Home › NDC Lookup › Ingredients › Avebonzone, Homosalate, Octisalate › 76162-0979-14
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Avebonzone, Homosalate, Octisalate 30 mg/g; 150 mg/g; 50 mg/g Spray, 156 g

by Topco Associates LLC · 156 g in 1 CAN (76162-979-14)
NDC 76162-0979-14
🏷️ FDA NDC (as labeled) 76162-979-14 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 13, 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) 76162-979-14
Product NDC 76162-979
11-digit billing NDC 76162097914
UNII G63QQF2NOX, V06SV4M95S, 4X49Y0596W
Application # M020
SPL Set ID 5865f0e5-14b2-c4bf-e063-6294a90a4710
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-06
Route TOPICAL
Dosage form SPRAY
Substance AVOBENZONE; HOMOSALATE; OCTISALATE
Why two NDCs? The FDA registers this code as 76162-979-14 — 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 → 76162-0979-14. 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

LabelerTopco Associates LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code76162
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio408 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 sunscreen spray containing three UV-filtering agents commonly used to help block ultraviolet radiation from the sun. Avobenzone, homosalate, and octisalate are active ingredients typically found in sunscreen products and work together as part of an over-the-counter monograph formulation. The spray form allows for convenient application to the skin. This product is marketed under FDA's established rules for sunscreen ingredients rather than as an individually reviewed drug 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 P01OUT964K
    A fragrant plant-derived alcohol used as a flavoring agent and fragrance component in medicines. It provides taste and aroma to make the product more pleasant to use.
  • UNII 7LL6SY9YFV
    A synthetic polymer made from acrylic compounds. It forms a protective film coating on tablets or capsules to control how fast the medicine dissolves and releases in the digestive tract.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII N863NB338G
    Benzyl benzoate is a liquid organic compound used as a solvent and preservative in medicines. It helps dissolve active ingredients and can extend shelf life by preventing microbial growth in liquid formulations.
  • 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 T7540GJV69
    A synthetic fragrance compound used as a flavor or scent ingredient in medicines. It helps mask unpleasant tastes or odors in the formulation to make the medication more palatable.
  • UNII I0DQJ7YGXM
    A synthetic chemical compound used as a plasticizer in pharmaceutical coatings. It makes film coatings more flexible and durable so they don't crack or peel during manufacturing and storage.
  • UNII P7E6YFV72X
    Diisopropyl adipate is a clear, oily liquid derived from adipic acid. It acts as a plasticizer and solvent in medicines, helping soften coatings and improve how the drug dissolves or spreads in the body.
  • UNII 5LKW3C543X
    A synthetic oily liquid derived from neopentyl glycol and heptanoic acid. It serves as an emollient and solvent in formulations, helping to dissolve or suspend active ingredients and improve the texture and spreadability of topical products.

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

The official label also statesalcohol denat., diisopropyl adipate, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, neopentyl glycol diheptanoate, acrylates/octylacrylamide copolymer, fragrance, benzyl benzoate, butylphenyl methylpropional, citronellol, tocopheryl acetate

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Avebonzone, Homosalate, Octisalate 30 mg/g; 150 mg/g; 50 mg/g 76162-0946-14 Topco 156 g — — FDA listed —
Avebonzone, Homosalate, Octisalate 30 mg/g; 150 mg/g; 50 mg/gthis 76162-0979-14 Topco 156 g — — 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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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
76162-0979-14 You're viewing this 156 g in 1 CAN (76162-979-14) 2026-08-06 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 — 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 FDA registers it as 76162-979-14, 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: 76162-0979-14, written without dashes as 76162097914. 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 76162-0979-14, the first segment (76162) is the labeler code FDA assigned to Topco Associates LLC; the middle segment (0979) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (14) 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 Topco Associates LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Topco Associates 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 🤒 Adverse Reactions 🧪 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 144 words ▾

Directions spray liberally and spread evenly by hand 15 minutes before sun exposure apply to all skin exposed to the sun hold container 4 to 6 inches from the skin to apply do not spray directly into face. Spray on hands then apply to face. do not apply in windy conditions use in a well-ventilated area and avoid inhalation reapply: after 80 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 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 29 words ▾

Warnings For external use only Flammable: Keep away from fire or flame. after application, wait until product dries before approaching a source of heat or flame, or before smoking

🤒 Adverse Reactions 25 words ▾

Adverse Reaction DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143 © TOPCO VIJA0326 QUESTIONS? 1-888-423-0139 [email protected] www.topecarebrand.com Visit here for more information: http://topbrnds.com/qufi2c QUALITY GUARANTEED

🧪 Active Ingredient 8 words ▾

Active ingredients Avobenzone 3% Homosalate 15% Octisalate 5%

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients alcohol denat., diisopropyl adipate, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, neopentyl glycol diheptanoate, acrylates/octylacrylamide copolymer, fragrance, benzyl benzoate, butylphenyl methylpropional, citronellol, tocopheryl acetate

🎯 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 ↗
← 76162-0970-32 · Topco 76162-0980-05 · Topco →
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.