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Cay Skin Isle Glow Body SPF 45 Avobenzone, Octisalate, Octocrylene 30 mg/mL; 50 mg/mL; 100 mg/mL Lotion

by Cay Skin, Inc. · 1 BOTTLE, PUMP in 1 CARTON (82657-003-01) / 100 mL in 1 BOTTLE, PUMP
NDC 82657-0003-01
🏷️ FDA NDC (as labeled) 82657-003-01 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) 82657-003-01
Product NDC 82657-003
11-digit billing NDC 82657000301
UNII G63QQF2NOX, 4X49Y0596W, 5A68WGF6WM
Application # M020
SPL Set ID db5f6bad-65ae-2b05-e053-2a95a90a8569
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-03-29
Route TOPICAL
Dosage form LOTION
Substance AVOBENZONE; OCTISALATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 82657-003-01 — 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 → 82657-0003-01. 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

LabelerCay Skin, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code82657
First marketedMar 2022
Product typeHuman Otc Drug
Portfolio11 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?

Cay Skin Isle Glow Body SPF 45 is a topical lotion marketed as an over-the-counter sunscreen product under FDA's monograph rules for sunscreen drugs. It contains three ultraviolet (UV) filters: avobenzone, octisalate, and octocrylene, which are typically combined to absorb and scatter UVA and UVB radiation from the sun. This type of product is commonly used to help reduce sun exposure to the skin.

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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 LU49E6626Q
    A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
  • UNII B423VGH5S9
    A natural fruit ingredient derived from apples, used as a flavoring agent and sweetener to improve taste and palatability of the medicine.
  • 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 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 59TL3WG5CO
    A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
  • UNII VT07D6X67O
    Cetyl phosphate is a waxy substance derived from fatty acids. It acts as an emulsifier to help mix oil and water-based ingredients, and may also serve as a thickener or stabilizer in creams and lotions.
  • UNII I670DAL4SZ
    A preservative that fights bacteria and fungi. It keeps medicines and topical products stable and safe from microbial contamination during storage and use.
  • UNII OQS23HUA1X
    A seaweed-derived natural thickener and gelling agent. In medicines, it forms a gel-like consistency to improve texture and help the product hold together, or to slow how quickly the body absorbs the medication.
  • 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 P7E6YFV72X
    Diisopropyl adipate is a clear, oily liquid derived from adipic acid. It acts as a plasticizer and solvent in medicines, helping soften coatings and improve how the drug dissolves or spreads in the body.
  • UNII J8T3X564IH
    A clear oily liquid derived from sebacic acid, used as a plasticizer and solvent in pharmaceutical coatings and films to improve flexibility and help active ingredients dissolve properly.
  • UNII 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • UNII XQQ9MKE2BJ
    Eicosyl povidone is a synthetic polymer derived from povidone with added long-chain fatty components. It functions as a solubilizer and absorption enhancer to help the medicine dissolve better and be absorbed more effectively by the body.
  • 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 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII AVM951ZWST
    Ferulic acid is a naturally occurring plant compound used as an antioxidant in medications. It helps prevent ingredient breakdown and maintain product stability during storage.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII WH8T92A065
    A fatty acid derivative made by combining stearic acid with glycerin and citric acid. It acts as an emulsifier to help mix oil and water-based ingredients, and also serves as a thickener in the medicine formulation.
  • UNII G5SU0BFK7O
    A synthetic compound made from lauryl alcohol and lactic acid. It works as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the medicine dissolves or spreads.
  • UNII 6O38V6B52O
    A plant-derived starch from lentils used as a filler and binder in tablets and capsules. It helps give the medicine its solid form and holds ingredients together during manufacturing.
  • UNII 2J5K7YCF9F
    A plant-derived substance from limonium coriarium used as a natural binder and thickening agent. It helps hold tablet or capsule ingredients together and adds bulk to the formulation.
  • UNII YK3DC63Y5M
    A mineral compound derived from natural or synthetic sources that acts as an anti-caking agent and flow aid. It helps prevent clumping and improves the powder's ability to flow smoothly during manufacturing and tablet formation.
  • 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 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • 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 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 OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII TU7HW0W0QT
    A salt derived from lactic acid, sodium lactate acts as a buffer and pH stabilizer in medicines. It helps maintain the product's acidity level and can also serve as a humectant to retain moisture.
  • UNII 469OTG57A2
    Sodium pyrrolidone carboxylate is a synthetic polymer derived from pyrrolidone chemistry. It functions as a solubilizer and binder in medications, helping dissolve poorly water-soluble drugs and hold tablet ingredients together.
  • UNII JB2MV9I3LS
    Stannous oxide is a tin-based compound used as a polishing agent in toothpaste formulations. It helps remove surface stains and create a smooth tooth surface during brushing.
  • 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 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 231473QB6R
    Watermelon is a fruit extract or flavoring agent. It's added to medicines to improve taste, making the product more palatable, especially for children or medications with unpleasant flavors.

