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Dermatone Mineral SPF 30 Zinc Oxide 20% 20 g/100mL Lotion, 89 mL — NDC 54414-0030-02 package photo

Dermatone Mineral SPF 30 Zinc Oxide 20% 20 g/100mL Lotion, 89 mL

by Dermatone Labs LLC · 89 mL in 1 CONTAINER (54414-030-02)
NDC 54414-0030-02
🏷️ FDA NDC (as labeled) 54414-030-02 billing pads the product segment with a zero
This package
Contains89 mL Pack sizes2 compare ↓
Also comes in: 59 ml 54414-0030-03
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

🆔 Identity & classification

FDA NDC (as labeled) 54414-030-02
Product NDC 54414-030
11-digit billing NDC 54414003002
UNII SOI2LOH54Z
Application # M020
SPL Set ID 26e3209f-cb5c-484e-9b2e-74dc397d4790
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 2025-08-21
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 54414-030-02 — 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 → 54414-0030-02. 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

LabelerDermatone Labs LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code54414
First marketedAug 2025
Product typeHuman Otc Drug
Portfolio4 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?

Dermatone Mineral SPF 30 is a topical lotion containing zinc oxide, an inorganic mineral sunscreen active ingredient. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for sunscreen products rather than undergoing individual review. Zinc oxide is commonly used in sunscreens to reflect and scatter ultraviolet light away from the skin. This lotion formulation with SPF 30 is typically used to provide sun protection when applied to exposed skin.

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 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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 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 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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 4828G836N6
    A plant-derived oil mixture from coconut that acts as an emollient and solvent. It helps dissolve or carry active ingredients and improves how the medicine spreads or absorbs in topical formulations.
  • UNII 2KAG279R6R
    Dehydroacetic acid is a synthetic preservative that prevents mold, yeast, and bacterial growth in medicines. It extends shelf life by protecting the product from spoilage during storage and use.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • 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 W8K377W98I
    A mixture of sugars made by rearranging glucose molecules. It acts as a sweetener and filler to improve taste and add bulk to the medicine while helping it hold together.
  • UNII 88496G1ERL
    Sodium phytate is a plant-derived salt used in medications as a chelating agent and preservative. It helps stabilize formulations and may improve how the body absorbs certain minerals in the medicine.
  • 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 3OSQ643ZK5
    Sucrose palmitate is a manufactured ingredient made by combining sugar with palmitic acid. It acts as an emulsifier and surfactant, helping oils and water mix together smoothly in liquid or semi-solid medicines.
  • UNII 71I93STU5M
    A manufactured fat derived from sucrose and stearic acid. It acts as an emulsifier and surfactant, helping oils and water mix smoothly in formulations and improving texture and stability.
  • 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.

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

The official label also statesWATER CAPRYLIC/CAPRIC TRIGLYCERIDE COCO-CAPRYLATE BUTYLOCTYL SALICYLATE NIACINAMIDE POLYHYDROXYSTEARIC ACID GLYCERIN PANTHENOL.ALPHA.-TOCOPHEROL ACETATE SUCROSE PALMITATE XANTHAN GUM CITRIC ACID SACCHARIDE ISOMERATE SUCROSE TRISTEARATE SODIUM STEAROYL GLUTAMATE BENZYL ALCOHOL DEHYDROACETIC ACID SODIUM PHYTATE

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.
Try another pack size: 59 ml
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
EMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream 20 g/100mL 84981-0005-01 EMMA 1 jar — — FDA listed —
Hampton Sun SPF 50 Baby Mineral 20 g/100mL 87170-0017-04 S&C 94.6 ml — — FDA listed —
EMMA LEWISHAM Sunceutical SPF 50 Mineral Body Cream 20 g/100mL 84981-0003-01 EMMA 1 jar — — FDA listed —
EMMA LEWISHAM Sunceutical SPF 50 Mineral Glow Serum 20 g/100mL 84981-0002-01 EMMA 1 jar — — FDA listed —
Dermatone Mineral SPF 30 20 g/100mLthis 54414-0030-02 Dermatone 89 ml — — FDA listed —
Salt and Blue Body Sunscreen SPF 30 20 g/100mL 87822-0845-02 Salt 1 tube — — FDA listed —
The Naked Bee SPF 50 Mineral Sunscreen 20 g/100mL 82820-0003-04 The 100 ml — — 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
Aug 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 Dermatone Mineral SPF 30 (this brand).

Top reported reactions

Sepsis2
Abdominal Abscess1
Abscess1
Blood Magnesium Decreased1
Bradycardia1
Candida Infection1
Candida Test Positive1

Reporter sex

3 reports
Male · 67%
Female · 33%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1 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
54414-0030-02 You're viewing this 89 mL in 1 CONTAINER (54414-030-02) 2025-08-21 Active
54414-0030-03 59 mL in 1 CONTAINER (54414-030-03) 2025-08-21 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 54414-0030-02?
NDC 54414-0030-02 contains 89 mL — 89 ml in 1 container.
What is the difference between NDC 54414-0030-02 and NDC 54414-0030-03?
Both are Dermatone Mineral SPF 30 Zinc Oxide 20% 20 g/100mL Lotion — the drug itself is identical. NDC 54414-0030-02 is the 89 mL package, while NDC 54414-0030-03 is the 59 ml package.
What NDC number is used to bill for this package of Dermatone Mineral SPF 30 Zinc Oxide 20% 20 g/100mL Lotion?
Bill NDC 54414-0030-02 — the 11-digit billing format is 54414003002. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 54414-030-02, 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: 54414-0030-02, written without dashes as 54414003002. 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 54414-0030-02, the first segment (54414) is the labeler code FDA assigned to Dermatone Labs LLC; the middle segment (0030) 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 Dermatone Labs LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 59 ml (54414-0030-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Dermatone Labs LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients
🎯 Indications and Usage 39 words ▾

Uses • Helps prevent sunburn, higher SPF gives more sunburn protection • 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 110 words ▾

DIRECTIONS • Apply liberally 15 minutes before sun exposure. • Reapply at least every 2 hours ٠apply to all areas of the skin exposed to the sun. ٠Reapply as needed or after towel drying, swimming, or sweating. • Sun Protection Measures . Spending tme 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 of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2. p.m. • wear a long-sleeve shirt, pants, hats, and sunglasses. • children under 6 months: Ask a doctor.

⚠️ Warnings 38 words ▾

WARNINGS For external use only. When using this product : 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

🧪 Active Ingredient 7 words ▾

Active ingredients Purpose Zinc Oxide 20% Sunscreen

🧪 Inactive Ingredients 34 words ▾

Inactive Ingredeints WATER CAPRYLIC/CAPRIC TRIGLYCERIDE COCO-CAPRYLATE BUTYLOCTYL SALICYLATE NIACINAMIDE POLYHYDROXYSTEARIC ACID GLYCERIN PANTHENOL .ALPHA.-TOCOPHEROL ACETATE SUCROSE PALMITATE XANTHAN GUM CITRIC ACID SACCHARIDE ISOMERATE SUCROSE TRISTEARATE SODIUM STEAROYL GLUTAMATE BENZYL ALCOHOL DEHYDROACETIC ACID SODIUM PHYTATE

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 54414-0028-05 · Dermatone 54414-0048-01 · Dermatone →
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.