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LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 Sunscreen Octinoxate and Titanium Dioxide 67 mg/mL; 46 mg/mL Liquid, 30 mL — NDC 49967-0815-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 Sunscreen Octinoxate and Titanium Dioxide 67 mg/mL; 46 mg/mL Liquid, 30 mL — NDC 49967-815-01 (Billing 49967-0815-01)

by L'Oreal USA Products Inc · 30 mL in 1 BOTTLE

This is a package of 30 mL of LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 Sunscreen Octinoxate and Titanium Dioxide 67 mg/mL; 46 mg/mL Liquid from L'Oreal USA Products Inc, marketed since Sep 2024 and currently FDA-listed. It is this product's only package size.

NDC 49967-0815-01
🏷️ FDA NDC (as labeled) 49967-815-01 billing pads the product segment with a zero
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 49967-815-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
49967 labeler · 815 product · 01 package
Package marketed since
Sep 1, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4996781501 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49967-815-01
Product NDC 49967-815
11-digit billing NDC 49967081501
UNII 4Y5P7MUD51, 15FIX9V2JP
Application # M020
SPL Set ID f6457973-3718-44cd-a764-de0b089d4eee
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-09-01
Route TOPICAL
Dosage form LIQUID
Substance OCTINOXATE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 49967-815-01 — 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 → 49967-0815-01. 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?

This is a liquid foundation makeup product applied to the skin that also contains two active sunscreen ingredients. Octinoxate and titanium dioxide are ultraviolet light filters typically used together in sunscreen products to help protect skin from UVA and UVB rays. The product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for over-the-counter sunscreen and cosmetic products rather than being individually reviewed before marketing.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
49967-0815-01 You're viewing this Main listing 30 mL in 1 BOTTLE 2024-09-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 Sunscreen 67 mg/mL; 46 mg/mLthis 49967-0815-01 L'Oreal 30 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 7X6O37OK2I
    A synthetic fragrance compound used as a flavoring agent or aromatic component in medicines. It adds pleasant taste or smell to make the medication more acceptable to patients.
  • UNII P01OUT964K
    A fragrant plant-derived alcohol used as a flavoring agent and fragrance component in medicines. It provides taste and aroma to make the product more pleasant to use.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 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 2V52R0NHXW
    Ascorbyl glucoside is a stable form of vitamin C derived from ascorbic acid and glucose. It functions as an antioxidant in medicines to protect other ingredients from breaking down when exposed to air or light.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII WAO5MNK9TU
    Benzyl salicylate is a fragrant chemical compound used as a flavor and scent ingredient in medicines. It helps mask unpleasant tastes or odors in liquid or oral formulations.
  • UNII X2I70H0QJE
    A silicone-based polymer made from polyethylene glycol and polypropylene glycol chains. It works as an emulsifier and surfactant, helping mix water and oil ingredients together and improving the texture and spreadability of creams, lotions, and other topical products.
  • 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 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 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 3JRB8A35M0
    A mineral compound made from calcium, aluminum, boron, and silicon. It's used as a colorant and opacifying agent to give medicines their appearance and color, and sometimes helps protect ingredients from light damage.
  • UNII J8T3X564IH
    A clear oily liquid derived from sebacic acid, used as a plasticizer and solvent in pharmaceutical coatings and films to improve flexibility and help active ingredients dissolve properly.
  • 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 230K0823CE
    A waxy, fatty substance derived from plant oils. It acts as an emulsifier and thickener in medicines, helping blend oily and water-based ingredients together and giving the product a smooth texture.
  • UNII 45ASM2L11M
    A synthetic ingredient derived from glutamic acid and stearic acid. It acts as an emulsifier and surfactant, helping oils and water mix smoothly in the medication 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 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 WB5K9Y35Y9
    A synthetic crosslinked polymer made by combining hexamethylene diisocyanate with trimethylol hexyllactone. It's used as a film-former and binder to help create protective coatings on tablets or capsules and improve product stability.
  • UNII A8289P68Y2
    Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
  • UNII 9XP4LC555B
    A fragrance compound derived from natural plant sources or made synthetically. It's added to medicines as a flavoring agent to mask bitter tastes and improve how the medicine smells and tastes.
  • UNII LYR06W430J
    A synthetic surfactant derived from coconut oil and amino acids. It works as a cleansing agent and emulsifier in topical medicines, helping to mix oil and water-based ingredients and improve skin penetration.
  • UNII D81QY6I88E
    Linalool is a natural fragrant oil found in plants like lavender and citrus. It's used in medicines as a flavoring agent and to mask unpleasant tastes or smells.
  • UNII 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 V8A1AW0880
    Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
  • UNII 446U8J075B
    Nylon-12 is a synthetic plastic polymer used as a coating or film-forming agent in medicines. It helps create a protective barrier around tablets or capsules to control how and when the medicine is released in the body.
  • UNII 0SG101ZGK9
    Perlite is a naturally occurring volcanic glass that has been heated and expanded. It serves as a lightweight filler and flow agent in solid dosage forms, helping powder mixtures flow smoothly during manufacturing and tablet production.
  • 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 SMD1X3XO9M
    Powdered cellulose is a fine, plant-based powder made from purified wood fibers. In medicines, it acts as a filler to add bulk and volume, and helps tablets or capsules hold together during manufacturing and storage.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII 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.

