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HERBAL UV DEFENSE SPF40 Homosalate, Octisalate, Avobenzone, Octocrylene 9.5 mg/100mg; 5 mg/100mg; 3 mg/100mg; 2.6 mg/100mg Gel — NDC 68577-0199-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

HERBAL UV DEFENSE SPF40 Homosalate, Octisalate, Avobenzone, Octocrylene 9.5 mg/100mg; 5 mg/100mg; 3 mg/100mg; 2.6 mg/100mg Gel — NDC 68577-199-00 (Billing 68577-0199-00)

by COSMAX USA, CORPORATION · 1 TUBE in 1 CARTON / 30 mg in 1 TUBE

This is a package of HERBAL UV DEFENSE SPF40 Homosalate, Octisalate, Avobenzone, Octocrylene 9.5 mg/100mg; 5 mg/100mg; 3 mg/100mg; 2.6 mg/100mg Gel from COSMAX USA, CORPORATION, marketed since Jan 2024 and currently FDA-listed. It is this product's only package size.

NDC 68577-0199-00
🏷️ FDA NDC (as labeled) 68577-199-00 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 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

NDC database record

One package, one record: these facts belong to NDC 68577-199-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68577 labeler · 199 product · 00 package
Package marketed since
Jan 3, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6857719900 9
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68577-199-00
Product NDC 68577-199
11-digit billing NDC 68577019900
UNII V06SV4M95S, 4X49Y0596W, G63QQF2NOX, 5A68WGF6WM
Application # M020
SPL Set ID 2a76fd94-2f1f-e6d8-e063-6294a90a287c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-01-03
Route TOPICAL
Dosage form GEL
Substance HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 68577-199-00 — 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 → 68577-0199-00. 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.

Clinical

🧪 What is this product?

This is a topical gel sunscreen marketed as an over-the-counter monograph product. It contains four ultraviolet (UV) filters: homosalate, octisalate, avobenzone, and octocrylene. These ingredients are commonly used together in sunscreen formulations to absorb and scatter UV radiation from the sun. The product is applied to the skin to help protect 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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68577-0199-00 You're viewing this Main listing 1 TUBE in 1 CARTON / 30 mg in 1 TUBE 2024-01-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Herbal Uv Defense Spf40 9.5 mg/100mg; 5 mg/100mg; 3 mg/100mg; 2.6 mg/100mgthis 68577-0199-00 COSMAX 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

🏛️
2024
On the market since
Jan 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.

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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 LU49E6626Q
    A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
  • UNII W59H9296ZG
    A synthetic polymer made from acrylic compounds and vinylpyrrolidone. It works as a film-former and thickener in topical products, helping create a smooth texture and improve how the medication spreads on skin.
  • UNII 32766B2FHX
    A plant extract from the root of Angelica gigas, used primarily as a flavoring agent and traditional ingredient to add taste and aroma to oral medicines.
  • UNII Z129UMU8LE
    A fragrant oil extracted from basil leaves, used as a flavoring agent to improve taste and provide the characteristic aroma in medicines.
  • UNII 3SCV180C9W
    Betaine is a naturally occurring organic compound found in plants and animals. In medicines, it acts as an osmoprotectant and stabilizer, helping maintain the product's moisture balance and preserve its chemical stability during storage.
  • UNII 9XRL057X90
    A plant-derived gum that acts as a thickener and binder in medicines. It helps create the right texture and holds ingredients together in tablets, capsules, or liquids.
  • UNII UOI4FT57BZ
    Broccoli is a vegetable extract used in medicines as a source of natural compounds and nutrients. It may serve as a filler, colorant, or nutritional additive in formulations.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • 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 EXY4496LWD
    A plant-derived ingredient from the pods of the Caesalpinia spinosa tree, native to South America. It's used as a natural thickener, binder, and source of fiber in formulations.
  • 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 K6MOM3T5YL
    A synthetic polymer made from acrylic acid, crosslinked for stability. Used as a thickener and gelling agent to give medicines like creams and gels their texture, and as a binder to hold tablet ingredients together.
  • UNII BD70459I50
    Citrus bioflavonoids are plant compounds extracted from citrus fruits. In medicines, they act as antioxidants and may help improve ingredient stability and absorption.
  • UNII 8DW238I7ZI
    A natural seed extract from a grain plant, used as a filler and texture agent in formulations. It adds bulk to the medicine and may help with moisture absorption and stability.
  • UNII 0IAF2L30VS
    A synthetic chemical compound used as a plasticizer and conditioning agent in topical formulations. It helps soften and improve the flexibility of film coatings and suspensions applied to skin.
  • UNII 3V7K3IA58X
    A synthetic compound derived from glutamic acid, used as an emulsifier and skin-conditioning agent in topical formulations to help blend oil and water components and improve product texture and spreadability.
  • UNII E107L85C40
    Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 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 2788Z9758H
    A plant extract from licorice root used as a sweetener, flavoring agent, and natural emulsifier in medicines. It helps improve taste and may aid in keeping ingredients evenly mixed throughout the product.
  • UNII J2S07SB0YL
    A protein derived from wheat that has been broken down into smaller pieces using enzymes. It's used in formulations as a film-former and texturizer to help bind ingredients together and improve product consistency.
  • UNII G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII T479H08K2O
    A red seaweed extract 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 ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII I9GRO824LL
    Lemon oil is a natural fragrant extract from lemon peel. It's used in medicines as a flavoring agent to mask unpleasant tastes and improve how the medicine tastes to patients.
  • UNII S73ZQI0GXM
    Methyl trimethicone is a silicone-based lubricant and glidant used in tablets and capsules. It reduces friction between particles and equipment during manufacturing, helping the medicine flow smoothly and compress evenly.
  • UNII AKN3KSD11B
    Orange oil obtained by cold pressing orange peel. It serves as a flavoring agent and fragrance in medicines to improve taste and aroma.
  • UNII 3K0J1S7QGC
    A fragrant essential oil derived from geranium flowers, used as a flavoring and fragrance agent to improve the taste and aroma of medicines.
  • 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 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • 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 RGT30824HY
    A plant extract from the nasturtium flower used as a natural coloring agent and flavoring ingredient in medicines and supplements.
  • 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.

