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Avobenzone, Homosalate, Octisalate 30 mg/g; 120 mg/g; 50 mg/g Spray, 156 g — NDC 11344-0943-34 package photo

Avobenzone, Homosalate, Octisalate 30 mg/g; 120 mg/g; 50 mg/g Spray, 156 g

by Nice-Pak Products, LLC · 156 g in 1 BOTTLE, SPRAY (11344-943-34)
NDC 11344-0943-34
🏷️ FDA NDC (as labeled) 11344-943-34 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) 11344-943-34
Product NDC 11344-943
11-digit billing NDC 11344094334
UNII G63QQF2NOX, V06SV4M95S, 4X49Y0596W
Application # M020
SPL Set ID af052521-bfa6-4142-a10b-ef51f474a077
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-11-08
Route TOPICAL
Dosage form SPRAY
Substance AVOBENZONE; HOMOSALATE; OCTISALATE
Why two NDCs? The FDA registers this code as 11344-943-34 — 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 → 11344-0943-34. 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

LabelerNice-Pak Products, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code11344
First marketedNov 2024
Product typeHuman Otc Drug
Portfolio45 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 spray sunscreen product containing three ultraviolet (UV) light filters: avobenzone, homosalate, and octisalate. These ingredients are commonly used together in sunscreen formulations to absorb and scatter UV radiation from the sun. The spray form allows application over larger body areas or hard-to-reach spots. This product is an over-the-counter monograph sunscreen, meaning it is marketed under FDA's established rules for this category of drug.

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 WC51CA3418
    A fragrance compound derived from cinnamon, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • 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 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 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 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 8SQ0VA4YUR
    A fragrance compound derived from natural sources, used to add pleasant scent to the medicine. It serves as a flavoring or aromatic agent to mask unpleasant tastes or improve the product's sensory appeal.
  • UNII D81QY6I88E
    Linalool is a natural fragrant oil found in plants like lavender and citrus. It's used in medicines as a flavoring agent and to mask unpleasant tastes or smells.
  • 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., diethylhexyl 2,6-naphthalate, diisopropyl adipate, acrylates/octylacrylamide copolymer, butyloctyl salicylate, neopentyl glycol diheptanoate, fragrance, amyl cinnamal, hydroxycitronellal, linalool, 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
Avobenzone, Homosalate, Octisalate 30 mg/g; 120 mg/g; 50 mg/g 75712-0943-14 Old 156 g — — FDA listed —
Sunscreen for Kids SPF 50 30 mg/g; 120 mg/g; 50 mg/g 63941-0962-14 Valu 156 g — — FDA listed —
Sunscreen for Kids SPF 50 30 mg/g; 120 mg/g; 50 mg/g 72476-0961-14 Retail 156 g — — FDA listed —
Avobenzone, Homosalate, Octisalate 30 mg/g; 120 mg/g; 50 mg/gthis 11344-0943-34 Nice-Pak 156 g — — FDA listed —
Avobenzone, Homosalate, Octisalate 30 mg/g; 120 mg/g; 50 mg/g 55910-0442-14 Old 156 g — — FDA listed —
Sport Sunscreen SPF 50 30 mg/g; 120 mg/g; 50 mg/g 72476-0943-14 Retail 156 g — — FDA listed —
Sunscreen for Kids SPF 50 30 mg/g; 120 mg/g; 50 mg/g 59450-0942-14 The 156 g — — FDA listed —
Sport Sunscreen SPF 50 30 mg/g; 120 mg/g; 50 mg/g 59450-0943-14 The 156 g — — FDA listed —
Avobenzone, Homosalate, Octisalate 30 mg/g; 120 mg/g; 50 mg/g 75712-0944-39 Old 312 g — — FDA listed —
Avobenzone, Homosalate, Octisalate 30 mg/g; 120 mg/g; 50 mg/g 79481-0949-01 Meijer, 156 g — — FDA listed —
Avobenzone, Homosalate, Octisalate 30 mg/g; 120 mg/g; 50 mg/g 75712-0949-14 Old 156 g — — FDA listed —
Sunscreen 30 mg/g; 120 mg/g; 50 mg/g 72476-0949-14 Retail 156 g — — FDA listed —
Avobenzone, Homosalate, Octisalate 30 mg/g; 120 mg/g; 50 mg/g 79481-0943-01 Meijer, 156 g — — FDA listed —
Sport Sunscreen SPF 50 30 mg/g; 120 mg/g; 50 mg/g 72036-0943-14 HARRIS 156 g — — FDA listed —
Avobenzone, Homosalate, Octisalate 30 mg/g; 120 mg/g; 50 mg/g 76162-0942-14 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

🏛️
2024
On the market since
Nov 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.

🔬 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 Avobenzone, Homosalate, Octisalate — the ingredient across all brands.

Top reported reactions

Skin Cancer65
Rash53
Pruritus37
Erythema29
Dyspnoea27
Malignant Melanoma27
Neoplasm Malignant27

Age at onset

Infant1
Child7
Adolescent5
Adult75
Elderly56

Reporter sex

760 reports
Male · 35%
Female · 65%

Serious outcomes

Hospitalization109
Disabling26
Death23
Life-threatening12
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 232 0
Most recent year is provisional (FAERS lags ~3 months).
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
11344-0943-34 You're viewing this 156 g in 1 BOTTLE, SPRAY (11344-943-34) 2024-11-08 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 11344-943-34, 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: 11344-0943-34, written without dashes as 11344094334. 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 11344-0943-34, the first segment (11344) is the labeler code FDA assigned to Nice-Pak Products, LLC; the middle segment (0943) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (34) 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 Nice-Pak Products, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Nice-Pak Products, 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 📦 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 145 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 5 words ▾

Warnings For external use only

🤒 Adverse Reactions 14 words ▾

Adverse Reaction Distributed by: Consumer Product Partners, LLC St. Louis, MO 63114 • 1-888-593-0593

📦 Storage and Handling 14 words ▾

Other information protect the product in this container from excessive heat and direct sun

🧪 Active Ingredient 8 words ▾

Active Ingredients Avobenzone 3% Homosalate 12% Octisalate 5%

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients alcohol denat., diethylhexyl 2,6-naphthalate, diisopropyl adipate, acrylates/octylacrylamide copolymer, butyloctyl salicylate, neopentyl glycol diheptanoate, fragrance, amyl cinnamal, hydroxycitronellal, linalool, 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 ↗
← 11344-0900-77 · Nice-Pak 11344-0947-34 · Nice-Pak →
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.