA FLOWER EXTRACT,NARCISSUS TAZETTA BULB EXTRACT,TUBER MELANOSPORUM EXTRACT,CAFFEINE,PROPYLENE GLYCOL DICAPRATE,WHEAT GERM GLYCERIDES,LAUROYL LYSINE,CAPRYLYL GLYCOL,TRIETHYL CITRATE,WHEY PROTEIN\LACTIS PROTEIN\PROTÉINE DU PETIT-LAIT,SODIUM LACTATE,HYDROGENATED PHOSPHATIDYLCHOLINE,METHICONE,ETHYLHEXYL HYDROXYSTEARATE,SODIUM PCA,ACETYL HEXAPEPTIDE-8,ALUMINUM HYDROXIDE,SILICA,DISTEARDIMONIUM HECTORITE,BORON NITRIDE,LAURETH-7,SORBITAN STEARATE,STEARIC ACID,HEXYLENE GLYCOL,PROPYLENE CARBONATE,POLYSILICONE-11,HYDROGEN DIMETHICONE,XANTHAN GUM,FRAGRANCE (PARFUM),TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES,LINALYL ACETATE,ACETYL CEDRENE,TOCOPHERYL ACETATE,PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE,BHT,PHENOXYETHANOL,CHLORPHENESIN,SODIUM BENZOATE,POTASSIUM SORBATE,TITANIUM DIOXIDE (CI 77891),IRON OXIDES (CI 77491),IRON OXIDES (CI 77492),IRON OXIDES (CI 77499),BISMUTH OXYCHLORIDE (CI 77163) <ILN55655>

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.
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
Re-Nutriv Age Reversal Vital Radiance Serum Foundation Spf 20 40 mg/mL; 14 mg/mLthis 11559-0068-01 ESTEE 1 bottle 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

🏛️
2026
On the market since
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 OCTINOXATE and TITANIUM DIOXIDE — the ingredient across all brands.

Top reported reactions

Asphyxia1
Blister1
Dyspnoea1
Eye Disorder1
Eye Pain1
Eye Swelling1
Gingival Blister1

Reporter sex

1 reports
Female · 100%
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
11559-0068-01 You're viewing this 1 BOTTLE in 1 CARTON (11559-068-01) / 30 mL in 1 BOTTLE 2026-06-17 Active

🧭 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 11559-068-01, 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: 11559-0068-01, written without dashes as 11559006801. 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 11559-0068-01, the first segment (11559) is the labeler code FDA assigned to ESTEE LAUDER INC; the middle segment (0068) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 ESTEE LAUDER INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ESTEE LAUDER INC 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 31 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 and evenly 15 minutes before sun exposure reapply at least every two 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 of age: ask a doctor

⚠️ 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 14 words

Other information protect the product in this container from excessive heat and direct sun

🧪 Active Ingredient 7 words

Active ingredients OCTINOXATE 4% TITANIUM DIOXIDE 1.4%

🧪 Inactive Ingredients 99 words

Inactive ingredients WATER\AQUA\EAU,PHENYL TRIMETHICONE,METHYL TRIMETHICONE,DIMETHICONE,BUTYLENE GLYCOL,GLYCERIN,HEXYLDECANOL,TRIMETHYLSILOXYSILICATE,PEG-10 DIMETHICONE,PEG/PPG-18/18 DIMETHICONE,ISOHEXADECANE,SORBITAN SESQUIOLEATE,MAGNESIUM SULFATE,TRIBEHENIN,ACETYL GLUCOSAMINE,POLYPHENYLSILSESQUIOXANE,SODIUM HYALURONATE,HELIANTHUS ANNUUS (SUNFLOWER) SEED EXTRACT,CITRULLUS LANATUS (WATERMELON) FRUIT EXTRACT,SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,LENS ESCULENTA (LENTIL) FRUIT EXTRACT,PYRUS MALUS (APPLE) FRUIT EXTRACT,HORDEUM VULGARE EXTRACT\EXTRAIT D'ORGE,CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT,LAMINARIA DIGITATA EXTRACT,SESBANIA GRANDIFLORA FLOWER EXTRACT,NARCISSUS TAZETTA BULB EXTRACT,TUBER MELANOSPORUM EXTRACT,CAFFEINE,PROPYLENE GLYCOL DICAPRATE,WHEAT GERM GLYCERIDES,LAUROYL LYSINE,CAPRYLYL GLYCOL,TRIETHYL CITRATE,WHEY PROTEIN\LACTIS PROTEIN\PROTÉINE DU PETIT-LAIT,SODIUM LACTATE,HYDROGENATED PHOSPHATIDYLCHOLINE,METHICONE,ETHYLHEXYL HYDROXYSTEARATE,SODIUM PCA,ACETYL HEXAPEPTIDE-8,ALUMINUM HYDROXIDE,SILICA,DISTEARDIMONIUM HECTORITE,BORON NITRIDE,LAURETH-7,SORBITAN STEARATE,STEARIC ACID,HEXYLENE GLYCOL,PROPYLENE CARBONATE,POLYSILICONE-11,HYDROGEN DIMETHICONE,XANTHAN GUM,FRAGRANCE (PARFUM),TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES,LINALYL ACETATE,ACETYL CEDRENE,TOCOPHERYL ACETATE,PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE,BHT,PHENOXYETHANOL,CHLORPHENESIN,SODIUM BENZOATE,POTASSIUM SORBATE,TITANIUM DIOXIDE (CI 77891),IRON OXIDES (CI 77491),IRON OXIDES (CI 77492),IRON OXIDES (CI 77499),BISMUTH OXYCHLORIDE (CI 77163) <ILN55655>

🎯 Purpose 2 words

Purpose 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.