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DECORTE SUN SHELTER MULTI PROTECTION Sunscreen SPF 50 Broad Spectrum AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE 10 mg/mL; 73 mg/mL; 74.9 mg/mL; 30 mg/mL Lotion

by KOS America, Inc. · 1 TUBE in 1 CARTON (66820-0600-1) / 60 mL in 1 TUBE
NDC 66820-0600-01
🏷️ FDA NDC (as labeled) 66820-0600-1 billing pads the package segment with a zero
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) 66820-0600-1
Product NDC 66820-0600
11-digit billing NDC 66820060001
UNII 4X49Y0596W, V06SV4M95S, 4Y5P7MUD51, G63QQF2NOX
Application # M020
SPL Set ID 2b41c17d-1394-0c2f-e063-6394a90a0c49
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-01
Route TOPICAL
Dosage form LOTION
Substance OCTISALATE; HOMOSALATE; OCTINOXATE; AVOBENZONE
Why two NDCs? The FDA registers this code as 66820-0600-1 — a 5-4-1 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 package segment → 66820-0600-01. 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

LabelerKOS America, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code66820
First marketedMay 2025
Product typeHuman Otc Drug
Portfolio3 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?

Decorte Sun Shelter Multi Protection is a topical lotion sunscreen containing four ultraviolet light absorbers: avobenzone, homosalate, octinoxate, and octisalate. These ingredients are typically used together as chemical filters to absorb UV radiation and help protect skin from sun damage. The product is formulated as an over-the-counter monograph drug and is labeled as broad spectrum SPF 50, meaning it is intended to filter both UVA and UVB rays.

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 89T13OHQ2B
    A natural gel-like substance derived from seaweed. In medications, agar acts as a binder and thickener to give solid form to capsules or tablets, and can help control how quickly the medicine dissolves and releases in your body.
  • UNII V5VD430YW9
    A plant-derived substance from the aloe vera leaf. Used in medicines as a natural flavor, skin-soothing agent in topical products, and sometimes as a mild laxative ingredient in oral formulations.
  • UNII 47143LT58A
    A synthetic form of vitamin C that acts as an antioxidant. It prevents other ingredients in the medicine from breaking down or discoloring when exposed to air or light.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • 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 69W9UMG3P8
    A synthetic oily compound used as a plasticizer and solvent in medicines. It helps soften and improve flexibility of coatings on tablets and capsules, and aids in dissolving or dispersing active ingredients in liquid formulations.
  • UNII E107L85C40
    Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • 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 RMB44WO89X
    Hydroxyproline is an amino acid derived from collagen. In medications, it serves as a structural component or filler that may help provide stability and texture to the formulation.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 918X1OUF1E
    Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
  • UNII X1U1U0N90J
    A plant extract from common mallow flowers used in some formulations as a natural flavoring agent and to add color. It may also help soothe irritation in throat lozenges or similar products.
  • UNII 196OC77688
    A synthetic plastic polymer used as a film-coating material on tablets and capsules. It helps protect the medication, control how fast it dissolves, and improve appearance.
  • UNII Z944H5SN0H
    A plant-based thickening agent derived from cellulose. It acts as a binder to hold tablet ingredients together and as a thickener in liquid formulations to achieve the right consistency.
  • 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 WQP0973914
    A liquid emulsifier made from polyethylene glycol and plant-derived fatty acids. It helps mix oil and water ingredients together and improves how the medicine spreads or dissolves in the body.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII IJ67X351P9
    A natural plant extract from rosemary leaves used as a preservative to help prevent oils and fats in the medicine from spoiling or becoming rancid during storage.
  • UNII 8LGU7VM393
    Rosemary leaf oil is a natural aromatic oil extracted from rosemary plants. It's used in medicines as a flavoring agent and preservative to help protect the product from spoilage.
  • UNII 7C98FKB43H
    Sodium acrylate is a synthetic polymer (plastic-like material) used as a superabsorbent and thickening agent in medicines. It helps control the consistency and release of active ingredients, particularly in gel or semi-solid formulations.
  • UNII 06XEA2VD56
    Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
  • 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 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.

