![EthoSun Daily Mineral Sunscreen Broad Spectrum SPF 45 zinc oxide .19 g/[arb'U] Cream, 1 tube — NDC 85233-0000-02 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d7d2bca6-5000-4cb9-b004-b1ae286f6035&name=EthoSun+Label+-+Daily+Shimmer+%28DL%29+-+FDA+FINAL.jpg)
EthoSun Daily Mineral Sunscreen Broad Spectrum SPF 45 zinc oxide .19 g/[arb'U] Cream, 1 tube
by EthoSun, Inc · 1 TUBE in 1 TUBE (85233-0000-2) / 1 [arb'U] in 1 TUBE
NDC 85233-0000-02
🏷️ FDA NDC (as labeled)
85233-0000-2
billing pads the package 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 →
⚠️
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)
85233-0000-2
Product NDC
85233-0000
11-digit billing NDC
85233000002
UNII
SOI2LOH54Z
Application #
part352
SPL Set ID
d7d2bca6-5000-4cb9-b004-b1ae286f6035
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
2025-04-30
Route
TOPICAL
Dosage form
CREAM
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 85233-0000-2 — 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 → 85233-0000-02. 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
LabelerEthoSun, Inc
FDA applicationpart352 (OTC MONOGRAPH DRUG)
Labeler code85233
First marketedApr 2025
Product typeHuman Otc Drug
Portfolio3 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?
EthoSun Daily Mineral Sunscreen is a topical cream containing zinc oxide, an over-the-counter sunscreen active ingredient. Zinc oxide is commonly used in sunscreen products to reflect and scatter ultraviolet (UV) radiation away from the skin. This product is marketed as a broad-spectrum sunscreen with an SPF of 45, meaning it is intended to help protect against both UVA and UVB rays. It is sold as an OTC monograph drug, which means it follows FDA's established safety and effectiveness standards for sunscreen ingredients.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:
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.
💬 Questions about zinc oxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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UNII RUE8E6T4NB
Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
-
UNII C9H2L21V7U
A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
-
UNII 8D9H4QU99H
A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
-
UNII 856YO1Z64F
Turmeric is a natural spice derived from the turmeric plant root. It serves as a colorant in medicines, giving products a yellow or golden appearance, and may also provide mild flavoring.
-
UNII G3232Z5S2O
A synthetic emollient and emulsifier derived from plant oils and glycerin. It helps blend oil and water components together and gives the product a smooth texture in topical formulations.
-
UNII XPD6ZY79TB
A synthetic preservative derived from the amino acid arginine. It prevents microbial growth in medicines, helping keep the product safe and stable throughout its shelf life.
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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 UDR641JW8W
A plant-derived oil from jojoba seeds that has been broken down into smaller components. It acts as an emollient and skin-conditioning agent to help soften and smooth the product's texture.
-
UNII M1SLX00M3M
Isoamyl laurate is a synthetic ester made from isoamyl alcohol and lauric acid. It functions as an emollient and lubricant in topical formulations to help smooth and soften the skin.
-
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 1XGW49AK2J
A natural oil derived from prickly pear cactus seeds. It's used in medicines as an emollient to soften and smooth the product's texture, and sometimes as a skin-conditioning agent in topical formulations.
-
UNII XRQ165498B
A plant-derived emulsifier made from glycerin and oleic acid. It helps mix oil and water-based ingredients together in the formulation and improves product texture and stability.
-
UNII YXH47AOU0F
A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
-
UNII 18V8PAQ629
Prickly pear fruit is a natural plant extract used as a flavor and color ingredient in medicines. It adds taste and visual appeal to oral products like tablets and liquids.
-
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 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 65A9F4P024
A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
-
UNII 7QWM220FJH
Squalene is a natural oil-like substance found in shark liver and some plants. It's used in medicines as an emulsifier to help mix oil and water-based ingredients together.
-
UNII 5EHL50I4MY
A sodium salt compound used as a chelating agent in medicines. It binds to metals and minerals to improve stability, prevent discoloration, and help the medication stay effective longer.
