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Vacation Grand Cuvee Shimmer SPF 30 Avobenzone, Homosalate, Octisalate, and Octocrylene 3 g/100mL; 5.1 g/100mL; 5 g/100mL; 8.5 g/100mL Oil, 147 mL — NDC 80641-0525-03 package photo

Vacation Grand Cuvee Shimmer SPF 30 Avobenzone, Homosalate, Octisalate, and Octocrylene 3 g/100mL; 5.1 g/100mL; 5 g/100mL; 8.5 g/100mL Oil, 147 mL

by Vacation INC. · 147 mL in 1 BOTTLE, PUMP (80641-525-03)
NDC 80641-0525-03
🏷️ FDA NDC (as labeled) 80641-525-03 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) 80641-525-03
Product NDC 80641-525
11-digit billing NDC 80641052503
UNII G63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM
UPC 0380641003456
Application # M020
SPL Set ID e0b3d90b-ba56-43e5-aa68-8e5f473628ff
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 OIL
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 80641-525-03 — 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 → 80641-0525-03. 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 Grand Cuvee Shimmer SPF 30 is a topical oil sunscreen marketed under FDA's over-the-counter drug monograph rules. It contains four UV-filtering agents (avobenzone, homosalate, octisalate, and octocrylene) that are typically used together to absorb ultraviolet light and help protect skin from sun damage. This product is designed to be applied to the skin as an oil formulation with a sun protection factor of 30.

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 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 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 4V59G5UW9X
    Argan oil is a plant-derived oil from argan tree kernels. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
  • 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 R6995U1QSX
    A plant extract from the bark of the Biancaea sappan tree, traditionally used in herbal preparations. In medicines, it may serve as a natural colorant, flavoring agent, or botanical ingredient contributing to the product's formulation.
  • 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 4MM76N4WMY
    A synthetic glass-like mineral compound containing calcium, sodium, and boron. Used as a colorant, opacifying agent, and filler in medicines to provide white color, improve appearance, and add bulk to tablets or capsules.
  • 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 89B2BSF9I3
    A synthetic compound made by chemically combining corn dextrin (a starch derivative) with palmitic acid. It acts as a binder and flow agent, helping hold tablet ingredients together and improve powder handling during manufacturing.
  • 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 G7036X8B5H
    A dark iron compound that gives medicine its color. Used as a colorant in tablets and capsules to help identify the medication and make it visually distinctive.
  • UNII 930MLC8XGG
    A plant oil extracted from grape seeds, used as an emollient and solvent in medicines. It helps dissolve active ingredients and improve the texture and absorption of topical or liquid formulations.
  • 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 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • 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 C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII V8A1AW0880
    Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
  • 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 5M26W7T072
    Persic oil is a natural oil derived from peach kernels. It's used in medicines as an emollient and solvent to help soften formulations and improve how the product spreads or absorbs.
  • UNII 65UEH262IS
    Safflower oil is a plant-based oil extracted from safflower seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and sometimes as an emollient to improve texture.
  • UNII WDO4TLS35F
    A plant-based oil extracted from marula tree seeds, used as an emollient and skin-conditioning agent in topical formulations to help soften and protect the skin surface.
  • UNII O88E196QRF
    Sheanut oil is a natural fat extracted from shea nuts grown in Africa. It's used in medicines as an emollient, lubricant, and binding agent to improve texture, help ingredients mix smoothly, and keep the product stable.
  • 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 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 KM7N50LOS6
    Tin oxide is an inorganic mineral compound used in medicines as a colorant and opacifying agent. It provides white or off-white color to tablets, capsules, and coatings while helping make formulations less transparent.
  • 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 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 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.

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

The official label also statesArgania Spinosa (Argan) Kernel Oil, Beta-Sitosterol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, C12-15 Alkyl Benzoate, Caesalpinia Sappan Bark Extract, Calcium Sodium Borosilicate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Dextrin Palmitate, Dimethicone, Ethyl Ferulate, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Hyaluronic Acid, Iron Oxides, Mica, Musa Paradisiaca (Banana) Fruit Extract, Palmitoyl Tripeptide-1, Prunus Persica (Peach) Kernel Oil, Sclerocarya Birrea (Marula) Kernel Oil, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Squalene, Tin Oxide, Titanium Dioxide, Tocopherol (Vitamin E), Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Vitis Vinifera (Grape) Seed Oil

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 eachPer 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 Grand Cuvee Shimmer SPF 30 3 g/100mL; 5.1 g/100mL; 5 g/100mL; 8.5 g/100mLthis 80641-0525-03 Vacation 147 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
Male · 33%
Female · 67%

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
80641-0525-03 You're viewing this 147 mL in 1 BOTTLE, PUMP (80641-525-03) 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 80641-525-03, 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: 80641-0525-03, written without dashes as 80641052503. 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 80641-0525-03, the first segment (80641) is the labeler code FDA assigned to Vacation INC.; the middle segment (0525) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 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 92 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-sleeved shirts, pants, hats, and sunglasses Children under 6 months of age: ask a doctor.

⚠️ Warnings 54 words ▾

Warnings 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. 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 (5.1%), Octisalate (5.0%), Octocrylene (8.5%)

🧪 Inactive Ingredients 91 words ▾

Inactive Ingredients Argania Spinosa (Argan) Kernel Oil, Beta-Sitosterol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, C12-15 Alkyl Benzoate, Caesalpinia Sappan Bark Extract, Calcium Sodium Borosilicate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Dextrin Palmitate, Dimethicone, Ethyl Ferulate, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Hyaluronic Acid, Iron Oxides, Mica, Musa Paradisiaca (Banana) Fruit Extract, Palmitoyl Tripeptide-1, Prunus Persica (Peach) Kernel Oil, Sclerocarya Birrea (Marula) Kernel Oil, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Squalene, Tin Oxide, Titanium Dioxide, Tocopherol (Vitamin E), Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Vitis Vinifera (Grape) Seed Oil

🎯 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 ↗
← 80641-0524-03 · Vacation 80641-0620-01 · 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.