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ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light Medium) Titanium Dioxide, Zinc Oxide 132 mg/mL; 54 mg/mL Lotion — NDC 42851-0203-45 package photo

ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light Medium) Titanium Dioxide, Zinc Oxide 132 mg/mL; 54 mg/mL Lotion

by ZO Skin Health Inc. · 1 TUBE in 1 CARTON (42851-203-45) / 45 mL in 1 TUBE
NDC 42851-0203-45
🏷️ FDA NDC (as labeled) 42851-203-45 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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) 42851-203-45
Product NDC 42851-203
11-digit billing NDC 42851020345
UNII SOI2LOH54Z, 15FIX9V2JP
Application # M020
SPL Set ID 4f87e24f-e4ff-03a7-e063-6294a90a23b1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-15
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 42851-203-45 — 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 → 42851-0203-45. 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

LabelerZO Skin Health Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code42851
First marketedApr 2026
Product typeHuman Otc Drug
Portfolio6 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 lotion applied to the skin that functions as a broad-spectrum sunscreen with an SPF of 45. The active ingredients, zinc oxide and titanium dioxide, are mineral-based UV filters commonly used to help block and scatter ultraviolet radiation from the sun. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established safety and effectiveness standards for sunscreen products in this category.

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.

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

  • UNII TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII SQI2NBY9KR
    A plant-derived material from alfalfa used as a natural colorant and nutritional filler in medications. It may add green color and bulk to tablets or capsules.
  • 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 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 PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • 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 035JKJ76MT
    A silicone-based ingredient that helps oil and water mix together in formulations. It works as an emulsifier to create smooth, stable textures in topical medicines and creams.
  • 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 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 UF7620L1W6
    A synthetic silicone polymer that acts as a thickener and absorbent in medicines. It helps create the right texture, improves how the product feels on skin or in the mouth, and can absorb excess moisture or oil in formulations.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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 42B5YD8F0K
    A plant extract from licorice root used in traditional medicine. In formulations, it may serve as a flavoring agent, sweetener, or soothing ingredient to improve taste and texture.
  • UNII 4CG9F9W01Q
    A synthetic fatty acid ester used as an emollient and skin-conditioning agent in topical medicines. It helps soften the product texture and improves how it spreads and absorbs into the skin.
  • UNII 2C1F12C6AP
    A beneficial live bacterium used as a probiotic ingredient. It's included to support the product's probiotic function by promoting beneficial microorganisms in the digestive system.
  • UNII O0CV1RMR44
    A dark pigment made synthetically from tyrosine and peroxide. It's used as a colorant in tablets and capsules to give medicines their color and help distinguish different dosages visually.
  • 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 287GF3Y3WC
    PEG-10 Dimethicone is a silicone-based compound that acts as an emulsifier and surfactant in medicines. It helps blend water and oil-based ingredients together and reduces surface tension to improve how the product spreads and feels.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • 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 ZA983U4810
    A blue-green algae extract used as a natural colorant to give medicines their blue or green tint. It provides color to tablets and capsules without adding therapeutic ingredients.
  • UNII 820DPX33S7
    A synthetic emulsifier derived from glycerin and fatty acids. It helps mix oil and water-based ingredients together and keeps them evenly blended throughout the product.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII 1D1K0N0VVC
    A fat-soluble form of vitamin A used as a colorant and nutritional fortification ingredient. It gives products a yellow or orange tint and increases vitamin A content in the formula.
  • UNII 7F763NNC9X
    Schizophyllan is a polysaccharide derived from a fungus. It's used as a binder and thickening agent to help hold tablet ingredients together and improve the texture of medicines.
  • UNII 7J95K7ID2S
    A plant extract from the roots of Chinese skullcap, used as a natural coloring agent and to add mild flavor to medicines. It may also help preserve the product's stability.
  • 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 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • 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 KM7N50LOS6
    Tin oxide is an inorganic mineral compound used in medicines as a colorant and opacifying agent. It provides white or off-white color to tablets, capsules, and coatings while helping make formulations less transparent.
  • 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 LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • 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.