-
UNII R0ZB2556P8
Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
-
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.
-
UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
23 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesDeionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, Glycerin*, Butyloctyl Salicylate, Isopropyl Lauroyl Sarcosinate, Lauryl Glucoside, Polyglyceryl-3 Caprate, Polyhydroxystearic Acid, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Magnesium Sulfate, Cetearyl Alcohol, Polyglyceryl-10 Oleate, Polyhydroxystearic Acid, Stearalkonium Hectorite, Sodium Chloride, Tocopherol (Vitamin E), Helianthus Annuus (Sunflower) Seed Oil*, Opuntia Ficus-Indica (Prickly Pear) Extract*, Macrocystis Pyrifera (Kelp) Extract*, Cucumis Sativus (Cucumber) Fruit Extract, Camellia Sinensis (Green Tea) Extract*, Euterpe Oleracea (Acai) Fruit Extract*, Cucurbita Pepo (Pumpkin) Seed Extract*, Sodium Dehydroacetate, Ethylhexylglycerin, Sodium Gluconate, Citric Acid, Sodium Citrate, Potassium Sorbate, Sodium Benzoate, Fragrance**, Iron Oxide (CI 77491), Mica, Titanium Dioxide *Organic Ingredients
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 system | Per g | Per 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| EthoSun Daily Mineral Sunscreen Broad Spectrum SPF 45 .19 g/[arb'U]this 85233-0000-02 | EthoSun, | 1 tube | — | — | FDA listed | — |
| EthoSun Shimmer Daily Mineral Sunscreen Broad Spectrum SPF 45 .19 g/[arb'U] 85233-0003-02 | EthoSun, | 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
🏛️
2025
On the market since
Apr 2025
📍
2026
Currently FDA-listed
1 year 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 EthoSun Daily Mineral Sunscreen Broad Spectrum SPF 45 (this brand).
Top reported reactions
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 85233-0000-02 You're viewing this | 1 TUBE in 1 TUBE (85233-0000-2) / 1 [arb'U] in 1 TUBE | 2025-04-30 | 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 85233-0000-2, 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: 85233-0000-02, written without dashes as 85233000002. 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 85233-0000-02, the first segment (85233) is the labeler code FDA assigned to EthoSun, Inc; the middle segment (0000) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 EthoSun, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
EthoSun, 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 ▾
Uses: Helps prevent sunburn.
⏱️ Dosage and Administration ▾
Directions: - Apply liberally 15 minutes before sun exposure. - Reapply: - After 80 minutes of swimming or sweating - Immediately after towel drying - At least every 2 hours - For children under 6 months of age: ask a doctor.
⚠️ Warnings ▾
Warnings: For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
🧪 Inactive Ingredients ▾
Inactive Ingredients: Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, Glycerin*, Butyloctyl Salicylate, Isopropyl Lauroyl Sarcosinate, Lauryl Glucoside, Polyglyceryl-3 Caprate, Polyhydroxystearic Acid, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Magnesium Sulfate, Cetearyl Alcohol, Polyglyceryl-10 Oleate, Polyhydroxystearic Acid, Stearalkonium Hectorite, Sodium Chloride, Tocopherol (Vitamin E), Helianthus Annuus (Sunflower) Seed Oil*, Opuntia Ficus-Indica (Prickly Pear) Extract*, Macrocystis Pyrifera (Kelp) Extract*, Cucumis Sativus (Cucumber) Fruit Extract, Camellia Sinensis (Green Tea) Extract*, Euterpe Oleracea (Acai) Fruit Extract*, Cucurbita Pepo (Pumpkin) Seed Extract*, Sodium Dehydroacetate, Ethylhexylglycerin, Sodium Gluconate, Citric Acid, Sodium Citrate, Potassium Sorbate, Sodium Benzoate, Fragrance**, Iron Oxide (CI 77491), Mica, Titanium Dioxide *Organic Ingredients
🎯 Purpose ▾
Purpose: Sunscreen
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.