Home › NDC Lookup › Ingredients › Avobenzone, Homosalate, Octisalate And O... › 80641-0720-01
Vacation Lip Balm Avobenzone, Homosalate, Octisalate, and Octocrylene 3 g/100mL; 3 g/100mL; 4 g/100mL; 10 g/100mL Gel, 15 mL — NDC 80641-0720-01 package photo

Vacation Lip Balm Avobenzone, Homosalate, Octisalate, and Octocrylene 3 g/100mL; 3 g/100mL; 4 g/100mL; 10 g/100mL Gel, 15 mL

by Vacation INC. · 15 mL in 1 TUBE (80641-720-01)
NDC 80641-0720-01
🏷️ FDA NDC (as labeled) 80641-720-01 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) 80641-720-01
Product NDC 80641-720
11-digit billing NDC 80641072001
UNII G63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM
Application # M020
SPL Set ID 4ba8ed52-2f52-40b9-a810-8450f9b90778
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-15
Route TOPICAL
Dosage form GEL
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 80641-720-01 — 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 → 80641-0720-01. 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 marketedMar 2026
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 Lip Balm is a topical gel sunscreen product marketed as an over-the-counter monograph drug. It contains four ultraviolet (UV) filter ingredients: avobenzone, homosalate, octisalate, and octocrylene, which are commonly used together in sunscreen formulations to absorb and scatter UV radiation from the sun. This type of product is typically applied to the lips to help reduce sun exposure in that area.

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 H4N855PNZ1
    Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
  • UNII A7E6112E4N
    A form of vitamin E used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down, helping maintain stability and shelf life.
  • UNII A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • 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 12V64UPU6R
    A plant-based fat extracted from murumuru palm seeds. It acts as an emollient and thickener in topical formulations, helping create smooth texture and improve skin feel in creams and lotions.
  • 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 ZRA72DR3R7
    A waxy substance made from fatty acids and glycerin that acts as a binder and lubricant in tablets and capsules. It helps hold ingredients together and makes the medicine easier to swallow.
  • 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 QBS8A3XZGQ
    A synthetic oil made from diisostearyl alcohol and malic acid. It serves as an emollient and solvent in formulations, helping to dissolve and deliver active ingredients while improving texture and spreadability.
  • UNII X687XDK09L
    A clay mineral processed to carry positive charges, used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed throughout the product.
  • UNII 9A87HC7ROD
    A synthetic compound used as a plasticizer and conditioning agent in tablet coatings and film formulations. It helps make coatings flexible and improves how they cling to the tablet surface.
  • UNII I1MPW273QS
    A plant-derived oil used as an emollient and solvent in topical formulations. It helps soften the skin, improve product texture, and allow active ingredients to spread evenly across the skin.
  • 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 XOF597Q3KY
    A refined form of wax made from petroleum, microcrystalline wax is used in medicines as a coating agent, binder, and hardening ingredient. It helps give tablets and capsules their shape and protective outer layer.
  • UNII 461N1O614Y
    A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
  • UNII Q41S464P1R
    A synthetic peptide (short protein-like molecule) used in skincare and cosmetic formulations as an active conditioning ingredient to help improve skin texture and appearance. It may function as a humectant or skin-conditioning agent in topical products.
  • UNII RV743D216M
    A synthetic peptide derived from fatty acids and amino acids. It functions as a skin-conditioning agent and emollient in topical formulations, helping soften and smooth the product texture while supporting skin hydration.
  • UNII 8N725H4EFN
    A plant-derived oily substance made from plant sterols and fatty acids. It acts as an emollient and thickener to improve the texture and spreadability of the medication formulation.
  • UNII 1NA5AO9GH7
    A synthetic polymer derived from petroleum, polybutene is used as a binder and lubricant in solid medications to help hold ingredients together and improve the tablet or capsule's flow during manufacturing.
  • UNII DG195GP57P
    A synthetic emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients together and keeps them mixed throughout the product's shelf life.
  • UNII 8D08K3S51E
    Propylene carbonate is a clear liquid solvent derived from propylene. It helps dissolve or suspend active ingredients in liquid medicines and can improve how well the product flows and mixes.
  • UNII I4807BK602
    Saccharin sodium anhydrous is an artificial sweetener derived from saccharin that contains no water. It's added to medicines to improve taste and make them easier to swallow, especially in liquid formulations and chewable tablets.
  • 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 6W9PS8B71J
    Sorbitan monolaurate is a natural oil-derived emulsifier made from sorbitol and lauric acid. It helps mix oils and water-based ingredients together in the medicine so the formula stays uniform and smooth.
  • UNII 241ATL177A
    Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
  • 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 Q3Z4BCH099
    A manufactured wax made from refined petroleum or plant oils. It coats tablet surfaces to control how fast the medicine dissolves and releases, and improves how the tablet feels and looks.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII CHI530446X
    Vanillin is a natural or synthetic aromatic compound that gives vanilla flavor. It's used in medicines as a flavoring agent to mask bitter tastes and improve how the medicine tastes.

