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REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/O Octinoxate, Titanium Dioxide 75 mg/mL; 15 mg/mL Cream — NDC 49527-0118-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/O Octinoxate, Titanium Dioxide 75 mg/mL; 15 mg/mL Cream — NDC 49527-118-01 (Billing 49527-0118-01)

by CLINIQUE LABORATORIES LLC · 1 JAR in 1 CARTON / 50 mL in 1 JAR

This is a package of REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/O Octinoxate, Titanium Dioxide 75 mg/mL; 15 mg/mL Cream from CLINIQUE LABORATORIES LLC, marketed since Feb 2024 and currently FDA-listed. It is this product's only package size.

NDC 49527-0118-01
🏷️ FDA NDC (as labeled) 49527-118-01 billing pads the product segment with a zero
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49527-118-01
Product NDC 49527-118
11-digit billing NDC 49527011801
UNII 4Y5P7MUD51, 15FIX9V2JP
Application # M020
SPL Set ID 10f7ec01-541b-a15a-e063-6294a90aa9df
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-02-09
Route TOPICAL
Dosage form CREAM
Substance OCTINOXATE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 49527-118-01 — 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 → 49527-0118-01. 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.

Clinical

🧪 What is this product?

Repairwear Laser Focus SPF 15 Line Smoothing is a topical cream marketed as an over-the-counter monograph sunscreen product. It contains two active ingredients: octinoxate and titanium dioxide, which are UV filters that work to protect skin from ultraviolet radiation. The product is intended to be applied to the skin to help prevent sun damage. This is an OTC monograph drug, meaning it follows FDA's established safety and effectiveness standards for sunscreen products 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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
49527-0118-01 You're viewing this Main listing 1 JAR in 1 CARTON / 50 mL in 1 JAR 2024-02-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Repairwear Laser Focus Spf 15 Line Smoothing Co/O 75 mg/mL; 15 mg/mLthis 49527-0118-01 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