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

The official label also statesWATER/AQUA/EAU, BUTYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, DIETHYLHEXYL SUCCINATE, CYCLOPENTASILOXANE, PENTYLENE GLYCOL, DEXTRIN PALMITATE, GLYCERIN, ALOE BARBADENSIS LEAF EXTRACT, ASCORBYL TETRAISOPALMITATE, HYDROLYZED COLLAGEN, HYDROXYPROLINE, MALVA SYLVESTRIS (MALLOW) FLOWER/LEAF/STEM EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF WATER, TOCOPHEROL. ACRYLATES/DIMETHICONE COPOLYMER, AGAR, BHT, DIPROPYLENE GLYCOL, HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER, ISOHEXADECANE, OCTYLDODECANOL, PEG-60 GLYCERYL ISOSTEARATE, POLYSORBATE 80, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SORBITAN OLEATE, XANTHAN GUM, PHENOXYETHANOL, FRAGRANCE (PARFUM).

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
DECORTE SUN SHELTER MULTI PROTECTION Sunscreen SPF 50 Broad Spectrum 10 mg/mL; 73 mg/mL; 74.9 mg/mL; 30 mg/mLthis 66820-0600-01 KOS 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

🏛️
2025
On the market since
May 2025
📍
2026
Currently FDA-listed
1 year 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, HOMOSALATE, OCTINOXATE, OCTISALATE — the ingredient across all brands.

Top reported reactions

Drug Hypersensitivity1
Eye Irritation1
Suspected Counterfeit Product1

Reporter sex

0 reports
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 1 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
66820-0600-01 You're viewing this 1 TUBE in 1 CARTON (66820-0600-1) / 60 mL in 1 TUBE 2025-05-01 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 66820-0600-1, 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: 66820-0600-01, written without dashes as 66820060001. 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 66820-0600-01, the first segment (66820) is the labeler code FDA assigned to KOS America, Inc.; the middle segment (0600) 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 KOS America, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
KOS America, 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 📋 Description
🎯 Indications and Usage 68 words ▾

Uses Helps prevent sunburn Use as the final step in your morning skin care routine or before makeup. Apply generously and evenly before sun exposure. Reducing the amount of application will lower the level of protection significantly. For removal, use daily cleanser. Avoid contact with clothing and other textiles, as direct contact may stain. If clothing is stained, wash with detergent. Do not use chlorine bleach on stains.

⏱️ Dosage and Administration 98 words ▾

Directions Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply 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 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 wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor

⚠️ Warnings 5 words ▾

Warnings For external use only

🧪 Active Ingredient 10 words ▾

Active Ingredients Homosalate 7.30% Octisalate 1.00% Avobenzone 3.00% Octinoxate 7.49%

🧪 Inactive Ingredients 70 words ▾

Inactive Ingredients WATER/AQUA/EAU, BUTYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, DIETHYLHEXYL SUCCINATE, CYCLOPENTASILOXANE, PENTYLENE GLYCOL, DEXTRIN PALMITATE, GLYCERIN, ALOE BARBADENSIS LEAF EXTRACT, ASCORBYL TETRAISOPALMITATE, HYDROLYZED COLLAGEN, HYDROXYPROLINE, MALVA SYLVESTRIS (MALLOW) FLOWER/LEAF/STEM EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF WATER, TOCOPHEROL. ACRYLATES/DIMETHICONE COPOLYMER, AGAR, BHT, DIPROPYLENE GLYCOL, HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER, ISOHEXADECANE, OCTYLDODECANOL, PEG-60 GLYCERYL ISOSTEARATE, POLYSORBATE 80, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SORBITAN OLEATE, XANTHAN GUM, PHENOXYETHANOL, FRAGRANCE (PARFUM).

🎯 Purpose 2 words ▾

Purpose Sunscreen

📋 Description 24 words ▾

A sunscreen that protects skin from harmful environmental factors including UVA/UVB rays and dryness. Its lightweight, comfortable texture leaves skin hydrated, supple and radiant.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 66820-0500-01 · KOS 66824-0001-01 · Home →
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.