Home › NDC Lookup › Ingredients › Avobenzone, Octinoxate, Octisalate And O... › 49527-0081-01
🧴image loading
(from DailyMed)

CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER AVOBENZONE, OCTINOXATE, OCTISALATE, and OXYBENZONE 30 mg/mL; 74 mg/mL; 50 mg/mL; 20 mg/mL Lotion

by CLINIQUE LABORATORIES LLC · 1 TUBE in 1 CARTON (49527-081-01) / 100 mL in 1 TUBE
NDC 49527-0081-01
🏷️ FDA NDC (as labeled) 49527-081-01 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) 49527-081-01
Product NDC 49527-081
11-digit billing NDC 49527008101
UNII G63QQF2NOX, 4Y5P7MUD51, 4X49Y0596W, 95OOS7VE0Y
Application # M020
SPL Set ID 2e9463df-1c71-465f-9820-6cedefe07ad7
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-07-21
Route TOPICAL
Dosage form LOTION
Substance AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE
Why two NDCs? The FDA registers this code as 49527-081-01 — 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 → 49527-0081-01. 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

LabelerCLINIQUE LABORATORIES LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code49527
First marketedJul 2021
Product typeHuman Otc Drug
Portfolio61 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 lotion moisturizer designed for topical use on the face. It contains four ultraviolet (UV) filters: avobenzone, octinoxate, octisalate, and oxybenzone, which are commonly used in sunscreen products to help protect skin from sun exposure. The product is marketed as a broad-spectrum sunscreen moisturizer for men and is regulated as an over-the-counter monograph drug, meaning it follows established FDA guidelines for sunscreen ingredients and formulations rather than being individually reviewed.

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 5PWM7YLI7R
    Barley is a grain plant. It may be used in some medicines as a filler or binder to add bulk and help hold the tablet or capsule together.
  • 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 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 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 09FUA47KNA
    Cetearyl glucoside is a plant-derived surfactant made from vegetable oils and glucose. It helps oils and water mix together in creams and lotions, and can also soften and smooth the skin feel of the product.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII UC9PE95IBP
    A synthetic compound that works as a preservative and antimicrobial agent in medicines. It helps prevent bacterial and fungal growth, extending the shelf life of liquid formulations like eye drops and topical solutions.
  • UNII 97C5T2UQ7J
    Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
  • UNII YY7C30VXJT
    A natural plant extract from cucumber that adds flavor and freshness to medicines. It may also serve as a moisturizing agent or mild preservative in topical or oral formulations.
  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • 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 554N82UWVW
    A synthetic oily substance made from dipentaerythritol combined with caprylic and capric acids. It functions as an emollient and skin-conditioning agent in topical formulations, helping to soften and smooth the product texture.
  • 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 I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 482WYF7XLC
    A plant-based powder made from sunflower seeds left over after oil extraction. It acts as a filler and binder to give the tablet its structure and help hold ingredients together.
  • UNII KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
  • UNII UG00KM4WR7
    A plastic polymer used as a container material and film coating. It helps protect the medicine from moisture and air exposure during storage and shipping.
  • UNII H1109Z9J4N
    A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
  • UNII A8289P68Y2
    Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
  • UNII N72LMW566G
    A synthetic cleansing agent derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oil and water-based ingredients in liquid medicines, acting as an emulsifier and solubilizer.
  • UNII 6HQ855798J
    Laureth-4 is a synthetic detergent made from lauryl alcohol and ethylene oxide. It acts as an emulsifier and solubilizer, helping blend oil and water-based ingredients and improve how the body absorbs the active drug.
  • UNII 9913I24QEE
    A live beneficial bacterium added to some medicines and supplements. It serves as a probiotic ingredient intended to support gut health and digestion.
  • UNII 5LKW3C543X
    A synthetic oily liquid derived from neopentyl glycol and heptanoic acid. It serves as an emollient and solvent in formulations, helping to dissolve or suspend active ingredients and improve the texture and spreadability of topical products.
  • UNII JD797EF70J
    A synthetic fatty alcohol made from oils, oleth-10 works as an emulsifier and solubilizer in medicines. It helps mix water and oil-based ingredients together and keeps them blended throughout the product's shelf life.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • 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 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII U783H9JHWY
    A synthetic oily liquid used as an emulsifier and solvent in medicines. It helps blend oil and water-based ingredients together and improves how active drugs dissolve and spread through the formulation.
  • UNII VU10KU4B9S
    A finely powdered mineral form of silicon dioxide with a chemical coating that reduces moisture absorption. Used as a glidant and anti-caking agent to improve powder flow and prevent clumping in solid medications.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII A8OE252M6L
    A synthetic fatty substance made from plant or mineral oils. It works as a lubricant and emollient in medicines, helping pills slide smoothly during manufacturing and improving how the product feels or spreads.
  • UNII FY36J270ES
    A synthetic chemical compound used as a plasticizer in film coatings. It makes tablet or capsule coatings flexible and durable so they don't crack or break during handling and storage.
  • UNII 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
  • 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 Y3NG9WF08W
    Zeolite A is a microporous mineral powder that acts as a drying agent and absorbent in medicines. It removes moisture to keep solid formulations dry and stable during storage.

