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FUSIDYNE DERMA TROUBLE Zinc Calming Sunscreen Zinc Oxide 8.463275 g/50mL Lotion — NDC 51352-0999-11 package photo

FUSIDYNE DERMA TROUBLE Zinc Calming Sunscreen Zinc Oxide 8.463275 g/50mL Lotion

by DONG WHA PHARM. CO., LTD. · 96 TUBE in 1 CARTRIDGE (51352-999-11) / 50 mL in 1 TUBE (51352-999-10)
NDC 51352-0999-11
🏷️ FDA NDC (as labeled) 51352-999-11 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) 51352-999-11
Product NDC 51352-999
11-digit billing NDC 51352099911
UNII SOI2LOH54Z
Application # M020
SPL Set ID 46457c78-74d6-ea6a-e063-6294a90a24ac
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-01
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 51352-999-11 — 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 → 51352-0999-11. 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

LabelerDONG WHA PHARM. CO., LTD.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code51352
First marketedJan 2026
Product typeHuman Otc Drug
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?

Fusidyne Derma Trouble Zinc Calming Sunscreen is a lotion applied to the skin that contains zinc oxide as its active ingredient. Zinc oxide is commonly used in over-the-counter sunscreen products to help protect the skin from ultraviolet (UV) radiation. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for sunscreen ingredients and formulations rather than having been individually reviewed for approval.

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 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 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 2EH13UN8D3
    A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
  • UNII 4MM76N4WMY
    A synthetic glass-like mineral compound containing calcium, sodium, and boron. Used as a colorant, opacifying agent, and filler in medicines to provide white color, improve appearance, and add bulk to tablets or capsules.
  • 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 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • 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 SCM4971GZQ
    A plant extract from Japanese cedar leaves used as a natural preservative and antioxidant in medicines. It helps prevent spoilage and maintains product stability during storage.
  • UNII 609A3V1SUA
    A silky liquid derived from caprylic acid that acts as an emollient and solvent in formulations. It helps dissolve active ingredients and improves the spreadability and feel of lotions, creams, and topical products.
  • UNII X687XDK09L
    A clay mineral processed to carry positive charges, used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed throughout the product.
  • 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 TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • UNII 08X4KI73EZ
    Hectorite is a clay mineral used as a thickener and suspending agent in medicines. It helps keep solid particles evenly distributed throughout liquid formulations.
  • UNII JY81OXM1OM
    A plant-based oil from coconut that has been chemically treated to solidify it. It acts as a binder and filler to help hold tablet ingredients together and give the pill its shape and firmness.
  • UNII A8289P68Y2
    Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
  • UNII DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII EG97988M5Q
    A synthetic plastic polymer that forms a three-dimensional network. It's used as a coating on tablets and capsules to control how fast the medicine releases into the body, or as a binder to hold pill ingredients together.
  • UNII 60C608DPVT
    A plant extract from lotus leaves used as a natural ingredient in formulations. It may serve as an antioxidant, preservative, or botanical additive to support product stability and shelf life.
  • UNII 40KQ7Q535O
    A plant extract from white water lily flowers. It's used in formulations for its soothing and skin-conditioning properties, often included in topical products as a natural ingredient to enhance texture and feel.
  • UNII 9229XJ4V12
    A synthetic emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients in formulations, keeping them mixed and preventing separation.
  • UNII 7B8OE71MQC
    A synthetic emulsifier derived from glycerin and fatty acids. It helps oils and water mix together in formulations, keeping ingredients evenly distributed throughout the product.
  • UNII YPM0ZOC2HR
    A synthetic emulsifier derived from glycerin and castor oil. It helps mix oil and water-based ingredients together in the formulation to create a uniform product and improve texture.
  • 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 991Z19V2OD
    Propylheptyl caprylate is a synthetic oily liquid made from fatty acids. It's used in medicines as an emollient and solvent to help dissolve active ingredients and improve how the product spreads or absorbs.
  • 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 01S2G2C1E4
    Sorbitan isostearate is an emulsifier derived from sorbitol and isostearic acid. It helps mix oil and water-based ingredients together and keeps them blended throughout the medicine's shelf life.
  • 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 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.

