Home › NDC Lookup › Ingredients › Homosalate, Octisalate › 62217-0043-74
FOTE CABANA BEACH CLUB WITH BLOOD ORANGE AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREEN HOMOSALATE, OCTISALATE 70 mg/g; 50 mg/g Aerosol, Spray, 76.5 g — NDC 62217-0043-74 package photo

FOTE CABANA BEACH CLUB WITH BLOOD ORANGE AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREEN HOMOSALATE, OCTISALATE 70 mg/g; 50 mg/g Aerosol, Spray, 76.5 g

by FRUIT OF THE EARTH, INC. · 76.5 g in 1 CAN (62217-043-74)
NDC 62217-0043-74
🏷️ FDA NDC (as labeled) 62217-043-74 billing pads the product segment with a zero
This package
Contains76.5 g Pack sizes2 compare ↓
Also comes in: 156 g 62217-0043-37
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) 62217-043-74
Product NDC 62217-043
11-digit billing NDC 62217004374
UNII V06SV4M95S, 4X49Y0596W
Application # M020
SPL Set ID 13325a2a-f7f8-4019-acbb-205fd5dd13a5
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-01-15
Route TOPICAL
Dosage form AEROSOL, SPRAY
Substance HOMOSALATE; OCTISALATE
Why two NDCs? The FDA registers this code as 62217-043-74 — 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 → 62217-0043-74. 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

LabelerFRUIT OF THE EARTH, INC.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code62217
First marketedJan 2019
Product typeHuman Otc Drug
Portfolio37 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?

This is an over-the-counter sunscreen spray marketed as a tanning product. It contains two UV filter ingredients, homosalate and octisalate, which are commonly used in sunscreens to absorb ultraviolet radiation and help protect skin from sun exposure. The product is applied topically by spraying it onto the skin. This is an OTC monograph drug, meaning it is made under FDA's established rules for sunscreen products rather than as an individually approved application.

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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII JU3XHR8VWK
    A synthetic plastic polymer used as a film-coating agent. It forms a protective layer around tablets or capsules to control how and where the medicine dissolves in your digestive system.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII UZH29XGA8G
    Lime oil is a natural fragrant liquid extracted from lime fruit peel. It's used in medicines as a flavoring agent to mask bitter or unpleasant tastes, making the medicine more pleasant to take.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII AKN3KSD11B
    Orange oil obtained by cold pressing orange peel. It serves as a flavoring agent and fragrance in medicines to improve taste and aroma.
  • UNII AZQ08K38Z1
    A synthetic oily liquid derived from salicylic acid. It works as an emollient and penetration enhancer in topical formulations, helping active ingredients absorb into skin while conditioning and softening the application area.

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

The official label also statesalcohol denat., mineral oil, tridecyl salicylate, fragrance, acrylates/octylacrylamide copolymer, tocopheryl acetate, citrus sinensis (blood orange) oil, citrus aurantium dulcis (orange) peel oil, citrus aurantifolia (lime) 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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 156 g
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
Fote Cabana Beach Club With Blood Orange And Essential Oils Spf 8 Dry Tanning Sunscreen 70 mg/g; 50 mg/gthis 62217-0043-74 FRUIT 76.5 g — — 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

🏛️
2019
On the market since
Jan 2019
📍
2026
Currently FDA-listed
7 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 HOMOSALATE, OCTISALATE — the ingredient across all brands.

Top reported reactions

Skin Cancer65
Rash56
Pruritus41
Erythema36
Pain31
Neoplasm Malignant28
Basal Cell Carcinoma27

Age at onset

Infant1
Child8
Adolescent5
Adult76
Elderly56

Reporter sex

823 reports
Male · 33%
Female · 67%

Serious outcomes

Hospitalization125
Disabling26
Death25
Life-threatening19
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 238 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
62217-0043-37 156 g in 1 CAN (62217-043-37) 2019-01-15 Active
62217-0043-74 You're viewing this 76.5 g in 1 CAN (62217-043-74) 2019-04-03 Active

Pack size FAQ

What quantity is in NDC 62217-0043-74?
NDC 62217-0043-74 contains 76.5 g — 76.5 g in 1 can.
What is the difference between NDC 62217-0043-74 and NDC 62217-0043-37?
Both are FOTE CABANA BEACH CLUB WITH BLOOD ORANGE AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREEN HOMOSALATE, OCTISALATE 70 mg/g; 50 mg/g Aerosol, Spray — the drug itself is identical. NDC 62217-0043-74 is the 76.5 g package, while NDC 62217-0043-37 is the 156 g package.
What NDC number is used to bill for this package of FOTE CABANA BEACH CLUB WITH BLOOD ORANGE AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREEN HOMOSALATE, OCTISALATE 70 mg/g; 50 mg/g Aerosol, Spray?
Bill NDC 62217-0043-74 — the 11-digit billing format is 62217004374. 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 62217-043-74, 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: 62217-0043-74, written without dashes as 62217004374. 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 62217-0043-74, the first segment (62217) is the labeler code FDA assigned to FRUIT OF THE EARTH, INC.; the middle segment (0043) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (74) 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 FRUIT OF THE EARTH, 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 156 g (62217-0043-37). 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?
FRUIT OF THE EARTH, 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 and Cautions ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 4 words ▾

Uses helps prevent sunburn

⏱️ Dosage and Administration 76 words ▾

Directions Spray liberally and spread evenly by hand 15 minutes before sun exposure Hold can 4-6 inches away from the skin to apply Do not spray directly into face. Spray into hands then apply to face Do not apply in windy conditions Use in a well-ventilated area. Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours Children under 6 months of age: Ask a doctor

⚠️ Warnings and Cautions 17 words ▾

FLAMMABLE: do not use near heat, flame or while smoking avoid long term storage above 104°F (40°C)

⚠️ Warnings 37 words ▾

Warnings Skin Cancer/Skin Aging Alert : Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

📦 Storage and Handling 23 words ▾

Other information protect the product in this container from excessive heat and direct sun may stain or damage some fabrics, materials or surfaces

🧪 Active Ingredient 6 words ▾

Active ingredients Homosalate 7.0%, Octisalate 5.0%

🧪 Inactive Ingredients 28 words ▾

Inactive ingredients alcohol denat., mineral oil, tridecyl salicylate, fragrance, acrylates/octylacrylamide copolymer, tocopheryl acetate, citrus sinensis (blood orange) oil, citrus aurantium dulcis (orange) peel oil, citrus aurantifolia (lime) 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 ↗
← 62217-0041-37 · FRUIT 62217-0061-37 · Fruit →
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.