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NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT TAN ZINC OXIDE 15 g/100mL Lotion — NDC 54111-0168-50 package photo

NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT TAN ZINC OXIDE 15 g/100mL Lotion

by Bentley Laboratories, LLC · 1 TUBE in 1 CARTON (54111-168-50) / 50 mL in 1 TUBE
NDC 54111-0168-50
🏷️ FDA NDC (as labeled) 54111-168-50 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 54111-168-50
Product NDC 54111-168
11-digit billing NDC 54111016850
UNII SOI2LOH54Z
Application # M016
SPL Set ID 7920708a-6fa7-4bc8-94ba-096e77d9d7e1
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-02-12
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 54111-168-50 — 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 → 54111-0168-50. 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

LabelerBentley Laboratories, LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code54111
First marketedFeb 2023
Product typeHuman Otc Drug
Portfolio35 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 daily mineral sunscreen lotion applied to the skin. It contains zinc oxide, a mineral UV filter that functions as a sunscreen by reflecting and scattering ultraviolet rays away from the skin. Zinc oxide is commonly used in broad-spectrum sunscreen products to help protect exposed skin from sun damage. This product is an over-the-counter monograph drug, meaning it is regulated under the FDA's established rules for sunscreen ingredients and formulations.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Zinc oxide (OTC drug) (3 interactions) — ranked by severity →
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 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.
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
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 08 Chestnut 15 g/100mL 85282-0103-01 Power 1 tube — — FDA listed —
ZOEY NATURALS DIAPER Cream 15 g/100mL 70793-0010-34 Absolutely 1 tube — — FDA listed —
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 24 Ecru, Ochre 15 g/100mL 85282-0111-01 Power 1 tube — — FDA listed —
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 20 Palomino, Sand 15 g/100mL 85282-0109-01 Power 1 tube — — FDA listed —
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 22 Oak, Bisque 15 g/100mL 85282-0110-01 Power 1 tube — — FDA listed —
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 26 Dune, Sandstone 15 g/100mL 85282-0112-01 Power 1 tube — — FDA listed —
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 02 Umber, Bistre 15 g/100mL 85282-0100-01 Power 1 tube — — FDA listed —
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 12 Buff, Calico 15 g/100mL 85282-0105-01 Power 1 tube — — FDA listed —
Block Party SPF-50 15 g/100mL 85753-0102-01 Cove 89 ml — — FDA listed —
Nudescreen Lip Primer Spf 30 - Natural Tint 15 g/100mL 54111-0166-50 Bentley 1 tube — — FDA listed —
Nudescreen Daily Mineral Veil Spf 30 - Tint Nude 15 g/100mL 54111-0167-50 Bentley 1 tube — — FDA listed —
Nudescreen Daily Mineral Veil Spf 30 - Tint Tan 15 g/100mLthis 54111-0168-50 Bentley 1 tube — — FDA listed —
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 10 Amber, Sienna 15 g/100mL 85282-0104-01 Power 1 tube — — FDA listed —
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 14 Burlwood 15 g/100mL 85282-0106-01 Power 1 tube — — FDA listed —
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 30 Ceramic, Bone 15 g/100mL 85282-0114-01 Power 1 tube — — FDA listed —
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 16 Suede, Jute 15 g/100mL 85282-0107-01 Power 1 tube — — FDA listed —
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 28 Silk, Chiffon, Cream, Linen 15 g/100mL 85282-0113-01 Power 1 tube — — FDA listed —
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 06 Tiger Eye, Taurillon 15 g/100mL 85282-0102-01 Power 1 tube — — FDA listed —
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 04 Sepia, Cacao 15 g/100mL 85282-0101-01 Power 1 tube — — FDA listed —
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 18 Camel, Khaki 15 g/100mL 85282-0108-01 Power 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

🏛️
2023
On the market since
Feb 2023
📍
2026
Currently FDA-listed
3 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.

