Home › NDC Lookup › Ingredients › Octinoxate, Titanium Dioxide › 65342-2340-01
Laura Mercier Flawless Skin Daily Face Shield SPF 40 OCTINOXATE, TITANIUM DIOXIDE 75 mg/mL; 50 mg/mL Liquid, 30 mL — NDC 65342-2340-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Laura Mercier Flawless Skin Daily Face Shield SPF 40 OCTINOXATE, TITANIUM DIOXIDE 75 mg/mL; 50 mg/mL Liquid, 30 mL — NDC 65342-2340-1 (Billing 65342-2340-01)

by Gurwitch Products, LLC · 30 mL in 1 TUBE

This is a package of 30 mL of Laura Mercier Flawless Skin Daily Face Shield SPF 40 OCTINOXATE, TITANIUM DIOXIDE 75 mg/mL; 50 mg/mL Liquid from Gurwitch Products, LLC, marketed since Apr 2011 and currently FDA-listed. It is this product's only package size.

NDC 65342-2340-01
🏷️ FDA NDC (as labeled) 65342-2340-1 billing pads the package 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 65342-2340-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
65342 labeler · 2340 product · 1 package
Package marketed since
Dec 19, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6534223401 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65342-2340-1
Product NDC 65342-2340
11-digit billing NDC 65342234001
UNII 4Y5P7MUD51, 15FIX9V2JP
Application # M020
SPL Set ID f86729cd-682f-47b2-9bfa-1113721bfec0
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-04-21
Route TOPICAL
Dosage form LIQUID
Substance OCTINOXATE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 65342-2340-1 — 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 → 65342-2340-01. 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 topical liquid sunscreen lotion marketed as a daily facial moisturizer with sun protection. It contains two UV filters, octinoxate and titanium dioxide, which are commonly used together in sunscreen products to reflect and absorb ultraviolet light. The product is classified as an over-the-counter monograph drug, meaning it is formulated according to FDA's established rules for sunscreen products rather than approved through an individual application review. It is typically applied to the face as part of a daily skincare routine.

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
65342-2340-01 You're viewing this Main listing 30 mL in 1 TUBE 2017-12-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Laura Mercier Flawless Skin Daily Face Shield SPF 40 75 mg/mL; 50 mg/mLthis 65342-2340-01 Gurwitch 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

🏛️
2011
On the market since
Apr 2011
📍
2026
Currently FDA-listed
15 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 LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII 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 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 NMQ347994Z
    Cyclomethicone is a silicone-based fluid that acts as a lubricant and solvent in medicines. It helps products flow smoothly, reduces friction between particles, and aids in even distribution of active ingredients.
  • 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 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII ZQH6VH092Z
    Eleuthero is a plant extract used in some formulations as a natural flavoring agent or botanical ingredient. It may help enhance taste or provide traditional herbal properties to the medicine.
  • 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 CA2Y0FE3FX
    A salt derived from licorice root extract, used as a flavoring agent and sweetener. It may also help soothe and protect mucous membranes in throat lozenges and cough products.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • 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 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 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 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.

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

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

LabelerGurwitch Products, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code65342
First marketedApr 2011
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from Gurwitch Products, LLC labeler code 65342

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.
⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🎯 Purpose 📋 Description 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
⏱️ Dosage and Administration 37 words ▾

Directions for use: After moisturizing, shake bottle, and apply a small amount onto fingertips and smooth all over face and neck. For SPF 40 protection, apply generously to cleansed skin prior to sum exposure. Reapply as needed.

⚠️ Warnings 9 words ▾

WARNINGS: FOR EXTERNAL USE ONLY. NOT TO BE SWALLOWED

🧪 Active Ingredient 8 words ▾

Active Ingredient: Octyl Methoxycinnamate (7.50%), Titanium Dioxide (5.00%).

🎯 Purpose 4 words ▾

FOR ADULT USE ONLY.

📋 Description 95 words ▾

DAILY FACE SHIELD SPF 40 This weightless oil-free sunscreen goes on sheer, with no oily residue, to help shield skin from damaging sunrays and seasonal changes. Daily Face Shield SPF 40 helps: - Create an invisible shield against damaging UVA and UVB rays, preventing visible signs of aging - Formulated with Adaptogen technology which may help the skin adapt to seasonal changes. DERMATOLOGICALLY AND ALLERGY TESTED TO MINIMIZE THE RISK OF ALLERGY AND IRRITATION.

DIST. GURWITCH PRODUCTS, L.L.C, PO BOX 7568, NEW YORK, NY 10150 - ABG INT B.V. NL-VENLO MADE IN USA - www.lauramereler.com

📄 When Using This Product 11 words ▾

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER

📄 Stop Use and Ask a Doctor If 11 words ▾

STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS.

📄 Keep Out of Reach of Children 12 words ▾

KEEP OUT OF REACH OF CHILDREN. KEEP OUT OF REACH OF CHILDREN.

📄 Package Label / Principal Display Panel 114 words ▾

laura mercier flawless skin DAILY FACE SHIELD SPF 40 1 FL. OZ/30 ML

DAILY FACE SHIELD SPF 40 This weightless oil-free sunscreen goes on sheer, with no oily residue, to help shield skin from damaging sunrays and seasonal changes. Daily Face Shield SPF 40 helps: - Create an invisible shield against damaging UVA and UVB rays, preventing visible signs of aging - Formulated with Adaptogen technology which may help the skin adapt to seasonal changes. DERMATOLOGICALLY AND ALLERGY TESTED TO MINIMIZE THE RISK OF ALLERGY AND IRRITATION.

DIST. GURWITCH PRODUCTS, L.L.C, PO BOX 7568, NEW YORK, NY 10150 - ABG INT B.V. NL-VENLO MADE IN USA - www.lauramereler.com

Laura Mercier A

Laura Mercier B

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

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, TITANIUM DIOXIDE — the ingredient across all brands.

Top reported reactions

Dermatitis Contact1
Emotional Distress1
Hyperaesthesia1
Hypersensitivity1
Product Formulation Issue1
Rash1
Self Esteem Decreased1

Reporter sex

0 reports
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 Gurwitch Products, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Gurwitch Products, 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.
← 65342-1230-01 · Gurwitch 65344-0011-05 · zhejiang →
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.