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ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 Zinc Oxide .675 mg/2.7g Powder, 1 jar — NDC 42851-0068-27 package photo

ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 Zinc Oxide .675 mg/2.7g Powder, 1 jar

by ZO Skin Health, Inc. · 1 JAR in 1 CARTON (42851-068-27) / 2.7 g in 1 JAR
NDC 42851-0068-27
🏷️ FDA NDC (as labeled) 42851-068-27 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) 42851-068-27
Product NDC 42851-068
11-digit billing NDC 42851006827
UNII SOI2LOH54Z
Application # M020
SPL Set ID be3c7ef2-dd08-0f1a-e053-2995a90ae14c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-02-09
Route TOPICAL
Dosage form POWDER
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 42851-068-27 — 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 → 42851-0068-27. 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 marketedFeb 2021
Product typeHuman Otc Drug
Portfolio23 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 powder sunscreen marketed under FDA's over-the-counter monograph rules. It contains zinc oxide, a mineral active ingredient that works by sitting on the skin's surface to reflect and scatter ultraviolet light. The product is applied topically and is labeled as broad-spectrum SPF 45, meaning it is intended to help protect skin from both UVA and UVB sun exposure. Powder sunscreens like this one are commonly used for touch-ups or as an alternative to liquid 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.

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

  • 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 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 789U1901C5
    Bronze powder is a metallic mixture of copper and tin. It's used as a colorant in some medications to create a distinctive appearance and help identify the product.
  • UNII 5B8915UELW
    A plant-derived compound used as an antioxidant in medicines. It helps prevent spoilage and degradation of active ingredients during storage by protecting them from oxidative damage.
  • 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 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 XIA46H803R
    Jojoba butter is a waxy plant oil derived from jojoba seeds. It's used in medicines as an emollient and texture agent to soften the product and improve how it feels on skin or in the mouth.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • 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 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 Z47NNT4J11
    A synthetic plastic polymer used as a film-coating material on tablets and capsules. It helps protect the medicine, control how fast it dissolves, and improve appearance by creating a smooth, glossy outer layer.
  • 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 91D9GV0Z28
    A mineral salt made from calcium and phosphate. It acts as a filler to add bulk to the tablet or capsule, and helps bind ingredients together so the medicine holds its shape.
  • 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 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.

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

The official label also statesMica, Hydroxyapatite, Polymethyl Methacrylate, HDI/Trimethylol Hexyllactone Crosspolymer, Simmondsia Chinensis (Jojoba) Butter, Bronze Powder, Simmondsia Chinensis (Jojoba) Seed Oil, Iron Oxides, Triethoxycaprylylsilane, Bisabolol, Ethyl Ferulate, Ethylhexylglycerin, Melanin, Pentylene Glycol, Water, Silica, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Phenoxyethanol.

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
Sunscreen Plus Powder Broad-Spectrum SPF 45 .675 mg/2.7g 42851-0069-27 ZO 1 jar — — FDA listed —
ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 .675 mg/2.7gthis 42851-0068-27 ZO 1 jar — — 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

🏛️
2021
On the market since
Feb 2021
📍
2026
Currently FDA-listed
5 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 Zinc Oxide — the ingredient across all brands.

Top reported reactions

Macular Degeneration460
Nausea365
Pyrexia351
Pain348
Malaise289
Weight Decreased284
Constipation257

Reporter sex

0 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Death290
Life-threatening166
Disabling63
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 365 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
42851-0068-27 You're viewing this 1 JAR in 1 CARTON (42851-068-27) / 2.7 g in 1 JAR 2021-02-09 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 42851-068-27, 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: 42851-0068-27, written without dashes as 42851006827. 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 42851-0068-27, the first segment (42851) is the labeler code FDA assigned to ZO Skin Health, Inc.; the middle segment (0068) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (27) 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 135 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

Directions Apply liberally 15 minutes before sun exposure Reapply: at least every 2 hours Use a water-resistant sunscreen if swimming or sweating 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.

⏱️ Dosage and Administration ~1 min read ▾

Drug Facts Active Ingredients Active Ingredents Purpose Zinc Oxide 25.0% Sunscreen Purpose Sunscreen 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 Warnings For external use only. Do not use on damaged or broken skin. 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. Directions Apply liberally 15 minutes before sun exposure Reapply: at least every 2 hours Use a water-resistant sunscreen if swimming or sweating 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. Other Information Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. Protect the product in this container from excessive heat and direct sun.

You may report a serious adverse reaction to: 9685 Research Dr., Irvine, CA 92618 Inactive Ingredients Mica, Hydroxyapatite, Polymethyl Methacrylate, HDI/Trimethylol Hexyllactone Crosspolymer, Simmondsia Chinensis (Jojoba) Butter, Bronze Powder, Simmondsia Chinensis (Jojoba) Seed Oil, Iron Oxides, Triethoxycaprylylsilane, Bisabolol, Ethyl Ferulate, Ethylhexylglycerin, Melanin, Pentylene Glycol, Water, Silica, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Phenoxyethanol.

⚠️ Warnings 54 words ▾

Warnings For external use only. Do not use on damaged or broken skin. 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.

📦 Storage and Handling 12 words ▾

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

🧪 Active Ingredient 9 words ▾

Active Ingredients Active Ingredents Purpose Zinc Oxide 25.0% Sunscreen

🧪 Inactive Ingredients 39 words ▾

Inactive Ingredients Mica, Hydroxyapatite, Polymethyl Methacrylate, HDI/Trimethylol Hexyllactone Crosspolymer, Simmondsia Chinensis (Jojoba) Butter, Bronze Powder, Simmondsia Chinensis (Jojoba) Seed Oil, Iron Oxides, Triethoxycaprylylsilane, Bisabolol, Ethyl Ferulate, Ethylhexylglycerin, Melanin, Pentylene Glycol, Water, Silica, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Phenoxyethanol.

🎯 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 ↗
← 42851-0064-04 · ZO 42851-0069-27 · 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.