🔬 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 NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT TAN (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Age at onset

Neonate5
Infant8
Child28
Adolescent5
Adult110
Elderly192

Reporter sex

1,941 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization988
Death204
Disabling32
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 272 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
54111-0168-50 You're viewing this 1 TUBE in 1 CARTON (54111-168-50) / 50 mL in 1 TUBE 2023-02-12 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 54111-168-50, 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: 54111-0168-50, written without dashes as 54111016850. 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 54111-0168-50, the first segment (54111) is the labeler code FDA assigned to Bentley Laboratories, LLC; the middle segment (0168) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) 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 Bentley Laboratories, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bentley Laboratories, 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.

📄 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
🎯 Indications and Usage 116 words ▾

Uses / Usages • Sun Protection Factor 30 • Sunscreen • Helps prevent sunburn • Broad Spectrum (SPF 30) • UVA/UVB Protection • 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./ • Facteur de protection solaire 30 • Crème solaire • Aide à prévenir les coups de soleil • F.P.S. 30 à Large spectre • Protection UVA/UVB • Sile produit est utilisé selon les instructions et avec d’autres mesures de protection contre le soleil [voir les Mode d’emploi], le risque de cancer de la peau et de vieillissement prématuré de la peau causé par le soleil est réduit.

⏱️ Dosage and Administration ~1 min read ▾

Directions / Mode d’emploi • Adults and children over 6 months. • Apply generously and evenly 15 minutes before sun exposure. • Reapply at least every 2 hours. / • Adultes et enfants de plus de 6 mois • Appliquer abondamment/généreusement (et uniformément) 15 minutes avant l’exposition au soleil • Appliquer de nouveau au moins toutes les 2 heures • 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. / 11 a.m. – 3 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses • Test on a small area of skin before first use.

If irritation occurs (within 24 hours), use a different product • Use a water-resistant sunscreen if swimming or sweating • Children under 6 months of age: ask a doctor / Mesures de protection solaire: Passer du temps au soleil augmente le risque de cancer de la peau et du vieillissement prématuré de la peau. Afin de diminuer ce risque, il convient d’utiliser régulièrement un écran solaire avec un F.P.S. à large spectre d’au moins 15 et d’appliquer d’autres mesures de protection contre le soleil, telles que: limiter le temps passé au soleil, notamment entre 10h - 14h / 11h - 15h • Porter des chemises à manches longues, des pantalons, un chapeau et des lunettes de soleil. • Avant d’utiliser, appliquer sur une petite surface de la peau.

Si une irritation se produit (dans un délai de 24 heures), utiliser une autre produit que celui-ci. • Utiliser un écran solaire résistant à l’eau lors d’une activité aquatique ou s’il y a transpiration. • Enfants de moins de 6 mois: consulter un médecin

⚠️ Warnings 68 words ▾

For external use only / Pour usage externe seulement When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. / Lorsque vous utilisez ce produit éviter tout contact avec les yeux. Le cas échéant, bien rincer avec les yeux.. Stop use and consult a health care practitioner if rash occurs. /Arrêter l’utilisation et consultez un professionnel de la santé en cas d’éruption cutanée

🧪 Active Ingredient 19 words ▾

Drug Facts / Info-Médicament Active ingredient (w/w) / Ingrédient actif (p/p) Zinc Oxide 15% / Oxyde de Zinc 15%

🧪 Inactive Ingredients 73 words ▾

Inactive ingredients / Ingrédients inactifs Aqua/Water/Eau, Coconut Alkanes, Caprylic/Capric Triglyceride, Propanediol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Coco-Caprylate/Caprate, Methyl Dihydroabietate, Spirulina Platensis Extract, C13-15 Alkane, Octyldodecanol, Sodium Chloride, Distarch Phosphate, Iron Oxides (CI 77492), Polyhydroxystearic Acid, Isostearic Acid, Quaternium-90 Bentonite, Hydroxyacetophenone, Benzyl Alcohol, 1,2-Hexanediol, Zinc Stearate, Ethyl Ferulate, Iron Oxides (CI 77491), Butylene Glycol, Triethyl Citrate, Iron Oxides (CI 77499), Mica, Lactobacillus Ferment, Passiflora Edulis Fruit Extract, Titanium Dioxide (CI 77891), Sorbitan Oleate, Camellia Sinensis Leaf Extract

🎯 Purpose 8 words ▾

Purpose / Utilite Sun Protectant / Écran solaire

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 54111-0167-50 · Bentley 54111-0169-50 · Bentley →
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.