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PURE SOL SPF 37 Tinted Moisturizer Zinc Oxide TITANIUM DIOXIDE 9.36 g/100mL; 3.84 g/100mL Liquid, 30 mL — NDC 84090-004-01 (Billing 84090-0004-01)

by Brand 2022b LLC · 30 mL in 1 BOTTLE

This is a package of 30 mL of PURE SOL SPF 37 Tinted Moisturizer Zinc Oxide TITANIUM DIOXIDE 9.36 g/100mL; 3.84 g/100mL Liquid from Brand 2022b LLC, marketed since Oct 2025 and currently FDA-listed. It is this product's only package size.

NDC 84090-0004-01
🏷️ FDA NDC (as labeled) 84090-004-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84090-004-01
Product NDC 84090-004
11-digit billing NDC 84090000401
UNII 15FIX9V2JP, SOI2LOH54Z
Application # M020
SPL Set ID 4052c4e4-2105-80c0-e063-6294a90af41d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-10-04
Route TOPICAL
Dosage form LIQUID
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 84090-004-01 — 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 → 84090-0004-01. 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.

Clinical

🧪 What is this product?

This is a tinted liquid moisturizer applied to the skin that contains two mineral sunscreen active ingredients: titanium dioxide and zinc oxide. These minerals are commonly used in sunscreen products to reflect and scatter ultraviolet (UV) rays away from the skin. The product is marketed as an over-the-counter drug under FDA's monograph rules for sunscreen ingredients rather than as an individually reviewed medication.

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.

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 mLPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
84090-0004-01 You're viewing this Main listing 30 mL in 1 BOTTLE 2025-10-04 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
PURE SOL SPF 37 Tinted Moisturizer 9.36 g/100mL; 3.84 g/100mLthis 84090-0004-01 Brand 30 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
Oct 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.

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 5QB0T2IUN0
    Aluminum hydroxide is a white powder mineral compound used as an antacid ingredient in some formulations. It works as a buffer and pH regulator to help neutralize stomach acid in the medicine.
  • UNII 75D21FL1PI
    A synthetic liquid derived from butylene glycol and fatty acids. It acts as an emollient and solvent to help dissolve or suspend active ingredients, improving texture and absorption in topical or oral formulations.
  • UNII 134647WMX4
    Cetyl ethylhexanoate is a synthetic oil used as an emollient and texture enhancer in medications. It helps soften the skin, improve spreadability, and provides a smooth feel to topical formulations.
  • UNII V2W71V8T0X
    A silicone-based compound that mixes oil and water together. Used in formulations as an emulsifier to help blend ingredients and improve texture and stability of creams, lotions, and other topical products.
  • UNII 035JKJ76MT
    A silicone-based ingredient that helps oil and water mix together in formulations. It works as an emulsifier to create smooth, stable textures in topical medicines and creams.
  • 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 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 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 9E4CO0W6C5
    A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
  • 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 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 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 S4V5BS6GCX
    A synthetic oily liquid used as an emollient and solvent in topical medications. It helps dissolve active ingredients and creates a smooth, spreadable texture on the skin.
  • UNII 39DK5WQ2PR
    A synthetic polymer made from methacrylate, methoxy polyethylene glycol, maleate, and styrene. It's used as a coating or binder to control how quickly the medicine dissolves and releases its active ingredients in the body.
  • UNII 8PR7V1SVM0
    A silicone-based lubricant combined with polyethylene glycol. It reduces friction and helps the medicine flow smoothly during manufacturing and improves how the product feels when applied or swallowed.
  • 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 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 8KQ7I65XZE
    A waxy compound derived from stearic acid, used as a thickener and emulsifier to help blend oil and water-based ingredients. It improves the texture and stability of the medicine formulation.
  • UNII 8D08K3S51E
    Propylene carbonate is a clear liquid solvent derived from propylene. It helps dissolve or suspend active ingredients in liquid medicines and can improve how well the product flows and mixes.
  • 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 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 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.

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

The official label also statesWATER ALUMINUM HYDROXIDE STEARIC ACID CYCLOPENTASILOXANE BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE GLYCERIN CETYL ETHYLHEXANOATE DIMETHICONE TRIETHOXYCAPRYLYLSILANE CETYL PEG/PPG-10/1 DIMETHICONE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER SILICA PEG-10 DIMETHICONE SODIUM CHLORIDE PHENOXYETHANOL ETHYLHEXYLGLYCERIN CI 77492 ISONONYL ISONONANOATE CETYL PEG/PPG-10/1 DIMETHICONE POLYHYDROXYSTEARIC ACID TRIETHOXYCAPRYLYLSILANE DISTEARDIMONIUM HECTORITE WATER CI 77491 ISONONYL ISONONANOATE DISTEARDIMONIUM HECTORITE PROPYLENE CARBONATE CI 77499 POLYHYDROXYSTEARIC ACID STYRENE/BUTADIENE COPOLYMER

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.

Manufacturer & labeler

LabelerBrand 2022b LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84090
First marketedOct 2025
Product typeHuman Otc Drug
Portfolio8 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.

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 77 words ▾

Apply liberally 15 minutes before sun exposure Reapply After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours 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 of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m.

⏱️ Dosage and Administration 21 words ▾

Apply tiberally 15 minutes before sun exposure. Reapoly. at least every 2 hours or after 40 minutes of swimming or sweating.

⚠️ Warnings 63 words ▾

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.lf swallowed, get medical help or contacta Poison Control Center right away Flammable. Do not spray near heat sparks, sources of ignition, or flames

🧪 Active Ingredient 6 words ▾

Zinc Oxide 3.84% TITANIUM DIOXIDE 9.36%

🧪 Inactive Ingredients 54 words ▾

WATER ALUMINUM HYDROXIDE STEARIC ACID CYCLOPENTASILOXANE BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE GLYCERIN CETYL ETHYLHEXANOATE DIMETHICONE TRIETHOXYCAPRYLYLSILANE CETYL PEG/PPG-10/1 DIMETHICONE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER SILICA PEG-10 DIMETHICONE SODIUM CHLORIDE PHENOXYETHANOL ETHYLHEXYLGLYCERIN CI 77492 ISONONYL ISONONANOATE CETYL PEG/PPG-10/1 DIMETHICONE POLYHYDROXYSTEARIC ACID TRIETHOXYCAPRYLYLSILANE DISTEARDIMONIUM HECTORITE WATER CI 77491 ISONONYL ISONONANOATE DISTEARDIMONIUM HECTORITE PROPYLENE CARBONATE CI 77499 POLYHYDROXYSTEARIC ACID STYRENE/BUTADIENE COPOLYMER

🎯 Purpose 12 words ▾

WATER /SWEATRESISTANT TINTED SPFMOISTURIZER Shields skin from UVA/UVBBlue Light & Infrared Rodiotion

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Zinc Oxide TITANIUM DIOXIDE — the ingredient across all brands.

Top reported reactions

Chemical Burn1
Condition Aggravated1
Dehydration1
Erythema1
Erythema Of Eyelid1
Eyelid Irritation1
Eyelid Oedema1

Reporter sex

3 reports
Female · 100%
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.

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 — Not published for this NDC No photo available yet for this listing.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Brand 2022b LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Brand 2022b 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.
← 84090-0003-01 · Brand 84090-0005-01 · Brand →
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.