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Vacation Instant Browning Avobenzone Octisalate Octocrylene 2.9 g/100mL; 9.5 g/100mL; 4.9 g/100mL Lotion, 30 mL — NDC 80641-0521-80 package photo

Vacation Instant Browning Avobenzone Octisalate Octocrylene 2.9 g/100mL; 9.5 g/100mL; 4.9 g/100mL Lotion, 30 mL

by Vacation Inc. · 30 mL in 1 BOTTLE (80641-521-80)
NDC 80641-0521-80
🏷️ FDA NDC (as labeled) 80641-521-80 billing pads the product segment with a zero
This package
Contains30 mL Pack sizes2 compare ↓
Also comes in: 148 ml 80641-0521-10
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 →

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) 80641-521-80
Product NDC 80641-521
11-digit billing NDC 80641052180
UNII G63QQF2NOX, 5A68WGF6WM, 4X49Y0596W
Application # M020
SPL Set ID 13028f61-3f62-22cc-e063-6394a90a6bf1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-03-06
Route TOPICAL
Dosage form LOTION
Substance AVOBENZONE; OCTOCRYLENE; OCTISALATE
Why two NDCs? The FDA registers this code as 80641-521-80 — 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 → 80641-0521-80. 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 marketedMar 2024
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 Instant Browning is a lotion applied to the skin that contains three ultraviolet (UV) filter ingredients: avobenzone, octisalate, and octocrylene. These ingredients are commonly used together in sunscreen products to help absorb and scatter UV radiation from the sun. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established safety and effectiveness guidelines for sunscreen products in this category.

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 54JB35T06A
    A natural oil extracted from apricot pits, used as an emollient and lubricant in topical products. It helps soften the skin and improves the texture and spreadability of creams and lotions.
  • UNII IK55HKE887
    A natural oil extracted from arabica coffee beans. It adds flavor and aroma to the medicine and may help improve taste or serve as a lubricant in the formulation.
  • UNII 1QR1QRA9BU
    A fatty alcohol derived from peanut oil or made synthetically. It serves as an emollient and thickener in creams and ointments, helping create smooth texture and improve product consistency.
  • UNII 9G1OE216XY
    Docosanol is a waxy, fatty alcohol derived from plant sources. It acts as an emollient and thickener in topical medicines, helping to soften the skin and improve product texture and stability.
  • UNII S347WMO6M4
    Beta-sitosterol is a plant-derived sterol (waxy substance from vegetable oils and seeds). In medicines, it acts as an emulsifier or thickening agent to help blend oil and water-based ingredients and improve texture.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • 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 0C9AC7D6XU
    A plant-derived fat from shea nut kernels that remains after soap-making. It acts as a moisturizer, emollient, and texture enhancer in topical formulations, helping soften skin and improve product spreadability.
  • UNII 114P5I43UJ
    A hydrocarbon oil derived from petroleum, containing 13 to 15 carbon atoms per molecule. It serves as a lubricant and glidant in tablets and capsules to reduce friction during manufacturing and improve powder flow.
  • UNII UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII 595AO13F11
    Carrot seed oil is a plant-based oil extracted from carrot seeds. It's used in medicines as a flavor and fragrance component, and may help distribute active ingredients evenly throughout the formulation.
  • 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 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII ICS790225B
    A plant-derived cleaning agent made from coconut oil and glucose. It works as a surfactant and emulsifier to help mix oil and water-based ingredients together in the formulation.
  • UNII 512OYT1CRR
    Cocoa butter is a natural fat extracted from cocoa beans. It's used in medicines as a base for suppositories and as a lubricant to help pills dissolve smoothly.
  • UNII Z17H97EA6Y
    A plant-derived mild cleanser made from natural sugars and oils. It acts as an emulsifier and surfactant to help mix water and oil-based ingredients together in the medicine.
  • 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 5B8915UELW
    A plant-derived compound used as an antioxidant in medicines. It helps prevent spoilage and degradation of active ingredients during storage by protecting them from oxidative damage.
  • UNII 8RQ2839AVG
    A plant oil derived from hazelnuts, used as a solvent or carrier to dissolve or suspend active ingredients. It also helps improve the taste and texture of liquid medicines.
  • 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 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • UNII 76LN7P7UCU
    Lauryl glucoside is a mild plant-based cleansing agent made from coconut oil and glucose. It's used in medicines as a surfactant to help dissolve and distribute ingredients evenly throughout the formulation.
  • UNII MCA43PK7MH
    Octyldodecyl oleate is a synthetic oil derived from oleic acid. It's used in medicines as an emollient and lubricant to improve texture, help ingredients mix smoothly, and enhance skin feel in topical formulations.
  • UNII F3VOA31UHQ
    A natural oil extracted from passion fruit seeds. It serves as an emollient and skin-conditioning agent in topical products, helping to soften and moisturize the formulation while improving texture and spreadability.
  • UNII R6Q3791S76
    Sodium gluconate is a salt derived from gluconic acid, a naturally occurring compound. In medicines, it functions as a buffering agent to help maintain stable pH and as a chelating agent that can bind minerals in 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 7QWM220FJH
    Squalene is a natural oil-like substance found in shark liver and some plants. It's used in medicines as an emulsifier to help mix oil and water-based ingredients together.
  • 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 2P6O7CFW5K
    Triheptanoin is a synthetic fat made from glycerol and seven-carbon fatty acids. It's used as a caloric supplement and carrier in certain formulations to deliver active ingredients and provide nutritional support.
  • 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 0A3F415158
    A flavoring extract from vanilla bean fruit that gives medicine a pleasant vanilla taste and aroma. It masks bitter or unpleasant flavors to make the medicine easier to take.
  • 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.

