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DERMAKA Broad Spectrum SPF-42 Sunscreen TITANIUM DIOXIDE, ZINC OXIDE 60 mg/mL; 77 mg/mL Cream, 100 mL — NDC 82240-0223-00 package photo

DERMAKA Broad Spectrum SPF-42 Sunscreen TITANIUM DIOXIDE, ZINC OXIDE 60 mg/mL; 77 mg/mL Cream, 100 mL

by DERMAKA SKIN PRODUCTS · 100 mL in 1 TUBE (82240-223-00)
NDC 82240-0223-00
🏷️ FDA NDC (as labeled) 82240-223-00 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 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) 82240-223-00
Product NDC 82240-223
11-digit billing NDC 82240022300
UNII 15FIX9V2JP, SOI2LOH54Z
Application # M020
SPL Set ID 32b892fd-c68f-4670-bbaa-0b3de5712849
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 2021-09-21
Route TOPICAL
Dosage form CREAM
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 82240-223-00 — 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 → 82240-0223-00. 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

LabelerDERMAKA SKIN PRODUCTS
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code82240
First marketedSep 2021
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?

DERMAKA Broad Spectrum SPF-42 Sunscreen is a topical cream containing titanium dioxide and zinc oxide as active ingredients. These mineral compounds function as physical UV filters, reflecting and scattering ultraviolet light away from the skin. This product is an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for sunscreen products rather than as an individually reviewed application. Titanium dioxide and zinc oxide are commonly used together in broad-spectrum sunscreens to help protect against both UVA and UVB radiation.

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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII U182GP2CF3
    Bromelain is an enzyme derived from pineapple plants that breaks down proteins. In medications, it acts as a disintegrant, helping tablets or capsules break apart and release their active ingredients more quickly in the digestive system.
  • 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 N7YC58165T
    A synthetic polymer made from glycerin and sebacic acid, used as a film-former and binder in medications. It helps hold tablet or capsule ingredients together and may coat the product for controlled release.
  • UNII E00JL9G9K0
    A plant-derived cleaning agent made from coconut oil and natural sugars. It works as a solubilizer and emulsifier to help mix water and oil-based ingredients together in the medicine.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII FGL3685T2X
    Chamomile is a plant extract used in medications as a flavoring agent and for its mild soothing properties in formulations. It helps improve taste and aroma of the medicine.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII 0N8672707O
    A starch derived from corn kernels. It acts as a binder to hold tablet ingredients together, a filler to give the tablet bulk, and a disintegrant to help the tablet break apart in your stomach.
  • UNII 11A386X1QH
    Dodecane is a clear, colorless liquid hydrocarbon derived from petroleum. It functions as a solvent and lubricant in medicines, helping dissolve active ingredients and improve how the product flows during manufacturing.
  • 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 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 B68LJT9544
    A fatty acid derivative used as a preservative and antimicrobial agent in topical medicines. It helps prevent bacterial and fungal growth to maintain product stability and safety.
  • 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 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 W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII T4V6TWG28D
    A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
  • UNII 61ZBX54883
    Licorice is a natural extract from the licorice plant root. It's used in medicines as a flavoring agent to mask bitter tastes and improve how the medicine tastes.
  • 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 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 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • 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 231473QB6R
    Watermelon is a fruit extract or flavoring agent. It's added to medicines to improve taste, making the product more palatable, especially for children or medications with unpleasant flavors.

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

The official label also statesAloe Barbadensis Leaf (Aloe Vera gel) Juice, Aqua (Deionized Water), Bromelain, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Alcohol, Chamomilla Recututa (Chamomile) Extract, Citrullus Lanatus (Watermelon) Extarct, Cocos Nucifera (Coconut) Oil, Dodecane, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extarct, Hawthorn Extract, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, Iron Oxides (Black, Red, White, Yellow), Polyhydroxystearic Acid, Sambucus Nigra (Elderberry) Extarct, Sodium Polyacrylate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

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
DERMAKA Broad Spectrum SPF-42 Sunscreen 60 mg/mL; 77 mg/mLthis 82240-0223-00 DERMAKA 100 ml — — FDA listed —
Dermaka Sunscreen SPF 42, Tinted 60 mg/mL; 77 mg/mL 82240-0619-00 DERMAKA 5 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

🏛️
2021
On the market since
Sep 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 TITANIUM DIOXIDE, ZINC OXIDE — the ingredient across all brands.

Top reported reactions

Exposure To Toxic Agent7
Product Contamination Chemical5
Acute Myeloid Leukaemia4
Malignant Melanoma4
Neoplasm Malignant4
Sunburn4
Application Site Rash3

Age at onset

Child1
Adolescent1
Adult7
Elderly2

Reporter sex

44 reports
Male · 24%
Female · 76%

Serious outcomes

Hospitalization7
Death2
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 8 1
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
82240-0223-00 You're viewing this 100 mL in 1 TUBE (82240-223-00) 2021-09-21 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 82240-223-00, 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: 82240-0223-00, written without dashes as 82240022300. 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 82240-0223-00, the first segment (82240) is the labeler code FDA assigned to DERMAKA SKIN PRODUCTS; the middle segment (0223) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 DERMAKA SKIN PRODUCTS. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
DERMAKA SKIN PRODUCTS 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 🎯 Purpose
🎯 Indications and Usage 36 words ▾

USES: Helps prevent sunburn. higher SPF gives more sunburn protection If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions

⏱️ Dosage and Administration 93 words ▾

DIRECTIONS: Apply liberally 15 minutes before sun exposure. Children under 6 months of age: ask a doctor. Reapply: afte 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Spending time in the sun increases your risk of skin cancer and early skin aging.

To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures. Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.

⚠️ Warnings 62 words ▾

WARNINGS: not intended for ingestion. 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 or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 10 words ▾

Active Ingredients Titanium dioxide 6.00% Zinc Oxide 7.70% Purpose Sunscreen

🧪 Inactive Ingredients 84 words ▾

INACTIVE INGREDIENTS: Aloe Barbadensis Leaf (Aloe Vera gel) Juice, Aqua (Deionized Water), Bromelain, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Alcohol, Chamomilla Recututa (Chamomile) Extract, Citrullus Lanatus (Watermelon) Extarct, Cocos Nucifera (Coconut) Oil, Dodecane, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extarct, Hawthorn Extract, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, Iron Oxides (Black, Red, White, Yellow), Polyhydroxystearic Acid, Sambucus Nigra (Elderberry) Extarct, Sodium Polyacrylate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

🎯 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 ↗
← 82240-0014-00 · Dermaka 82240-0424-00 · DERMAKA →
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.