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

The official label also statesPhytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Diisostearyl Malate, Polybutene, Butyrospermum Parkii (Shea) Butter, Hydrogenated Polyisobutene, Microcrystalline Wax, Octyldodecanol, Flavor, Polyglyceryl-2 Diisostearate, Synthetic Wax, Disteardimonium Hectorite, Astrocaryum Murumuru Seed Butter, Vanillin, Cocos Nucifera (Coconut) Oil, Propylene Carbonate, Tocopheryl Acetate (Vitamin E), Hyaluronic Acid, Glycine Soja (Soybean) Oil, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Helianthus Annuus (Sunflower) Seed Oil, Sodium Saccharin, Ethylene Brassylate, Tocopherol, Musa Sapientum (Banana) Fruit Extract, C12-15 Alkyl Benzoate, Aloe Barbadensis (Aloe Vera) Leaf Extract, Sorbitan Laurate, C18-36 Acid Triglyceride, C18-36 Acid Glycol Ester, Titanium Dioxide (CI 77891)

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.
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 Lip Balm 3 g/100mL; 3 g/100mL; 4 g/100mL; 10 g/100mL 80641-0520-01 Vacation 15 ml — — FDA listed —
Vacation Lip Balm 3 g/100mL; 3 g/100mL; 4 g/100mL; 10 g/100mLthis 80641-0720-01 Vacation 15 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

🏛️
2026
On the market since
Mar 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.

🔬 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, and Octocrylene — the ingredient across all brands.

Top reported reactions

Skin Cancer58
Basal Cell Carcinoma21
Neoplasm Malignant21
Rash21
Malignant Melanoma19
Product Lot Number Issue12
Recalled Product Administered11

Age at onset

Infant1
Child2
Adolescent2
Adult42
Elderly19

Reporter sex

259 reports

Serious outcomes

Hospitalization15
Disabling8
Death5
Life-threatening3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 193 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
80641-0720-01 You're viewing this 15 mL in 1 TUBE (80641-720-01) 2026-03-15 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 80641-720-01, 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: 80641-0720-01, written without dashes as 80641072001. 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 80641-0720-01, the first segment (80641) is the labeler code FDA assigned to Vacation INC.; the middle segment (0720) 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.
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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 7 words ▾

Uses Helps prevent sunburn and chapped lips.

⏱️ Dosage and Administration 87 words ▾

Directions Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this 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–sleeved shirts, pants, hats, and sunglasses. Children under 6 months: ask a doctor.

⚠️ Warnings 33 words ▾

Warnings For external use only. Keep out of eyes. Stop use if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 14 words ▾

Other Information Protect the product in this container from excessive heat and direct sun.

🧪 Active Ingredient 10 words ▾

Active Ingredients Avobenzone (3.0%), Homosalate (3.0%), Octisalate (4.0%), Octocrylene (10.0%)

🧪 Inactive Ingredients 86 words ▾

Inactive Ingredients Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Diisostearyl Malate, Polybutene, Butyrospermum Parkii (Shea) Butter, Hydrogenated Polyisobutene, Microcrystalline Wax, Octyldodecanol, Flavor, Polyglyceryl-2 Diisostearate, Synthetic Wax, Disteardimonium Hectorite, Astrocaryum Murumuru Seed Butter, Vanillin, Cocos Nucifera (Coconut) Oil, Propylene Carbonate, Tocopheryl Acetate (Vitamin E), Hyaluronic Acid, Glycine Soja (Soybean) Oil, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Helianthus Annuus (Sunflower) Seed Oil, Sodium Saccharin, Ethylene Brassylate, Tocopherol, Musa Sapientum (Banana) Fruit Extract, C12-15 Alkyl Benzoate, Aloe Barbadensis (Aloe Vera) Leaf Extract, Sorbitan Laurate, C18-36 Acid Triglyceride, C18-36 Acid Glycol Ester, Titanium Dioxide (CI 77891)

🎯 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 ↗
← 80641-0620-01 · Vacation 80651-0093-00 · Diaperderm →
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.