🏛️
2024
On the market since
Feb 2024
📍
2026
Currently FDA-listed
2 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 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 415SHH325A
    A naturally occurring compound involved in cellular energy metabolism. In medicines, it may be used as a buffer to help maintain pH stability or as a component supporting formulation integrity.
  • UNII 5QB0T2IUN0
    Aluminum hydroxide is a white powder mineral compound used as an antacid ingredient in some formulations. It works as a buffer and pH regulator to help neutralize stomach acid in the medicine.
  • UNII 290O2PQ83R
    A stabilized form of vitamin C used in topical products as an antioxidant ingredient. It helps prevent degradation of other active ingredients and maintains product stability during storage.
  • UNII 12V64UPU6R
    A plant-based fat extracted from murumuru palm seeds. It acts as an emollient and thickener in topical formulations, helping create smooth texture and improve skin feel in creams and lotions.
  • UNII 3R504894L9
    A natural extract from birch tree bark used as a binder and thickening agent. It helps hold tablet ingredients together and may improve the product's texture and consistency.
  • UNII 2M6QWV94OC
    Black olive is a plant-derived ingredient used as a natural colorant to give medicines their dark appearance. It may also serve as a flavoring agent in some 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 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 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 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 134647WMX4
    Cetyl ethylhexanoate is a synthetic oil used as an emollient and texture enhancer in medications. It helps soften the skin, improve spreadability, and provides a smooth feel to topical formulations.
  • 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 V5741391RG
    A plant extract from Plectranthus barbatus root used in formulations as a natural flavoring agent and to support product stability. It may also function as a preservative or antioxidant in certain formulations.
  • UNII MU72812GK0
    Creatine is an organic compound that helps supply energy to muscle cells. In medicines, it may be used as a nutritional supplement ingredient or to support muscle function and performance.
  • UNII 6X7K9I5QR7
    A dipeptide compound derived from carnosine, used as an antioxidant and stabilizing agent in formulations to help protect the product and maintain ingredient stability during storage.
  • UNII E6AHA53N1H
    A synthetic amino acid derivative used as a skin-conditioning agent and emollient in topical formulations. It helps soften and smooth the product's texture while improving how it spreads on skin.
  • UNII 8295030YNC
    A coenzyme naturally found in cells that helps transfer energy during metabolism. In medicines, it serves as an active pharmaceutical ingredient or stabilizing agent to support formulation stability and performance.
  • UNII 9G1OE216XY
    Docosanol is a waxy, fatty alcohol derived from plant sources. It acts as an emollient and thickener in topical medicines, helping to soften the skin and improve product texture and stability.
  • 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 2865993309
    Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
  • UNII EG3PA2K3K5
    Ethylhexyl stearate is a waxy oil made from stearic acid and ethylhexyl alcohol. In medicines, it acts as an emollient and thickener to improve texture and help the product spread smoothly on skin or dissolve properly.
  • 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 TE7660XO1C
    Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
  • 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 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 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 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 9KJL21T0QJ
    Linoleic acid is an omega-6 fatty acid derived from plant oils. It serves as an emulsifier and skin conditioning agent in topical formulations, helping ingredients mix smoothly and improving product texture.
  • UNII 6777U11MKT
    A silicone-based lubricant and anti-foaming agent used to reduce surface tension and prevent foam formation during manufacturing and storage of the medication.
  • UNII X8725R883T
    A synthetic oily liquid derived from branched carboxylic acids, used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product's texture while improving how it spreads on skin.
  • UNII 177U06NHZI
    A seaweed extract derived from the brown algae Padina pavonica. It's used as a moisturizing and skin-conditioning agent in topical formulations to help soften and hydrate the skin.
  • 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 GIN46U9Q2Q
    Phytosphingosine is a naturally derived fatty compound that helps stabilize and thicken skincare and cosmetic formulations. It works as an emollient and conditioning agent to improve texture and skin feel in topical products.
  • UNII 7TRV45YZF7
    A plant extract from Japanese knotweed root used as a natural ingredient. It functions as an antioxidant and preservative to help maintain product stability and shelf life.
  • 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 1K573LC5TV
    A mineral salt used in medications as an electrolyte source and to adjust the osmotic balance of liquid formulations, helping the medicine absorb properly in the body.
  • UNII 9DLQ4CIU6V
    Proline is an amino acid used in pharmaceutical formulations as a bulking agent and stabilizer. It helps maintain product stability and can improve the texture or consistency of medicines, particularly in powders and freeze-dried products.
  • 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 V5032728L7
    A natural ingredient derived from robusta coffee beans, used primarily as a flavoring agent to add coffee taste and aroma to the medicine.
  • UNII R85W246Z1C
    A yeast-derived substance made from broken-down Saccharomyces cerevisiae cells. It is used as a natural humectant and moisturizing agent to help keep medicines and supplements stable and prevent them from drying out.
  • UNII 6UL878YAR7
    A plant extract from Sigesbeckia orientalis, a flowering herb used in traditional medicine. In medications, it may serve as an active botanical ingredient or natural additive for texture and formulation stability.
  • 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 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII L7HT8F1ZOD
    A plant-based oil extracted from soybeans. It's used as an emulsifier and lubricant to help mix ingredients evenly and prevent sticking during tablet or capsule manufacturing.
  • UNII JU3D414057
    A natural plant extract from tangerine fruit peel used as a flavoring agent and color contributor. It adds tangerine taste and may provide a slight orange tint to medicines.
  • UNII B8WCK70T7I
    Trehalose is a natural sugar made from two glucose molecules linked together. It's used in medicines as a filler to add bulk, a sweetener for taste, and a stabilizer to help keep active ingredients effective 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 6L966A1IMR
    Wheat bran is the fibrous outer layer of wheat grain. It acts as a filler and disintegrant in tablets and capsules, helping the medicine break apart and release its active ingredients in your body.
  • 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.

