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Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen Titanium Dioxide and Zinc Oxide 81 mg/g; 60 mg/g Stick — NDC 49358-0578-01 package photo

Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen Titanium Dioxide and Zinc Oxide 81 mg/g; 60 mg/g Stick

by MDSolarSciences · 1 TUBE in 1 CARTON (49358-578-01) / 17 g in 1 TUBE
NDC 49358-0578-01
🏷️ FDA NDC (as labeled) 49358-578-01 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

🆔 Identity & classification

FDA NDC (as labeled) 49358-578-01
Product NDC 49358-578
11-digit billing NDC 49358057801
UNII 15FIX9V2JP, SOI2LOH54Z
Application # M020
SPL Set ID b8f08778-7e5e-4341-9a24-1ce57c6525c7
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-07-01
Route TOPICAL
Dosage form STICK
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 49358-578-01 — 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 → 49358-0578-01. 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

LabelerMDSolarSciences
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code49358
First marketedJul 2023
Product typeHuman Otc Drug
Portfolio27 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?

Solar Stick Tinted SPF 40 is a topical mineral sunscreen in stick form, marketed as an over-the-counter monograph product. It contains titanium dioxide and zinc oxide, two mineral UV filters that work by reflecting and scattering ultraviolet light away from the skin. This product is typically used to help protect skin from sun damage and is labeled water-resistant for up to 80 minutes. The tinted formulation is designed to provide broad-spectrum protection (against both UVA and UVB rays) with an SPF rating of 40.

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 S7ZA3CCJ4M
    A synthetic polymer made from acrylic compounds and silicone, this substance forms a flexible protective coating on tablet or capsule surfaces. It helps control medicine release into your body and protects the active ingredient from moisture and air.
  • UNII A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • 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 NGS1GGK4GW
    A plant-derived emollient and emulsifier made from olive oil and behenic acid. It helps blend oil and water ingredients together in formulations and provides a smooth texture.
  • UNII 75HIF3C97L
    A synthetic organic compound used as a colorant and light-stabilizing agent in medications. It helps protect the drug formulation from fading or degrading when exposed to light.
  • 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 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 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 HYE7O27HAO
    Glyceryl isostearate is a fatty substance derived from vegetable oils or animal fats. In medicines, it acts as an emulsifier to blend water and oil components together, and helps form a smooth texture in creams, ointments, and other topical products.
  • UNII UG00KM4WR7
    A plastic polymer used as a container material and film coating. It helps protect the medicine from moisture and air exposure during storage and shipping.
  • 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 7666FJ0J9F
    A rosin-derived compound used as a film-coating agent and binder in tablets and capsules. It helps create a protective layer around the medication and improves tablet hardness.
  • UNII 461N1O614Y
    A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • 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 K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII 0W8RRI5W5A
    A fatty acid derivative used as an emulsifier and surfactant in medications. It helps blend oily and water-based ingredients together to create a stable, uniform product.
  • 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 9LBV3F07AZ
    A synthetic, oil-soluble form of vitamin C used as an antioxidant to prevent degradation of the medicine and maintain its stability during storage.
  • 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.

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

The official label also statesPolyethylene, Dimethicone, Butyloctyl Salicylate, Petrolatum, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Methyl Dihydroabietate, Acrylates/ Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Octyldodecanol, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopherol (Vitamin E), Behenyl Olivate, Aluminum Hydroxide, Stearic Acid, Sorbitan Sesquioleate, Glyceryl Isostearate, Polyhydroxystearic Acid, Citric Acid, Benzylidene Dimethoxydimethylindanone, May contain: (CI 77491, CI 77494, CI 77499)

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 eachPer 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
Mineral KidStick SPF 40 Mineral Broad Spectrum SPF 40 Sunscreen UVA-UVB Suncreen 81 mg/g; 60 mg/g 49358-0576-01 MDSolarSciences 1 tube — — FDA listed —
Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen 81 mg/g; 60 mg/gthis 49358-0578-01 MDSolarSciences 1 tube — — FDA listed —
Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen 81 mg/g; 60 mg/g 49358-0577-01 MDSolarSciences 1 tube — — 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

🏛️
2023
On the market since
Jul 2023
📍
2026
Currently FDA-listed
3 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 Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen (this brand).

Top reported reactions

Acute Myeloid Leukaemia1
Exposure To Toxic Agent1
Product Contamination Chemical1

Age at onset

Adolescent1

Reporter sex

1 reports
Female · 100%

Serious outcomes

Hospitalization1
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
49358-0578-01 You're viewing this 1 TUBE in 1 CARTON (49358-578-01) / 17 g in 1 TUBE 2023-07-01 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 49358-578-01, 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: 49358-0578-01, written without dashes as 49358057801. 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 49358-0578-01, the first segment (49358) is the labeler code FDA assigned to MDSolarSciences; the middle segment (0578) 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 MDSolarSciences. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
MDSolarSciences 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 30 words ▾

Uses Helps prevent sunburn 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 88 words ▾

Directions Apply liberally 15 minutes before sun exposure Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Children under 6 months: Ask a doctor Sun Protection Measures: 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: Limit time in the sun, especially from 10a.m.- 2p.m. Wear long-sleeved shirts, pants, hats and sunglasses

⚠️ Warnings 54 words ▾

Warnings For external use only Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 38 words ▾

Other Information Rub in well. Protect the product in this container from excessive heat and direct sunlight May stain some fabrics You may report serious adverse reactions to: Report Reaction LLC PO Box 611, Pompton Plains, NJ 07444

🧪 Active Ingredient 11 words ▾

Active ingredients Purpose Titanium Dioxide 8.1% Sunscreen Zinc Oxide 6% Sunscreen

🧪 Inactive Ingredients 55 words ▾

Inactive Ingredients Polyethylene, Dimethicone, Butyloctyl Salicylate, Petrolatum, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Methyl Dihydroabietate, Acrylates/ Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Octyldodecanol, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopherol (Vitamin E), Behenyl Olivate, Aluminum Hydroxide, Stearic Acid, Sorbitan Sesquioleate, Glyceryl Isostearate, Polyhydroxystearic Acid, Citric Acid, Benzylidene Dimethoxydimethylindanone, May contain: (CI 77491, CI 77494, CI 77499)

🎯 Purpose 11 words ▾

Active ingredients Purpose Titanium Dioxide 8.1% Sunscreen Zinc Oxide 6% Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 49358-0577-01 · MDSolarSciences 49358-0579-01 · MDSolarSciences →
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.