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

The official label also statesInactive Ingredients Water, Isoamyl Laurate, Glycerin, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polyglyceryl-10 Stearate, Poly C10-30 Alkyl Acrylate, Polyhydroxystearic Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetearyl Olivate, Sorbitan Olivate, Hydroxyacetoph-enone, Phenoxyethanol, Polyglyceryl-10 Laurate, Microcrystalline Cellulose, Limonene, Rubus Idaeus (Raspberry) Seed Oil, Xanthan Gum, Glycine Soja (Soybean) Oil, Cellulose Gum, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Polyglyceryl-3 Diisostearate, Citrus Limon (Lemon) Peel Oil, Linalool, Citrus Aurantium Dulcis (Orange) Peel Oil, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Lavandula Angustifolia (Lavender) Oil, Propanediol, Ocimum Basilicum (Basil) Oil, Pelargonium Graveolens Flower Oil, Citral, Centella Asiatica Extract

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

LabelerCOSMAX USA, CORPORATION
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code68577
First marketedJan 2024
Product typeHuman Otc Drug
Portfolio91 products on file

More NDCs from COSMAX USA, CORPORATION labeler code 68577

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 5 words ▾

USES Uses Helps prevent sunburn

⏱️ Dosage and Administration 95 words ▾

DIRECTIONS Directions Apply liberally 15 minutes before sun exposure 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: Ask a doctor

⚠️ Warnings 58 words ▾

WARNINGS Warnings 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 . If product is swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 10 words ▾

Active Ingredients Homosalate 9.5% Octisalate 5% Avobenzone 3.0% Octocrylene 2.6%

🧪 Inactive Ingredients 93 words ▾

Inactive Ingredients Water, Isoamyl Laurate, Glycerin, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polyglyceryl-10 Stearate, Poly C10-30 Alkyl Acrylate, Polyhydroxystearic Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetearyl Olivate, Sorbitan Olivate, Hydroxyacetoph-enone, Phenoxyethanol, Polyglyceryl-10 Laurate, Microcrystalline Cellulose, Limonene, Rubus Idaeus (Raspberry) Seed Oil, Xanthan Gum, Glycine Soja (Soybean) Oil, Cellulose Gum, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Polyglyceryl-3 Diisostearate, Citrus Limon (Lemon) Peel Oil, Linalool, Citrus Aurantium Dulcis (Orange) Peel Oil, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Lavandula Angustifolia (Lavender) Oil, Propanediol, Ocimum Basilicum (Basil) Oil, Pelargonium Graveolens Flower Oil, Citral, Centella Asiatica Extract

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin.

📄 When Using This Product 13 words ▾

When using this product keep out of eyes. Rinse with water to remove

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask a doctor if rash occurs.

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center right away.

📄 Other Information 13 words ▾

OTHER INFORMATION Other information Protect this product from excessive heat and direct sun

📄 Package Label / Principal Display Panel 5 words ▾

Packaging Label tube Outer package

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

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 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 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.
← 68577-0198-00 · COSMAX 68577-0200-01 · 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.