Home › NDC Lookup › Ingredients › Zinc Oxide, Octinoxate › 83286-0015-01
MATTE UNIVERSAL TINTED MOISTURIZER SPF46 Zinc Oxide, Octinoxate 12 g/100mL; 7.5 g/100mL Cream, 50 mL — NDC 83286-0015-01 package photo

MATTE UNIVERSAL TINTED MOISTURIZER SPF46 Zinc Oxide, Octinoxate 12 g/100mL; 7.5 g/100mL Cream, 50 mL

by Drmtlgy, LLC · 50 mL in 1 BOTTLE (83286-015-01)
NDC 83286-0015-01
🏷️ FDA NDC (as labeled) 83286-015-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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) 83286-015-01
Product NDC 83286-015
11-digit billing NDC 83286001501
UNII SOI2LOH54Z, 4Y5P7MUD51
Application # M020
SPL Set ID 8e284afd-b90f-41d5-b334-e5cf4440b4d3
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 2025-01-01
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE; OCTINOXATE
Why two NDCs? The FDA registers this code as 83286-015-01 — 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 → 83286-0015-01. 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

LabelerDrmtlgy, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code83286
First marketedJan 2025
Product typeHuman Otc Drug
Portfolio18 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 topical cream marketed as a tinted moisturizer with sun protection, containing two active ingredients commonly used as ultraviolet (UV) filters in sunscreen products. Zinc oxide and octinoxate function as inorganic and organic UV blockers, respectively, and are typically included in over-the-counter sunscreen formulas to help protect skin from sun exposure. This product is an OTC monograph drug, meaning it is marketed under FDA's established rule-book for sunscreen products rather than as an individually approved application.

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 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 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 YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII 86FQE96TZ4
    A synthetic polymer, this ingredient acts as a thickener and suspending agent in liquid formulations. It helps maintain uniform consistency and keeps particles evenly distributed throughout the medicine.
  • UNII 113171Q70B
    Lauroyl lysine is a compound made by combining an amino acid (lysine) with a fatty acid (lauric acid). It works as a glidant and lubricant to help powder particles flow smoothly during manufacturing and tablet compression.
  • 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 X8725R883T
    A synthetic oily liquid derived from branched carboxylic acids, used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product's texture while improving how it spreads on skin.
  • UNII 8Q0Z18J1VL
    A surfactant derived from oleic acid, a naturally occurring fatty acid. It helps mix oil and water-based ingredients together in formulations, improving product stability and texture.
  • UNII MVJ3AD73GG
    A synthetic liquid derived from coconut oil and polyethylene glycol, used as an emulsifier and solubilizer to help mix water and oil-based ingredients and improve how the medicine dissolves and spreads throughout the formulation.
  • 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 RLA2U05Z4Q
    A silicone-based compound that acts as an emulsifier and skin-conditioning agent in topical formulations. It helps blend oil and water components together and creates a smooth, protective texture on the skin's surface.
  • UNII ZCD6009IUF
    A plant-derived ingredient from knotweed used as a natural filler and binding agent. It helps hold the medicine's ingredients together and add bulk to tablets or capsules.
  • UNII DSQ2V1DD1K
    A synthetic rubber polymer used as a binder and viscosity agent in medicines. It helps hold tablet ingredients together and controls how quickly the medicine dissolves or releases in the body.
  • UNII R85W246Z1C
    A yeast-derived substance made from broken-down Saccharomyces cerevisiae cells. It is used as a natural humectant and moisturizing agent to help keep medicines and supplements stable and prevent them from drying out.
  • 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 X75PL53TZJ
    A silicone-based polymer that functions as a glidant and anti-caking agent, helping the medicine powder flow smoothly during manufacturing and preventing clumping in the final product.
  • 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.

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

The official label also statesWater/Aqua/Eau, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane Crosspolymer, Octyldodecyl Neopentanoate, Saccharomyces Ferment, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glycerin, Knotweed (Polygonum Aviculare) Extract, Sodium Hyaluronate, Tocopheryl Acetate, Ethylhexylglycerin, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, PEG-7 Trimethylolpropane Coconut Ether, Lauroyl Lysine, Polyisobutene, Triethoxycaprylylsilane, Disodium EDTA, Iron Oxide (CI 77492), Iron Oxide (CI 77491), Iron Oxide (CI 77499), 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
Broad Spectrum SPF45 12 g/100mL; 7.5 g/100mL 83286-0014-01 Drmtlgy, 50 ml — — FDA listed —
Tinted Moisturizer SPF 46 Universal Tint 12 g/100mL; 7.5 g/100mL 83286-0009-01 Drmtlgy, 50 ml — — FDA listed —
Matte Universal Tinted Moisturizer Spf46 12 g/100mL; 7.5 g/100mLthis 83286-0015-01 Drmtlgy, 50 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
Jan 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
83286-0015-01 You're viewing this 50 mL in 1 BOTTLE (83286-015-01) 2025-01-01 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 83286-015-01, 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: 83286-0015-01, written without dashes as 83286001501. 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 83286-0015-01, the first segment (83286) is the labeler code FDA assigned to Drmtlgy, LLC; the middle segment (0015) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Drmtlgy, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Drmtlgy, 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 🎯 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.

⏱️ Dosage and Administration 31 words ▾

Directions • Apply to face and neck, avoiding the eye area. Wait at least 30 minutes before sun exposure, or as directed by a physician. Reapply at least every 2 hours.

⚠️ Warnings 46 words ▾

Warnings For external use only. When using this product • keep out of eyes. Rinse with water to remove. Stop use and ask physician 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 Zinc Oxide 12% Octinoxate 7.5%

🧪 Inactive Ingredients 61 words ▾

Inactive Ingredients Water/Aqua/Eau, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane Crosspolymer, Octyldodecyl Neopentanoate, Saccharomyces Ferment, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glycerin, Knotweed (Polygonum Aviculare) Extract, Sodium Hyaluronate, Tocopheryl Acetate, Ethylhexylglycerin, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, PEG-7 Trimethylolpropane Coconut Ether, Lauroyl Lysine, Polyisobutene, Triethoxycaprylylsilane, Disodium EDTA, Iron Oxide (CI 77492), Iron Oxide (CI 77491), Iron Oxide (CI 77499), 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 ↗
← 83286-0014-01 · Drmtlgy, 83286-0016-01 · Drmtlgy, →
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.