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SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE 30 mg/mL; 70 mg/mL; 35 mg/mL; 45 mg/mL Cream — NDC 49527-0083-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE 30 mg/mL; 70 mg/mL; 35 mg/mL; 45 mg/mL Cream — NDC 49527-083-03 (Billing 49527-0083-03)

by CLINIQUE LABORATORIES LLC · 1 JAR in 1 CARTON / 15 mL in 1 JAR

This is a package of SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE 30 mg/mL; 70 mg/mL; 35 mg/mL; 45 mg/mL Cream from CLINIQUE LABORATORIES LLC, marketed since May 2023 and currently FDA-listed.

NDC 49527-0083-03
🏷️ FDA NDC (as labeled) 49527-083-03 billing pads the product segment with a zero
This package
Contains15 mL in 1 jar Pack sizes5 compare ↓
Product page 49527-0083-01 Also comes in: 50 mL 49527-083-01 75 mL 49527-083-02 5 mL 49527-083-04 30 mL 49527-083-05
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 49527-083-03 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
49527 labeler · 083 product · 03 package
Package marketed since
May 12, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0192333163498
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49527-083-03
Product NDC 49527-083
11-digit billing NDC 49527008303
UNII G63QQF2NOX, V06SV4M95S, 4Y5P7MUD51, 4X49Y0596W
UPC 0192333163498
Application # M020
SPL Set ID fb841fd7-0c78-01a1-e053-6394a90a4382
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-05-12
Route TOPICAL
Dosage form CREAM
Substance AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE
Why two NDCs? The FDA registers this code as 49527-083-03 — 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 → 49527-0083-03. 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.

Clinical

🧪 What is this product?

Smart Clinical Repair Broad Spectrum SPF 30 is a topical cream sunscreen marketed as an over-the-counter monograph product. It contains four UV-filtering compounds (avobenzone, homosalate, octinoxate, and octisalate) that work together to absorb ultraviolet light from the sun. This type of product is typically used to help protect exposed skin from UV radiation during sun exposure.

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.

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.
Try another pack size: 50 mL 75 mL 5 mL 30 mL
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
49527-0083-01 49527-083-01 Main listing 1 JAR in 1 CARTON / 50 mL in 1 JAR 2023-05-12 — Active
49527-0083-02 49527-083-02 1 JAR in 1 CARTON / 75 mL in 1 JAR 2023-05-12 — Active
49527-0083-03 You're viewing this 1 JAR in 1 CARTON / 15 mL in 1 JAR 2023-05-12 — Active
49527-0083-04 49527-083-04 1 JAR in 1 CARTON / 5 mL in 1 JAR 2023-05-12 — Active
49527-0083-05 49527-083-05 1 JAR in 1 CARTON / 30 mL in 1 JAR 2023-05-12 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 jar in 1 carton / 15 ml in 1 jar.
What NDC number is used to bill for this package of SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE 30 mg/mL; 70 mg/mL; 35 mg/mL; 45 mg/mL Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Smart Clinical Repair Broad Spectrum Spf 30 30 mg/mL; 70 mg/mL; 35 mg/mL; 45 mg/mLthis 49527-0083-03 CLINIQUE 1 jar — — 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

🏛️
2023
On the market since
May 2023
📍
2026
Currently FDA-listed
3 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.

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 BK1IU07GKF
    A steroid compound naturally found in skin and other tissues. It serves as a precursor ingredient that helps stabilize the formulation and may support the product's intended chemical stability.
  • UNII L4EL31FWIL
    A synthetic peptide (short chain of amino acids) used as a conditioning or texture-enhancing agent in topical formulations. It helps improve product feel and skin compatibility in creams and lotions.
  • 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 BB4PU4V09H
    A plant-derived gum that acts as a thickener and stabilizer in medications. It helps maintain consistent texture and prevents ingredient separation in liquid or semi-solid formulations.
  • UNII JZ1374NL9E
    A synthetic polymer made from acrylic compounds that forms a flexible coating. It's used to coat tablets and capsules to control where and how the medicine dissolves in the digestive system, or to protect the ingredient from moisture and stomach acid.
  • 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 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 3G6A5W338E
    Caffeine is a natural stimulant compound commonly extracted from coffee beans and tea leaves. In medicines, it serves as an active booster in pain relievers and cold products to enhance alertness and improve the effectiveness of other ingredients.
  • 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 8D9H4QU99H
    A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
  • UNII 63ZP7I1BQO
    A plant-derived thickening agent made from xanthan gum that has been chemically modified. It helps give the medicine the right texture and consistency, and may act as a binder or stabilizer in tablets and liquids.
  • 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 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 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 S3KFG6Q5X8
    An organic chemical compound used as a UV filter in topical formulations. It helps protect the medicine or product from degradation caused by sunlight exposure during storage and use.
  • 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 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 YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII 113171Q70B
    Lauroyl lysine is a compound made by combining an amino acid (lysine) with a fatty acid (lauric acid). It works as a glidant and lubricant to help powder particles flow smoothly during manufacturing and tablet compression.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII HO4ZT5S86C
    A synthetic peptide derived from amino acids, used as a skin-conditioning agent and emollient in topical formulations to help soften and smooth the skin surface.
  • UNII Q41S464P1R
    A synthetic peptide (short protein-like molecule) used in skincare and cosmetic formulations as an active conditioning ingredient to help improve skin texture and appearance. It may function as a humectant or skin-conditioning agent in topical products.
  • 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 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 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 T9296U138P
    A synthetic polymer derived from polyester chemistry, modified with a cyanodiphenylpropenoyl cap. It serves as a film-former and binder in pharmaceutical formulations, helping create protective coatings on tablets or improving product consistency.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 253MC0P0YV
    A waxy compound made from glycerin and stearic acid, used as an emulsifier to help mix oil and water-based ingredients together in the formulation.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII K2P8K2558N
    A red marine microalga used as a natural colorant in medications and supplements. It provides red to purple coloring to tablets, capsules, and other formulations.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • 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 MAL0SND89Q
    A synthetic liquid made from petroleum-derived ingredients. It works as an emulsifier and solubilizer, helping mix oil and water-based components and keeping active ingredients dissolved in the medicine.
  • UNII ZM9Q0FEI4Z
    A plant extract from Sigesbeckia orientalis used in traditional herbal formulations. It may function as an active botanical ingredient or help deliver other components in the medicine.
  • 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 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 NG5NG5733T
    A synthetic polymer derived from acrylic acid and taurine. It functions as a suspending agent and emulsifier, helping keep ingredients evenly distributed and preventing separation in liquid or semi-solid medicines.
  • UNII VU97D01BF9
    A waxy emulsifier derived from sorbitol, a natural sugar alcohol. It helps blend oil and water-based ingredients together and improves the texture and stability of the medicine.
  • 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 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 8617Z5FMF6
    Whey is a milk-derived protein and carbohydrate byproduct. It functions as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the formulation.