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

The official label also stateswater, dimethicone, isododecane, alcohol denat., trimethylsiloxysilicate, butylene glycol, PEG-10 dimethicone, perlite, synthetic fluorphlogopite, nylon-12, isopropyl lauroyl sarcosinate, diisopropyl sebacate, HDI /trimethylol hexyllactone crosspolymer,  disteardimonium hectorite, BIS -PEG/PPG-14/14 dimethicone,  magnesium sulfate,  aluminum hydroxide,  phenoxyethanol,  disodium stearoyl glutamate,  hydrogen dimethicone,  cellulose,  dipentaerythrityl tetrahydroxystearate/tetraisostearate,  ascorbyl glucoside,  silica silylate,  fragrance,  calcium aluminum borosilicate,  tocopherol,  silica,  hexyl cinnamal,  benzyl salicylate, BHT,  linalool,  alpha-isomethyl ionone,  benzyl alcohol,  citronellol; may contain:  titanium dioxide,  iron oxides,  bismuth oxychloride,  mica

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

LabelerL'Oreal USA Products Inc
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code49967
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio199 products on file

More NDCs from L'Oreal USA Products Inc labeler code 49967

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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 words ▾

Uses helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

⏱️ Dosage and Administration 100 words ▾

Directions For sunscreen use: shake well beore using apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscren 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 5 words ▾

Warnings For external use only

🧪 Active Ingredient 7 words ▾

Active ingredients Octinoxate 6.7% Titanium dioxide 4.6%

🧪 Inactive Ingredients 73 words ▾

Inactive ingredients water, dimethicone, isododecane, alcohol denat., trimethylsiloxysilicate, butylene glycol, PEG-10 dimethicone, perlite, synthetic fluorphlogopite, nylon-12, isopropyl lauroyl sarcosinate, diisopropyl sebacate, HDI /trimethylol hexyllactone crosspolymer, disteardimonium hectorite, BIS -PEG/PPG-14/14 dimethicone, magnesium sulfate, aluminum hydroxide, phenoxyethanol, disodium stearoyl glutamate, hydrogen dimethicone, cellulose, dipentaerythrityl tetrahydroxystearate/tetraisostearate, ascorbyl glucoside, silica silylate, fragrance, calcium aluminum borosilicate, tocopherol, silica, hexyl cinnamal, benzyl salicylate, BHT, linalool, alpha-isomethyl ionone, benzyl alcohol, citronellol; may contain: titanium dioxide, iron oxides, bismuth oxychloride, mica

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin

📄 When Using This Product 13 words ▾

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

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask a doctor if rash occurs

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Other Information 14 words ▾

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

📄 Questions or Comments 13 words ▾

Questions or comments? 1-800-322-2036 Monday - Friday (10 a.m. - 5 p.m. EST)

📄 Package Label / Principal Display Panel 6 words ▾

image of label

image of PDP

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 L'Oreal USA Products Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
L'Oreal USA Products 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.
← 49967-0812-01 · L'Oreal 49967-0832-01 · L'Oreal →
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.