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Invisible Sunscreen SPF 40 Homosalate, Octisalate, Avobenzone, Octocrylene 10 mg/100mg; 5 mg/100mg; 2.6 mg/100mg; 3 mg/100mg Cream — NDC 68577-0196-01 package photo

Invisible Sunscreen SPF 40 Homosalate, Octisalate, Avobenzone, Octocrylene 10 mg/100mg; 5 mg/100mg; 2.6 mg/100mg; 3 mg/100mg Cream

by COSMAX USA, CORPORATION · 1 BOTTLE, PLASTIC in 1 CARTON (68577-196-01) / 50 mg in 1 BOTTLE, PLASTIC
NDC 68577-0196-01
🏷️ FDA NDC (as labeled) 68577-196-01 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) 68577-196-01
Product NDC 68577-196
11-digit billing NDC 68577019601
UNII V06SV4M95S, 4X49Y0596W, 5A68WGF6WM, G63QQF2NOX
Application # M020
SPL Set ID 29fe531e-2ade-170f-e063-6394a90a1396
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-06-28
Route TOPICAL
Dosage form CREAM
Substance HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE
Why two NDCs? The FDA registers this code as 68577-196-01 — 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 → 68577-0196-01. 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

LabelerCOSMAX USA, CORPORATION
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code68577
First marketedJun 2024
Product typeHuman Otc Drug
Portfolio91 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?

Invisible Sunscreen SPF 40 is a topical cream containing four UV-filtering agents: homosalate, octisalate, avobenzone, and octocrylene. These ingredients are commonly used in sunscreen products to absorb and scatter ultraviolet radiation from the sun. This is an over-the-counter monograph drug, meaning it is marketed under FDA's established category rules for sunscreen products rather than as an individually reviewed application. The cream is applied to the skin as a protective barrier against sun exposure.

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 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 Q95M2P1KJL
    A silicone-based ingredient that acts as a lubricant and glidant. It helps the tablet or capsule move smoothly through manufacturing equipment and improves powder flow during production.
  • UNII O4I3UFO6ZF
    A silicone-based polymer blend that acts as an emulsifier and texture modifier. It helps keep oil and water mixed together in the formulation and gives the product a smooth, spreadable consistency.
  • 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 SA6A6V432S
    Dimethyl isosorbide is a clear liquid solvent derived from natural sugar sources. It helps dissolve active ingredients and improve their absorption in liquid medicines and topical products.
  • UNII 2865993309
    Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
  • UNII A8289P68Y2
    Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
  • UNII S870P55O2W
    Isomalt is a sugar alcohol made from sugar that's used as a sweetener and bulking agent in medicines. It helps give tablets and powders the right texture and sweetness while having minimal calories.
  • UNII 834K0WOS5G
    A natural fat extracted from sunflower seeds. It acts as an emulsifier and lubricant in medicines, helping mix ingredients that don't normally blend together and allowing the product to flow smoothly during manufacturing.
  • 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 965K72OQXO
    A silicone-based ingredient made from polymers that are chemically linked together. It works as an emulsifier and texture modifier to help blend oil and water components and create a smooth, stable consistency in cosmetic or topical formulations.
  • UNII 59Z907ZB69
    A synthetic silicone polymer used as a glidant and anti-caking agent. It reduces friction between particles, helping powders and tablets flow smoothly during manufacturing and use.
  • UNII 7Y1255HVXR
    A plant-derived oil from sesame seeds used as an emollient and solvent in topical formulations. It helps distribute active ingredients evenly and keeps products from drying out.
  • 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 OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • 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.
  • UNII 653OHN32Q1
    A natural extract from grape skin that acts as a colorant and antioxidant in the formulation. It helps protect the medicine from degradation and may add color without synthetic dyes.
  • 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.

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

The official label also statesInactive Ingredients: Isodecane, Ethylhexyl Pamitate, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Caprylyl Methicone, Polymethylsislsesquioxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Sesamum Indicum(Sesame) Seed Extract, Tocopherol, Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Lecithin, Fragrance, Silica, Water, PEG-12 Dimethicone/PPG-20 Crosspolymer, Dimethyl Isosorbide, Sodium Benzoate

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
Invisible Sunscreen SPF 40 10 mg/100mg; 5 mg/100mg; 2.6 mg/100mg; 3 mg/100mgthis 68577-0196-01 COSMAX 1 bottle — — FDA listed —
Invisible Sunscreen SPF 40 10 mg/100mg; 5 mg/100mg; 2.6 mg/100mg; 3 mg/100mg 84426-0001-01 PARTICLE 1 bottle — — 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

🏛️
2024
On the market since
Jun 2024
📍
2026
Currently FDA-listed
2 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68577-0196-01 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (68577-196-01) / 50 mg in 1 BOTTLE, PLASTIC 2024-06-28 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 68577-196-01, 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: 68577-0196-01, written without dashes as 68577019601. 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 68577-0196-01, the first segment (68577) is the labeler code FDA assigned to COSMAX USA, CORPORATION; the middle segment (0196) 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 COSMAX USA, CORPORATION. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
COSMAX USA, CORPORATION 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 30 words ▾

Uses Helps prevent sunburn If used as directed with other Sun Protection Measures (see Directions ) decrease the risk of skin cancer and early skin aging damaged by the sun

⏱️ Dosage and Administration 99 words ▾

Directions Directions Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating Reapply 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 value of 15 or higher and other sun protection measures including Limit time in the sun, especially from 10 a.m. - 2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months of age: Ask a doctor

⚠️ Warnings 55 words ▾

Warnings For external use only Do not use on damaged or broken skin When you use 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. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 10 words ▾

Active ingredients Homosalate 10% Octisalate 5% Avobenzone 3% Octocrylene 2.6%

🧪 Inactive Ingredients 43 words ▾

Inactive Ingredients: Isodecane, Ethylhexyl Pamitate, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Caprylyl Methicone, Polymethylsislsesquioxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Sesamum Indicum(Sesame) Seed Extract, Tocopherol, Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Lecithin, Fragrance, Silica, Water, PEG-12 Dimethicone/PPG-20 Crosspolymer, Dimethyl Isosorbide, Sodium Benzoate

🎯 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 ↗
← 68577-0195-00 · COSMAX 68577-0197-00 · COSMAX →
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.