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NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30 Titanium Dioxide, Zinc Oxide 2.88 mg/100mg; 6.8 mg/100mg Lotion — NDC 68577-0158-01 package photo

NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30 Titanium Dioxide, Zinc Oxide 2.88 mg/100mg; 6.8 mg/100mg Lotion

by COSMAX USA, CORPORATION · 1 TUBE in 1 CARTON (68577-158-01) / 50 mg in 1 TUBE
NDC 68577-0158-01
🏷️ FDA NDC (as labeled) 68577-158-01 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 →

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 Titanium Dioxide, Zinc Oxide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 3, 2024 — Microbial Contamination of Non-Sterile Product (Vivier Pharma, Inc.) · FDA recall D-0662-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 68577-158-01
Product NDC 68577-158
11-digit billing NDC 68577015801
UNII 15FIX9V2JP, SOI2LOH54Z
Application # M020
SPL Set ID 0d489154-6168-977e-e063-6394a90aa609
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-09-01
Route TOPICAL
Dosage form LOTION
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 68577-158-01 — 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 → 68577-0158-01. 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

LabelerCOSMAX USA, CORPORATION
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code68577
First marketedSep 2023
Product typeHuman Otc Drug
Portfolio91 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 broad-spectrum sunscreen lotion applied to the skin to help protect against ultraviolet (UV) radiation from the sun. It contains two mineral active ingredients, titanium dioxide and zinc oxide, which function as physical UV filters that work by reflecting and scattering UV rays away from the skin. This product is an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for sunscreen ingredients rather than as an individually reviewed application.

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.

🧪 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
NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30 2.88 mg/100mg; 6.8 mg/100mgthis 68577-0158-01 COSMAX 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
Sep 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68577-0158-01 You're viewing this 1 TUBE in 1 CARTON (68577-158-01) / 50 mg in 1 TUBE 2023-09-01 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 68577-158-01, 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: 68577-0158-01, written without dashes as 68577015801. 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 68577-0158-01, the first segment (68577) is the labeler code FDA assigned to COSMAX USA, CORPORATION; the middle segment (0158) 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 COSMAX USA, CORPORATION. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
COSMAX USA, CORPORATION 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 5 words ▾

USES Uses helps prevent sunburn

⏱️ Dosage and Administration 128 words ▾

DIRECTIONS Directions apply generously 15 minutes before sun exposure reapply at least every 2 hours Reapply after 40 minutes of swimming or sweating Reapply immediately after towel drying. children under 6 months of age: Ask a doctor 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 Store in a cool dry place Do not use if safety seal is broken May stain some fabric.

Protect the product in this container from excessive heat and direct sun.

⚠️ Warnings 53 words ▾

Warnings Warnings For extenal use only 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. Do not use on broken skin

🧪 Active Ingredient 8 words ▾

Active Ingredients ZInc Oxide 6.8% Titanum Dioxide 2.88%

🧪 Inactive Ingredients 147 words ▾

Inactive ingredients: Water, Isoamyl Laurate, Caprylic/ Capric Triglyceride, Butyloctyl Salicylate, Glycerin, C12-15 Alkyl Benzoate, Arachidyl Alcohol, Polyglyceryl-10 Laurate, Cetearyl Olivate, Lactobacillus Ferment, Sorbitan Olivate, Argania Spinosa (Argan) Kernel Oil, Fructose, Linum Usitatissimum (Flaxseed) Seed Oil*, Ribes Nigrum (Black Currant) Seed Oil*, Rubus Chamaemorus (Cloudberry) Seed Oil*, Withania Somnifera (Ashwagandha) Root Extract, Sambucus Nigra (Elderberry) Seed Oil*, Dipotassium Glycyrrhizate, Vaccinium Vitis-Idaea (Lingonberry) Seed Oil*, Hippophae Rhamnoides (Sea Buckthorn) Fruit Extract, Betula Alba (Birch Sap Juice) Bark Extract, Ocimum Basilicum (Basil) Oil, Tocopheryl Acetate, Lavandula Angustifolia (Lavender) Oil, Pelargonium Graveolens (Geranium) Flower Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Hydroxy[1]acetophenone, Biosaccharide Gum-4, Stearic Acid, Bisabolol, Arachidyl Glucoside, Behenyl Alcohol, Poly[1]hydroxystearic Acid, Cetyl Alcohol, Stearyl Alcohol, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Cellulose Gum, Xanthan Gum, 1,2-Hexanediol, Citric Acid, Alumina, Microcrystalline Cellulose, Styrene/Acrylates Copolymer, Potassium Sorbate, Limonene, Linalool, Citral.

🎯 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 ↗
← 68577-0157-01 · COSMAX 68577-0159-01 · COSMAX →
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.