Vacation SPF 50 Classic Avobenzone, Homosalate, Octisalate, Octocrylene 2.8 g/100mL; 9.8 g/100mL; 4.9 g/100mL; 9.5 g/100mL Lotion, 591 mL — NDC 80641-0006-18 package photo

Vacation SPF 50 Classic Avobenzone, Homosalate, Octisalate, Octocrylene 2.8 g/100mL; 9.8 g/100mL; 4.9 g/100mL; 9.5 g/100mL Lotion, 591 mL

by Vacation INC. · 591 mL in 1 BOTTLE, PUMP (80641-006-18)
NDC 80641-0006-18
🏷️ FDA NDC (as labeled) 80641-006-18 billing pads the product segment with a zero
This package
Contains591 mL Pack sizes5 compare ↓
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 →

🆔 Identity & classification

FDA NDC (as labeled) 80641-006-18
Product NDC 80641-006
11-digit billing NDC 80641000618
UNII G63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM
UPC 0380641002688
Application # M020
SPL Set ID f268fb1c-d7c2-f2f9-e053-2995a90a9e22
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-11-01
Route TOPICAL
Dosage form LOTION
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 80641-006-18 — 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 → 80641-0006-18. 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 marketedNov 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 lotion sunscreen marketed as an over-the-counter product under FDA's monograph rules. It contains four UV-filtering chemicals (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 application to 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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 4AJZ4765R9
    A flavoring agent derived from bananas that gives medicine a banana taste. It's added to make oral medications more palatable, especially for children.
  • 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 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 1E5KJY107T
    A liquid mixture derived from coconut oil, coconut alkanes serve as a solvent and lubricant in medicines. They help dissolve active ingredients and reduce friction during manufacturing and tablet compression.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII 8D9H4QU99H
    A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • 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 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII 5EM498GW35
    A mixture of aromatic compounds used to add pleasant smell to the medicine. Fragrance helps mask unpleasant tastes or odors, making the medication easier to take.
  • UNII 258491E1RZ
    A waxy substance made from glycerin and stearic acid, commonly used as an emulsifier to help blend oil and water ingredients together in medicines. It also helps thicken and stabilize the product's texture.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII GSS77345H7
    A modified cornstarch derivative that acts as a thickener and binder in medications. It helps hold tablet ingredients together and can improve how quickly the medicine dissolves in the stomach.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • 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 88496G1ERL
    Sodium phytate is a plant-derived salt used in medications as a chelating agent and preservative. It helps stabilize formulations and may improve how the body absorbs certain minerals in the medicine.
  • 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 K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • 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 7C98FKB43H
    Sodium acrylate is a synthetic polymer (plastic-like material) used as a superabsorbent and thickening agent in medicines. It helps control the consistency and release of active ingredients, particularly in gel or semi-solid formulations.
  • UNII 65A9F4P024
    A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
  • UNII 24SC3U704I
    A powdery carbohydrate extracted from tapioca plant roots. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your digestive system.
  • 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 587WKM3S9Q
    A synthetic polymer made from trimethylpentanediol, adipic acid, and glycerin. It acts as a thickener and stabilizer in formulations, helping maintain consistent texture and prevent ingredient separation.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesAloe Barbadensis (Aloe Vera) Leaf Juice, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexyl Palmitate, Ethylhexylglycerin, Fragrance, Glycerin, Musa Paradisiaca (Banana) Fruit Extract, Niacinamide, Phenoxyethanol, Silica, Sodium Hyaluronate, Sodium Phytate, Sodium Polyacrylate, Sodium Stearoyl Glutamate, Tocopherol (Vitamin E), Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Water

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 DailyMedingredient 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.
Try another pack size: 177 mL 30 ml 100 ml 177 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 2.8 g/100mL; 9.8 g/100mL; 4.9 g/100mL; 9.5 g/100mLthis 80641-0006-18 Vacation 591 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
Nov 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
80641-0006-01 100 mL in 1 TUBE (80641-006-01) 2022-11-01 Active
80641-0006-04 177 mL in 1 TUBE (80641-006-04) 2026-03-09 Active
80641-0006-08 1 TUBE in 1 BLISTER PACK (80641-006-08) / 177 mL in 1 TUBE (80641-006-04) 2026-03-09 Active
80641-0006-18 You're viewing this 591 mL in 1 BOTTLE, PUMP (80641-006-18) 2024-03-01 Active
80641-0006-80 30 mL in 1 TUBE (80641-006-80) 2022-11-01 Active

Pack size FAQ

What quantity is in NDC 80641-0006-18?
NDC 80641-0006-18 contains 591 mL — 591 ml in 1 bottle, pump.
What is the difference between NDC 80641-0006-18 and NDC 80641-0006-80?
Both are Vacation SPF 50 Classic Avobenzone, Homosalate, Octisalate, Octocrylene 2.8 g/100mL; 9.8 g/100mL; 4.9 g/100mL; 9.5 g/100mL Lotion — the drug itself is identical. NDC 80641-0006-18 is the 591 mL package, while NDC 80641-0006-80 is the 30 ml package.
What NDC number is used to bill for this package of Vacation SPF 50 Classic Avobenzone, Homosalate, Octisalate, Octocrylene 2.8 g/100mL; 9.8 g/100mL; 4.9 g/100mL; 9.5 g/100mL Lotion?
Bill NDC 80641-0006-18 — the 11-digit billing format is 80641000618. 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) ✓ 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 80641-006-18, 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: 80641-0006-18, written without dashes as 80641000618. 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 80641-0006-18, the first segment (80641) is the labeler code FDA assigned to Vacation INC.; the middle segment (0006) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (18) 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 4 other package presentations of this same product, including 1 tube (80641-0006-08), 30 ml (80641-0006-80), 100 ml (80641-0006-01). 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 Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.

To decrease the risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses Children under 6 months of age: ask a physician.

⚠️ Warnings 35 words

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

🧪 Active Ingredient 8 words

Avobenzone (2.%), Homosalate (9.8%), Octisalate (4.9%), Octocrylene (9.5%)

🧪 Inactive Ingredients 48 words

Aloe Barbadensis (Aloe Vera) Leaf Juice, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexyl Palmitate, Ethylhexylglycerin, Fragrance, Glycerin, Musa Paradisiaca (Banana) Fruit Extract, Niacinamide, Phenoxyethanol, Silica, Sodium Hyaluronate, Sodium Phytate, Sodium Polyacrylate, Sodium Stearoyl Glutamate, Tocopherol (Vitamin E), Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Water

🎯 Purpose 1 words

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.