Home › NDC Lookup › 58668-1619-01
Clarins UV PLUS ANTI-POLLUTION B.S. SPF 50, Sunscreen Multi-Protection Tint Medium HOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDE 40 mg/mL; 40 mg/mL; 15 mg/mL; 84 mg/mL Liquid — NDC 58668-1619-01 package photo

Clarins UV PLUS ANTI-POLLUTION B.S. SPF 50, Sunscreen Multi-Protection Tint Medium HOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDE 40 mg/mL; 40 mg/mL; 15 mg/mL; 84 mg/mL Liquid

by Laboratoires Clarins · 1 BOTTLE in 1 CARTON (58668-1619-1) / 50 mL in 1 BOTTLE
NDC 58668-1619-01
🏷️ FDA NDC (as labeled) 58668-1619-1 billing pads the package 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) 58668-1619-1
Product NDC 58668-1619
11-digit billing NDC 58668161901
UNII V06SV4M95S, 5A68WGF6WM, 95OOS7VE0Y, 15FIX9V2JP
Application # M020
SPL Set ID 2c0964cd-607c-4219-b66e-cc99ada80434
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-09-22
Route TOPICAL
Dosage form LIQUID
Substance HOMOSALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 58668-1619-1 — 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 → 58668-1619-01. 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

LabelerLaboratoires Clarins
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code58668
First marketedSep 2015
Product typeHuman Otc Drug
Portfolio14 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 a tinted liquid sunscreen lotion applied to the skin that contains four active ingredients working together to block ultraviolet (UV) radiation. Homosalate, octocrylene, and oxybenzone are organic UV filters that absorb sun rays, while titanium dioxide is a mineral UV filter that reflects and scatters them. This combination is typically used in over-the-counter sunscreen products to help protect skin from UV exposure when applied topically.

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 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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 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 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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • 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 W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability 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 T9B77O7PZA
    A plant extract from common nipplewort flowering tops, used as a natural ingredient to add botanical content to the formulation. It may serve as a flavoring agent or contribute to the product's composition.
  • UNII K3Z4F929H6
    Lysine is an amino acid that serves as a buffer and pH regulator in medications. It helps maintain the medicine's stability and proper acidity level during storage and use.
  • UNII 02F3473H9O
    A mineral salt used in medications as a source of magnesium. It helps bind ingredients together, improve texture, and maintain the product's stability during storage.
  • UNII ZV095H5633
    A natural flavoring derived from muskmelon fruit. It is used in medicines to add pleasant taste and aroma, making the product more acceptable to take.
  • UNII 446U8J075B
    Nylon-12 is a synthetic plastic polymer used as a coating or film-forming agent in medicines. It helps create a protective barrier around tablets or capsules to control how and when the medicine is released in the body.
  • UNII ZEL54N6W95
    A silicone-based compound that helps oils and water mix together. Used in medicines as an emulsifier and anti-foaming agent to improve texture and prevent bubbles in liquids and creams.
  • UNII 9H0AO7T794
    A silicone-based lubricant mixed with polyethylene glycol and polypropylene glycol polymers. It reduces friction between pill surfaces and equipment during manufacturing, and helps the finished product slide smoothly when swallowed.
  • 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 VYH9Y9BCCP
    A natural plant extract from black currant flower buds. Used as a flavor and coloring agent to improve the taste and appearance of the medicine.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII NCX1UU2D33
    Sodium lauroyl glutamate is a mild cleanser derived from coconut oil and the amino acid glutamate. In medicines, it acts as a surfactant and emulsifier to help mix oily and watery ingredients and improve how the product spreads or dissolves.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • 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.