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

The official label also statesOCTISALATE, OCTOCRYLENE, ACETYL L-TYROSINE, LEVOMENOL, MAGNESIUM STEARATE, OCTYLDODECYL OLEATE, WATER, C13-15 ALKANE, PROPANEDIOL, COCOA BUTTER, TOCOPHEROL, VANILLA PLANIFOLIA OIL, DOCOSANOL, DECYL GLUCOSIDE, SODIUM METABISULFITE, PORPHYRIDIUM PURPUREUM, ALCOHOL, BUTYLOCTYL SALICYLATE, BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCOL, CETOSTEARYL ALCOHOL, CETYL ALCOHOL, CITRIC ACID MONOHYDRATE, COCO GLUCOSIDE, ARABICA COFFEE OIL, EUROPEAN HAZELNUT OIL, DIHYDROXYACETONE, DIMETHICONE, ETHYLENE BRASSYLATE, ETHYL FERULATE, GLYCERIN, FERRIC OXIDE RED, LAURYL GLUCOSIDE, PASSIFLORA EDULIS SEED OIL, CHASTE TREE

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 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: 148 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 Instant Browning 2.9 g/100mL; 9.5 g/100mL; 4.9 g/100mLthis 80641-0521-80 Vacation 30 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

🏛️
2024
On the market since
Mar 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 Octisalate Octocrylene — the ingredient across all brands.

Top reported reactions

Rash3
Skin Cancer3
Application Site Burn2
Hypersensitivity2
Product Expiration Date Issue2
Product Lot Number Issue2
Acne1

Age at onset

Adult1
Elderly2

Reporter sex

20 reports
Male · 12%
Female · 88%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2 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
80641-0521-10 148 mL in 1 BOTTLE (80641-521-10) 2024-03-06 Active
80641-0521-80 You're viewing this 30 mL in 1 BOTTLE (80641-521-80) 2024-03-06 Active

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

Pack size FAQ

What quantity is in NDC 80641-0521-80?
NDC 80641-0521-80 contains 30 mL — 30 ml in 1 bottle.
What is the difference between NDC 80641-0521-80 and NDC 80641-0521-10?
Both are Vacation Instant Browning Avobenzone Octisalate Octocrylene 2.9 g/100mL; 9.5 g/100mL; 4.9 g/100mL Lotion — the drug itself is identical. NDC 80641-0521-80 is the 30 mL package, while NDC 80641-0521-10 is the 148 ml package.
What NDC number is used to bill for this package of Vacation Instant Browning Avobenzone Octisalate Octocrylene 2.9 g/100mL; 9.5 g/100mL; 4.9 g/100mL Lotion?
Bill NDC 80641-0521-80 — the 11-digit billing format is 80641052180. 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 80641-521-80, 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: 80641-0521-80, written without dashes as 80641052180. 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 80641-0521-80, the first segment (80641) is the labeler code FDA assigned to Vacation Inc.; the middle segment (0521) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (80) 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 148 ml (80641-0521-10). 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 31 words ▾

Indications and Usage Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin agin caused by the sun.

⏱️ Dosage and Administration 23 words ▾

Dosage and administration Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use water-resistent sunscreen if swimming or sweating

⚠️ Warnings 52 words ▾

Warnings For external use only Do not use on damaged or broken skin When using this product, keep out of reach of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs In case of ingestion, get medical help or contact a Poison Control Center right away

🧪 Inactive Ingredients 72 words ▾

Inactives OCTISALATE, OCTOCRYLENE, ACETYL L-TYROSINE, LEVOMENOL, MAGNESIUM STEARATE, OCTYLDODECYL OLEATE, WATER, C13-15 ALKANE, PROPANEDIOL, COCOA BUTTER, TOCOPHEROL, VANILLA PLANIFOLIA OIL, DOCOSANOL, DECYL GLUCOSIDE, SODIUM METABISULFITE, PORPHYRIDIUM PURPUREUM, ALCOHOL, BUTYLOCTYL SALICYLATE, BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCOL, CETOSTEARYL ALCOHOL, CETYL ALCOHOL, CITRIC ACID MONOHYDRATE, COCO GLUCOSIDE, ARABICA COFFEE OIL, EUROPEAN HAZELNUT OIL, DIHYDROXYACETONE, DIMETHICONE, ETHYLENE BRASSYLATE, ETHYL FERULATE, GLYCERIN, FERRIC OXIDE RED, LAURYL GLUCOSIDE, PASSIFLORA EDULIS SEED OIL, CHASTE TREE

🎯 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 ↗
← 80641-0520-01 · Vacation 80641-0524-03 · Vacation →
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.