Vacation SPF 50 Classic Avobenzone, Homosalate, Octisalate, Octocrylene 8.8 g/100mL; 2.9 g/100mL; 8.6 g/100mL; 4.9 g/100mL Spray, 177 mL — NDC 80641-0007-01 package photo

Vacation SPF 50 Classic Avobenzone, Homosalate, Octisalate, Octocrylene 8.8 g/100mL; 2.9 g/100mL; 8.6 g/100mL; 4.9 g/100mL Spray, 177 mL

by Vacation Inc. · 177 mL in 1 CAN (80641-007-01)
NDC 80641-0007-01
🏷️ FDA NDC (as labeled) 80641-007-01 billing pads the product segment with a zero
This package
Contains177 mL Pack sizes2 compare ↓
Also comes in: 50 ml 80641-0007-02
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 →

🆔 Identity & classification

FDA NDC (as labeled) 80641-007-01
Product NDC 80641-007
11-digit billing NDC 80641000701
UNII V06SV4M95S, G63QQF2NOX, 5A68WGF6WM, 4X49Y0596W
UPC 0380641003500
Application # M020
SPL Set ID f2780cb5-063c-10d3-e053-2995a90a8576
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-12-01
Route TOPICAL
Dosage form SPRAY
Substance HOMOSALATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE
Why two NDCs? The FDA registers this code as 80641-007-01 — 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 → 80641-0007-01. 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

LabelerVacation Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code80641
First marketedDec 2022
Product typeHuman Otc Drug
Portfolio34 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?

Vacation SPF 50 Classic is a topical spray sunscreen marketed as an over-the-counter monograph product. It contains four UV-filtering ingredients (avobenzone, homosalate, octisalate, and octocrylene) that are typically used together to absorb and scatter ultraviolet radiation from the sun. This combination of filters is commonly found in broad-spectrum sunscreen products intended for routine sun protection on exposed skin.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.
Try another pack size: 50 ml
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
Vacation SPF 50 Classic 8.8 g/100mL; 2.9 g/100mL; 8.6 g/100mL; 4.9 g/100mLthis 80641-0007-01 Vacation 177 ml 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

🏛️
2022
On the market since
Dec 2022
📍
2026
Currently FDA-listed
4 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 Vacation SPF 50 Classic (this brand).

Top reported reactions

Acute Myeloid Leukaemia2
Exposure To Toxic Agent2
Product Contamination Chemical2
Rash2
Anaphylactic Reaction1
Application Site Erythema1
Application Site Exfoliation1

Age at onset

Adolescent2
Adult1

Reporter sex

6 reports
Male · 20%
Female · 80%

Serious outcomes

Hospitalization2
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 2 1
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
80641-0007-01 You're viewing this 177 mL in 1 CAN (80641-007-01) 2022-12-01 Active
80641-0007-02 50 mL in 1 CAN (80641-007-02) 2025-02-24 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 80641-0007-01?
NDC 80641-0007-01 contains 177 mL — 177 ml in 1 can.
What is the difference between NDC 80641-0007-01 and NDC 80641-0007-02?
Both are Vacation SPF 50 Classic Avobenzone, Homosalate, Octisalate, Octocrylene 8.8 g/100mL; 2.9 g/100mL; 8.6 g/100mL; 4.9 g/100mL Spray — the drug itself is identical. NDC 80641-0007-01 is the 177 mL package, while NDC 80641-0007-02 is the 50 ml package.
What NDC number is used to bill for this package of Vacation SPF 50 Classic Avobenzone, Homosalate, Octisalate, Octocrylene 8.8 g/100mL; 2.9 g/100mL; 8.6 g/100mL; 4.9 g/100mL Spray?
Bill NDC 80641-0007-01 — the 11-digit billing format is 80641000701. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 80641-007-01, 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: 80641-0007-01, written without dashes as 80641000701. 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 80641-0007-01, the first segment (80641) is the labeler code FDA assigned to Vacation Inc.; the middle segment (0007) 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 Vacation Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 50 ml (80641-0007-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Vacation Inc. 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 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 94 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 Sun Protection Measure: 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. to 2 p.m. -Wear long-sleeved shirts, pants, hats, and sun glasses.

Children under 6 months: ask a doctor.

⚠️ Warnings 84 words

Warnings For external use only Flammable. Do not spray near heat, sparks, or sources of ignition (or flames). Contents under pressure. Do not puncture or incinerate can. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product -K eep out of eyes. Rinse with water to remove. -Do not store at temperatures above 120 F -Do not spray product directly on face. Spay onto hands and rub into face. Do not inhale spray.

🧪 Active Ingredient 10 words

Active Ingredients Avobenzone 2.9% Homosalate 8.8% Octisalate 4.9% Octocrylene 7.6%

🧪 Inactive Ingredients 41 words

Inactive Ingredients Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Aloe Barbadensis (Aloe Vera) Leaf Extract, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Cocos Nucifera (Coconut) Extract, Diisopropyl Adipate, Ethylhexyl Methoxycrylene, Fragrance, Musa Sapientum (Banana) Fruit Extract, Polyester-8, Tocopherol (Vitamin E)

🎯 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 ↗
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.