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

The official label also stateswater\aqua\eau,cetyl ethylhexanoate,butylene glycol,octyldodecyl neopentanoate,peg-100 stearate,glyceryl stearate,glycerin,hydrogenated lecithin,polyethylene,pentylene glycol,silica,citrus reticulata (tangerine) peel extract,saccharomyces lysate extract,polygonum cuspidatum root extract,algae extract,triticum vulgare (wheat) bran extract,coffea robusta seed extract,astrocaryum murumuru seed butter,padina pavonica thallus extract,betula alba (birch) bark extract,creatine,adenosine phosphate,laurdimonium hydroxypropyl hydrolyzed soy protein,linoleic acid,hydrolyzed rice extract,hydroxyproline,olea europaea (olive) fruit extract,sigesbeckia orientalis (st. paul's wort) extract,coleus barbatus extract,acetyl hexapeptide-8,sodium dna,caffeine,cholesterol,ethylhexyl stearate,sorbitol,ethylhexyl palmitate,decarboxy carnosine hcl,phytosphingosine,propylene glycol dicaprate,disodium nadh,caprylyl glycol,acrylates copolymer,trehalose,sodium rna,cetyl alcohol,dipalmitoyl hydroxyproline,proline,aminopropyl ascorbyl phosphate,behenyl alcohol,methicone,hexylene glycol,xanthan gum,sodium hyaluronate,potassium hydroxide,potassium sulfate,glycine,potassium sorbate,aluminum hydroxide,lecithin,carbomer,disodium edta,phenoxyethanol <iln41741>

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 marketedFeb 2024
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.

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 ▾

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 52 words ▾

Warnings 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 7 words ▾

Active Ingredients Octinoxate 7.5% Titanium Dioxide 1.5%

🧪 Inactive Ingredients 82 words ▾

Inactive Ingredients water\aqua\eau,cetyl ethylhexanoate,butylene glycol,octyldodecyl neopentanoate,peg-100 stearate,glyceryl stearate,glycerin,hydrogenated lecithin,polyethylene,pentylene glycol,silica,citrus reticulata (tangerine) peel extract,saccharomyces lysate extract,polygonum cuspidatum root extract,algae extract,triticum vulgare (wheat) bran extract,coffea robusta seed extract,astrocaryum murumuru seed butter,padina pavonica thallus extract,betula alba (birch) bark extract,creatine,adenosine phosphate,laurdimonium hydroxypropyl hydrolyzed soy protein,linoleic acid,hydrolyzed rice extract,hydroxyproline,olea europaea (olive) fruit extract,sigesbeckia orientalis (st. paul's wort) extract,coleus barbatus extract,acetyl hexapeptide-8,sodium dna,caffeine,cholesterol,ethylhexyl stearate,sorbitol,ethylhexyl palmitate,decarboxy carnosine hcl,phytosphingosine,propylene glycol dicaprate,disodium nadh,caprylyl glycol,acrylates copolymer,trehalose,sodium rna,cetyl alcohol,dipalmitoyl hydroxyproline,proline,aminopropyl ascorbyl phosphate,behenyl alcohol,methicone,hexylene glycol,xanthan gum,sodium hyaluronate,potassium hydroxide,potassium sulfate,glycine,potassium sorbate,aluminum hydroxide,lecithin,carbomer,disodium edta,phenoxyethanol <iln41741>

🎯 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 25 words ▾

CLINIQUE repairwear laser focus line smoothing cream braod spectrum SPF 15 COMBINATION OILY TO OILY POIDS NET WT.

1.7 OZ/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 Octinoxate, Titanium Dioxide — the ingredient across all brands.

Top reported reactions

Dermatitis Contact1
Emotional Distress1
Hyperaesthesia1
Hypersensitivity1
Product Formulation Issue1
Rash1
Self Esteem Decreased1

Reporter sex

2 reports
Female · 100%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2 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.

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.
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.
← 49527-0117-01 · CLINIQUE 49527-0119-01 · 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.