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

The official label also statesWater, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Sodium Potassium Aluminum Silicate, Diisopropyl Sebacate, Diisopropyl Adipate, Lauryl Lactate, Mica, Propanediol, Glyceryl Stearate, VP/Eicosene Copolylmer, Chondrus Crispus Extract, Limonium Gerberi Extract, Ferulic Acid, Citrullus Lanatus (Watermelon) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Lens Esculents (Lentil) Fruit Extract, Helianthus Annuus (Sunflower) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Glycerin, Caprylic/Capric Triglyceride, Cetyl Phosphate, Glyceryl Stearate Citrate, Silica, Ethylene Brassylate, Caprylyl Glycol, 1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Sodium Lactate, Sodium PCA, Sodium Benzoate, Potassium Sorbate, Disodium EDTA, Chlorphenesin, Synthetic Fluorphlogopite, Tin Oxide, CI 77891 (Titanium Dioxide), CI 77491 (Iron Oxides)

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
I KNOW Very Necessary Broad Spectrum SPF-40 Moisturizing Cream 30 mg/mL; 50 mg/mL; 100 mg/mL 82188-0222-00 Thirty7 1 jar — — FDA listed —
Walgreens Daily Facial Moisturizer with Broad Spectrum SPF 30 Sunscreen 30 mg/mL; 50 mg/mL; 100 mg/mL 00363-0172-04 WALGREEN 1 bottle — — FDA listed —
Sun Bum Daily Glow Tinted Sunscreen Moisturizer Broad Spectrum SPF 30 30 mg/mL; 50 mg/mL; 100 mg/mL 69039-0668-01 Sun 1 tube — — FDA listed —
Cay Skin Isle Glow Body SPF 45 30 mg/mL; 50 mg/mL; 100 mg/mLthis 82657-0003-01 Cay 1 bottle — — FDA listed —
Walgreens Broad Spectrum SPF 40 Radiant Facial Sunscreen 30 mg/mL; 50 mg/mL; 100 mg/mL 00363-0364-17 WALGREEN 1 tube — — FDA listed —
HEB Glow 40 Tinted Sunscreen Face Primer 30 mg/mL; 50 mg/mL; 100 mg/mL 37808-0154-09 H.E.B. 89 ml — — FDA listed —
Pacto Refreshing Sunscreen Broad Spectrum SPF 50 30 mg/mL; 50 mg/mL; 100 mg/mL 87506-0974-00 Mynd 75 ml — — FDA listed —
Kroger Shimmer Sunscreen Hydrating SPF 40 30 mg/mL; 50 mg/mL; 100 mg/mL 30142-0241-09 THE 1 tube — — 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
Mar 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
82657-0003-01 You're viewing this 1 BOTTLE, PUMP in 1 CARTON (82657-003-01) / 100 mL in 1 BOTTLE, PUMP 2022-03-29 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 — Not published for this NDC No photo available yet for this listing.
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 82657-003-01, 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: 82657-0003-01, written without dashes as 82657000301. 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 82657-0003-01, the first segment (82657) is the labeler code FDA assigned to Cay Skin, Inc.; the middle segment (0003) 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 Cay Skin, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cay Skin, 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 29 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 106 words ▾

Directions Adults and children over 6 months of age: Apply liberally 15 minutes before sun exposure. Reapply: at least every 2 hours; immediately after towel drying. Use a water resistant sunscreen if swimming or sweating.

Children under 6 months of age: ask a doctor. Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging.

To decrease this risk regularly use a sunscreen with a Broad Spectrum SPF value 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.

⚠️ Warnings 57 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 consult a doctor if skin rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 8 words ▾

Active ingredients Avobenzone 3%, Octisalate 5%, Octocrylene 10%

🧪 Inactive Ingredients 100 words ▾

Inactive ingredients Water, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Sodium Potassium Aluminum Silicate, Diisopropyl Sebacate, Diisopropyl Adipate, Lauryl Lactate, Mica, Propanediol, Glyceryl Stearate, VP/Eicosene Copolylmer, Chondrus Crispus Extract, Limonium Gerberi Extract, Ferulic Acid, Citrullus Lanatus (Watermelon) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Lens Esculents (Lentil) Fruit Extract, Helianthus Annuus (Sunflower) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Glycerin, Caprylic/Capric Triglyceride, Cetyl Phosphate, Glyceryl Stearate Citrate, Silica, Ethylene Brassylate, Caprylyl Glycol, 1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Sodium Lactate, Sodium PCA, Sodium Benzoate, Potassium Sorbate, Disodium EDTA, Chlorphenesin, Synthetic Fluorphlogopite, Tin Oxide, CI 77891 (Titanium Dioxide), CI 77491 (Iron Oxides)

🎯 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 ↗
← 82657-0002-01 · Cay 82657-0007-01 · Cay →
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.