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

The official label also stateswater\aqua\eau, glycerin, butylene glycol, coco-caprylate/caprate, polyester-8, ethylhexyl methoxycrylene, butyloctyl salicylate, acrylates copolymer, dextrin palmitate, peg-100 stearate, silica, polyglyceryl-2 stearate, whey protein\lactis protein\protéine du petit-lait, algae extract, saccharomyces ferment, caprylyl glycol, sigesbeckia orientalis (st. paul's wort) extract, caffeine, lauroyl lysine, sodium hyaluronate, biosaccharide gum-1, 7-dehydrocholesterol, plankton extract, acetyl hexapeptide-8, palmitoyl tripeptide-1, palmitoyl hexapeptide-12, palmitoyl tetrapeptide-7, peg-8, tocopheryl acetate, pentylene glycol, hexylene glycol, sodium polyacryloyldimethyl taurate, stearyl alcohol, dehydroxanthan gum, dipropylene glycol, carbomer, potassium hydroxide, glyceryl polymethacrylate, acrylates/beheneth-25 methacrylate copolymer, lecithin, polysorbate 20, sorbitan sesquiisostearate, ppg-8-ceteth-20, glyceryl stearate, sorbeth-30 tetraisostearate, acrylates/c10-30 alkyl acrylate crosspolymer, bht, sodium citrate, disodium edta, phenoxyethanol, sodium benzoate, potassium sorbate <iln51459>

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.

Manufacturer & labeler

LabelerCLINIQUE LABORATORIES LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code49527
First marketedMay 2023
Product typeHuman Otc Drug
Portfolio61 products on file

More NDCs from CLINIQUE LABORATORIES LLC labeler code 49527

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.

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 4 words ▾

Use helps prevent sunburn

⏱️ Dosage and Administration 94 words ▾

Direction 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% HOMOSALATE 7.0% OCTINOXATE 3.5% OCTISALATE 4.5%

🧪 Inactive Ingredients 105 words ▾

Inactive Ingredients water\aqua\eau, glycerin, butylene glycol, coco-caprylate/caprate, polyester-8, ethylhexyl methoxycrylene, butyloctyl salicylate, acrylates copolymer, dextrin palmitate, peg-100 stearate, silica, polyglyceryl-2 stearate, whey protein\lactis protein\protéine du petit-lait, algae extract, saccharomyces ferment, caprylyl glycol, sigesbeckia orientalis (st. paul's wort) extract, caffeine, lauroyl lysine, sodium hyaluronate, biosaccharide gum-1, 7-dehydrocholesterol, plankton extract, acetyl hexapeptide-8, palmitoyl tripeptide-1, palmitoyl hexapeptide-12, palmitoyl tetrapeptide-7, peg-8, tocopheryl acetate, pentylene glycol, hexylene glycol, sodium polyacryloyldimethyl taurate, stearyl alcohol, dehydroxanthan gum, dipropylene glycol, carbomer, potassium hydroxide, glyceryl polymethacrylate, acrylates/beheneth-25 methacrylate copolymer, lecithin, polysorbate 20, sorbitan sesquiisostearate, ppg-8-ceteth-20, glyceryl stearate, sorbeth-30 tetraisostearate, acrylates/c10-30 alkyl acrylate crosspolymer, bht, sodium citrate, disodium edta, phenoxyethanol, sodium benzoate, potassium sorbate <iln51459>

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin

📄 When Using This Product 13 words ▾

When using this product keep out of eyes. Rinse with water to remove.

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask a doctor if rash occurs

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 27 words ▾

Principal Display Panel CLINIQUE smart clinical repair broad spectrum SPF 30 wrinkle correcting cream CL1870 PEPTIDE COMPLEX POIDS NET WT.

1.7OZ./50 ml e Principal Display Panel

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 (this brand).

Top reported reactions

Drug Hypersensitivity1
Eye Irritation1
Suspected Counterfeit Product1

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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 1 jar (49527-0083-01), 1 jar (49527-0083-02), 1 jar (49527-0083-04). 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?
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.
← 49527-0082-01 · CLINIQUE 49527-0084-01 · 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.