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

The official label also statesDIMETHICONE. AQUA/WATER/. CI 77891/TITANIUM DIOXIDE. ALCOHOL. POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE. ALUMINUM HYDROXIDE. STEARIC ACID. CI 77492/IRON OXIDES. PEG/PPG-18/18 DIMETHICONE. NYLON-12. PEG-12 DIMETHICONE. SODIUM CHLORIDE. PHENOXYETHANOL. PARFUM/FRAGRANCE. CI 77491/IRON OXIDES. GLYCERIN. ETHYLHEXYLGLYCERIN. TOCOPHERYL ACETATE. CI 77499/IRON OXIDES. DISODIUM EDTA. SANICULA EUROPAEA EXTRACT. BUTYLENE GLYCOL. SODIUM LAUROYL GLUTAMATE. LYSINE. MAGNESIUM CHLORIDE. SODIUM HYALURONATE. HYDROXYPROPYLTRIMONIUM MALTODEXTRIN CROSSPOLYMER. THERMUS THERMOPHILLUS FERMENT. RIBES NIGRUM (BLACK CURRANT) BUD EXTRACT. POTASSIUM SORBATE. CITRIC ACID. CAMELLIA SINENSIS LEAF EXTRACT. CUCUMIS MELO (MELON) FRUIT EXTRACT. LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT. SODIUM LAURYL SULFATE. [S2703A]

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 mLPer 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
Clarins UV PLUS ANTI-POLLUTION B.S. SPF 50, Sunscreen Multi-Protection Tint Medium 40 mg/mL; 40 mg/mL; 15 mg/mL; 84 mg/mLthis 58668-1619-01 Laboratoires 1 bottle — — 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

🏛️
2015
On the market since
Sep 2015
📍
2026
Currently FDA-listed
11 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
58668-1619-01 You're viewing this 1 BOTTLE in 1 CARTON (58668-1619-1) / 50 mL in 1 BOTTLE 2015-09-22 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 ✓ 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 FDA registers it as 58668-1619-1, 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: 58668-1619-01, written without dashes as 58668161901. 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 58668-1619-01, the first segment (58668) is the labeler code FDA assigned to Laboratoires Clarins; the middle segment (1619) 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 Laboratoires Clarins. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Laboratoires Clarins is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 33 words ▾

Uses: • helps prevent sunburn • if used as directed with other sun protection measures ( see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

⏱️ Dosage and Administration 105 words ▾

Directions: • apply liberally 15 minutes before sun exposure • apply to all skin exposed to the sun • children under 6 months: Ask a doctor • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF 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 • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating

⚠️ 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.

🧪 Active Ingredient 13 words ▾

Active ingredients HOMOSALATE 4% OCTOCRYLENE 4% OXYBENZONE 1.5% TITANIUM DIOXIDE 8.4% Purpose Sunscreen

🧪 Inactive Ingredients 85 words ▾

Inactive ingredients: DIMETHICONE. AQUA/WATER/. CI 77891/TITANIUM DIOXIDE.

ALCOHOL. POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE. ALUMINUM HYDROXIDE.

STEARIC ACID. CI 77492/IRON OXIDES. PEG/PPG-18/18 DIMETHICONE.

NYLON-12. PEG-12 DIMETHICONE. SODIUM CHLORIDE.

PHENOXYETHANOL. PARFUM/FRAGRANCE. CI 77491/IRON OXIDES.

GLYCERIN. ETHYLHEXYLGLYCERIN. TOCOPHERYL ACETATE.

CI 77499/IRON OXIDES. DISODIUM EDTA. SANICULA EUROPAEA EXTRACT.

BUTYLENE GLYCOL. SODIUM LAUROYL GLUTAMATE. LYSINE.

MAGNESIUM CHLORIDE. SODIUM HYALURONATE. HYDROXYPROPYLTRIMONIUM MALTODEXTRIN CROSSPOLYMER.

THERMUS THERMOPHILLUS FERMENT. RIBES NIGRUM (BLACK CURRANT) BUD EXTRACT. POTASSIUM SORBATE.

CITRIC ACID. CAMELLIA SINENSIS LEAF EXTRACT. CUCUMIS MELO (MELON) FRUIT EXTRACT.

LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT. SODIUM LAURYL SULFATE. [S2703A]

🎯 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 ↗
← 58668-1618-01 · Laboratoires 58668-1621-01 · Laboratoires →
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.