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

The official label also statesDimethicone, Water, Squalane, PEG-10 Dimethicone, Propanediol, Glycerin, Tribehenin, Dimethicone Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Hexyl Laurate, Polyglyceryl-4 Isostearate, Titanium Dioxide, Bisabolol, Lactobacillus Ferment, Scutellaria Baicalensis Root Extract, Cordyceps Militaris Mycelium Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Tocopheryl Acetate, Medicago Sativa (Alfalfa) Extract, Phormidium Persicinum Extract, Lecithin, Phenoxyethanol, Plankton Extract, Beta-Glucan, Stearic Acid, Microcrystalline Cellulose, Alumina, Butylene Glycol, Sea Water, Sodium Chloride, Sodium Citrate, Mica, Triethoxycaprylylsilane, Melanin, Pentylene Glycol, Ascorbic Acid, 1,2-Hexanediol, Ethylhexylglycerin, Tin Oxide, Retinyl Palmitate, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492, CI 77491, CI77499).

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.

💲 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
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light) 132 mg/mL; 54 mg/mL 42851-0202-45 ZO 1 tube — — FDA listed —
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light Medium) 132 mg/mL; 54 mg/mLthis 42851-0203-45 ZO 1 tube — — FDA listed —
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Deep) 132 mg/mL; 54 mg/mL 42851-0206-45 ZO 1 tube — — FDA listed —
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 132 mg/mL; 54 mg/mL 42851-0201-45 ZO 1 tube — — FDA listed —
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Medium) 132 mg/mL; 54 mg/mL 42851-0204-45 ZO 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

🏛️
2026
On the market since
Apr 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
42851-0203-45 You're viewing this 1 TUBE in 1 CARTON (42851-203-45) / 45 mL in 1 TUBE 2026-04-15 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 42851-203-45, 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: 42851-0203-45, written without dashes as 42851020345. 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 42851-0203-45, the first segment (42851) is the labeler code FDA assigned to ZO Skin Health Inc.; the middle segment (0203) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (45) 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 ZO Skin Health Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ZO Skin Health 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 ⏱️ Dosage and Administration ⚠️ Warnings and Cautions ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 44 words ▾

Uses ■ helps prevent sunburn ■ higher SPF gives more sunburn protection ■ provides high protection against 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 ■ Apply liberally 15 minutes before sun exposure and as needed. ■ Use a water-resistant sunscreen if swimming or sweating ■ Reapply: ■ at least every 2 hours ■ 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

⚠️ Warnings and Cautions 9 words ▾

Warnings For external use only. For external use only.

⚠️ Warnings 4 words ▾

For external use only.

🧪 Active Ingredient 10 words ▾

Drug Facts Active Ingredients Titanium Dioxide 5.4% Zinc Oxide 13.2%

🧪 Inactive Ingredients 87 words ▾

Dimethicone, Water, Squalane, PEG-10 Dimethicone, Propanediol, Glycerin, Tribehenin, Dimethicone Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Hexyl Laurate, Polyglyceryl-4 Isostearate, Titanium Dioxide, Bisabolol, Lactobacillus Ferment, Scutellaria Baicalensis Root Extract, Cordyceps Militaris Mycelium Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Tocopheryl Acetate, Medicago Sativa (Alfalfa) Extract, Phormidium Persicinum Extract, Lecithin, Phenoxyethanol, Plankton Extract, Beta-Glucan, Stearic Acid, Microcrystalline Cellulose, Alumina, Butylene Glycol, Sea Water, Sodium Chloride, Sodium Citrate, Mica, Triethoxycaprylylsilane, Melanin, Pentylene Glycol, Ascorbic Acid, 1,2-Hexanediol, Ethylhexylglycerin, Tin Oxide, Retinyl Palmitate, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492, CI 77491, CI77499).

🎯 Purpose 2 words ▾

Propose Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 42851-0202-45 · ZO 42851-0204-45 · ZO →
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.