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

The official label also statesInactive ingredients Water, Butyloctyl Salicylate, Propyheptyl Caprylate, Propanediol, Hydrogenated Coco nut Oil, Isodadecane, Caprylic/Capric Triglyceride, Glycerin, Dicaprylyl Carbonate, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, Fusidium Coccineum Ferment Lysate Extract Filtrate, Nymphaea Alba Flower Extract, Protease, Nelum bo Nicifera Leaf Extract, Sacccharomyces Ferment, Crypto meria Japonica Leaf Extract, Methyl Methacrylate Crosspolymer, Disteardimonium Hectorite, Calcium Sodium Borosilicate, Triethoxycaprylylsilane, Polyglyceryl-2 Isostearate, 1,2-Hexanediol, Polyglyceryl-2 Dipolyhydroxystearate, Coco-Caprylate/Caprate, Caprylyl Glycol, Glyceryl Caprylate, Sorbitan Isostearate, Hectorite, Magnesium Sulfate, Butylene Glycol, Tocopherol

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
FUSIDYNE DERMA TROUBLE Zinc Calming Sunscreen 8.463275 g/50mLthis 51352-0999-11 DONG 96 tubes — — 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
Jan 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
51352-0999-11 You're viewing this 96 TUBE in 1 CARTRIDGE (51352-999-11) / 50 mL in 1 TUBE (51352-999-10) 2026-01-01 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) ✓ 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 51352-999-11, 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: 51352-0999-11, written without dashes as 51352099911. 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 51352-0999-11, the first segment (51352) is the labeler code FDA assigned to DONG WHA PHARM. CO., LTD.; the middle segment (0999) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) 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 DONG WHA PHARM. CO., LTD.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
DONG WHA PHARM. CO., LTD. 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 28 words ▾

USES helps prevent sunburn if used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun 3

⏱️ Dosage and Administration 43 words ▾

Directions Directions apply generously and evenly 15 minutes before sun exposure. apply to all skin exposed to the sun. reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating.children under 6 months of age: ask a doctor. 8

⚠️ Warnings 120 words ▾

Warning 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. 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 4

📦 Storage and Handling 17 words ▾

Other information Other information protect the product in this container from excessive heat and direct sun 9

🧪 Active Ingredient 5 words ▾

Active Ingredients-Zinc Oxide 16.9% 1

🧪 Inactive Ingredients 75 words ▾

Inactive Ingredients Inactive ingredients Water, Butyloctyl Salicylate, Propyheptyl Caprylate, Propanediol, Hydrogenated Coco nut Oil, Isodadecane, Caprylic/Capric Triglyceride, Glycerin, Dicaprylyl Carbonate, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, Fusidium Coccineum Ferment Lysate Extract Filtrate, Nymphaea Alba Flower Extract, Protease, Nelum bo Nicifera Leaf Extract, Sacccharomyces Ferment, Crypto meria Japonica Leaf Extract, Methyl Methacrylate Crosspolymer, Disteardimonium Hectorite, Calcium Sodium Borosilicate, Triethoxycaprylylsilane, Polyglyceryl-2 Isostearate, 1,2-Hexanediol, Polyglyceryl-2 Dipolyhydroxystearate, Coco-Caprylate/Caprate, Caprylyl Glycol, Glyceryl Caprylate, Sorbitan Isostearate, Hectorite, Magnesium Sulfate, Butylene Glycol, Tocopherol 10

🎯 Purpose 3 words ▾

Purpose-Sunscreen Purpose-​Sunscreen 2

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51352-0189-73 · DONGWHA 51364-0007-00 · Synthesia, →
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.