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

The official label also stateswater\aqua\eau•butylene glycol•dimethicone•neopentyl glycol diheptanoate•cetearyl alcohol•peg-100 stearate•silica•hordeum vulgare (barley) extract\extrait d'orge•algae extract•cucumis sativus (cucumber) fruit extract•helianthus annuus (sunflower) seedcake•cholesterol•cetearyl glucoside•propylene glycol dicaprate•tridecyl trimellitate•hydrogenated lecithin•stearyl alcohol•zeolite•lactobacillus ferment•cetrimonium chloride•tridecyl stearate•isododecane•dipentaerythrityl hexacaprylate/hexacaprate•pvp•oleth-10•laureth-4•laureth-23•caprylyl glycol•hexylene glycol•polyethylene•tromethamine•carbomer•sodium citrate•disodium edta•potassium sorbate•phenoxyethanol•yellow 5 (ci 19140)•yellow 6 (ci 15985)•red 33 (ci 17200) [iln43259]

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
Clinique For Men Broad Spectrum Spf 21 Moisturizer 30 mg/mL; 74 mg/mL; 50 mg/mL; 20 mg/mLthis 49527-0081-01 CLINIQUE 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

🏛️
2021
On the market since
Jul 2021
📍
2026
Currently FDA-listed
5 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 AVOBENZONE, OCTINOXATE, OCTISALATE, and OXYBENZONE — the ingredient across all brands.

Top reported reactions

Skin Exfoliation1

Reporter sex

1 reports
Female · 100%
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
49527-0081-01 You're viewing this 1 TUBE in 1 CARTON (49527-081-01) / 100 mL in 1 TUBE 2021-07-21 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 49527-081-01, 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: 49527-0081-01, written without dashes as 49527008101. 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 49527-0081-01, the first segment (49527) is the labeler code FDA assigned to CLINIQUE LABORATORIES LLC; the middle segment (0081) 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 CLINIQUE LABORATORIES LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CLINIQUE LABORATORIES LLC 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 4 words ▾

Use helps prevent sunburn

⏱️ Dosage and Administration 96 words ▾

Directions For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every two 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 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 children under 6 months of age: ask a doctor

⚠️ Warnings 56 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 product is 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% Octinoxate 7.4% Octisalate 5.0% Oxybenzone 2.0%

🧪 Inactive Ingredients 45 words ▾

Inactive ingredients water\aqua\eau•butylene glycol•dimethicone•neopentyl glycol diheptanoate•cetearyl alcohol•peg-100 stearate•silica•hordeum vulgare (barley) extract\extrait d'orge•algae extract•cucumis sativus (cucumber) fruit extract•helianthus annuus (sunflower) seedcake•cholesterol•cetearyl glucoside•propylene glycol dicaprate•tridecyl trimellitate•hydrogenated lecithin•stearyl alcohol•zeolite•lactobacillus ferment•cetrimonium chloride•tridecyl stearate•isododecane•dipentaerythrityl hexacaprylate/hexacaprate•pvp•oleth-10•laureth-4•laureth-23•caprylyl glycol•hexylene glycol•polyethylene•tromethamine•carbomer•sodium citrate•disodium edta•potassium sorbate•phenoxyethanol•yellow 5 (ci 19140)•yellow 6 (ci 15985)•red 33 (ci 17200) [iln43259]

🎯 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 ↗
← 49527-0080-01 · CLINIQUE 49527-0082-01 · CLINIQUE →
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.