CLARINS Super Restorative Day Illuminating lifting replenishing BROAD SPECTRUM - SPF 20 - Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE 30 mg/mL; 100 mg/mL; 27 mg/mL Cream — NDC 58668-0961-01 package photo

CLARINS Super Restorative Day Illuminating lifting replenishing BROAD SPECTRUM - SPF 20 - Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE 30 mg/mL; 100 mg/mL; 27 mg/mL Cream

by Laboratoires Clarins · 1 JAR in 1 CARTON (58668-0961-1) / 50 mL in 1 JAR
NDC 58668-0961-01
🏷️ FDA NDC (as labeled) 58668-0961-1 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 →

🆔 Identity & classification

FDA NDC (as labeled) 58668-0961-1
Product NDC 58668-0961
11-digit billing NDC 58668096101
UNII G63QQF2NOX, V06SV4M95S, 5A68WGF6WM
Application # M020
SPL Set ID c6dffe5c-5539-4e86-bf5e-b0e497eb9c88
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-07-29
Route TOPICAL
Dosage form CREAM
Substance AVOBENZONE; HOMOSALATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 58668-0961-1 — 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 → 58668-0961-01. 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 marketedJul 2013
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 topical cream designed to be applied to the skin and marketed as a broad-spectrum sunscreen with SPF 20. It contains three ultraviolet (UV) light-filtering ingredients: avobenzone, homosalate, and octocrylene. These chemicals are typically used together in sunscreen products to help absorb and scatter UV radiation from the sun. As an over-the-counter monograph product, it is regulated under FDA's established rules for sunscreen ingredients rather than through individual product approval.

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 A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII 2V52R0NHXW
    Ascorbyl glucoside is a stable form of vitamin C derived from ascorbic acid and glucose. It functions as an antioxidant in medicines to protect other ingredients from breaking down when exposed to air or light.
  • UNII 25BB7EKE2E
    Barium sulfate is a white powder mineral compound used as a filler and opacifying agent in tablets and capsules. It adds bulk to the medicine and may be included in formulations for imaging purposes.
  • 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 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 WL0328HX19
    A natural plant-based wax derived from candelilla shrub leaves. It acts as a coating agent, hardener, and texture modifier to control how quickly the medicine releases and to improve the tablet or capsule's appearance and stability.
  • 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 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 X3W0AM1JLX
    A synthetic red dye used to color medicines and products. It helps make pills, liquids, and capsules visually distinct and easier to identify.
  • 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 4763AXI84L
    Glyceryl monolinoleate is a fatty substance derived from linoleic acid, a natural oil component. It acts as an emulsifier and surfactant in medicines, helping blend oil and water-based ingredients together for better mixing and stability.
  • 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 V8A1AW0880
    Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
  • UNII 89NA02M4RX
    Pectin is a natural fiber extracted from fruit and plants. It's used in medicines as a thickener, binder, and gelling agent to create the right texture and help the product hold together.
  • 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 03KCY6P7UT
    A waxy compound derived from cetyl alcohol and phosphoric acid. It acts as an emulsifier to help blend oil and water ingredients, and as a thickener to give the medicine its proper texture and consistency.
  • 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 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII 3S5ITS5ULN
    Rhodiola rosea root is a plant extract used in some supplements and medicines. It functions as an active botanical ingredient intended to support wellness, though it's listed here as an excipient in this particular formulation.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • 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 3OSQ643ZK5
    Sucrose palmitate is a manufactured ingredient made by combining sugar with palmitic acid. It acts as an emulsifier and surfactant, helping oils and water mix together smoothly in liquid or semi-solid medicines.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII 775R692494
    A liquid extract from heat-loving bacteria that helps support the immune system's natural defenses. It acts as an active ingredient enhancer in topical formulations, helping the product work more effectively on skin.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII 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 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.

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

The official label also statesAQUA/WATER/EAU - GLYCERIN - BUTYLOCTYL SALICYLATE - C12-15 ALKYL BENZOATE - ALCOHOL - DIMETHICONE - CETEARYL ALCOHOL - OLUS OIL/VEGETABLE OIL/HUILE VEGETALE - PENTYLENE GLYCOL - BUTYROSPERMUM PARKII (SHEA) BUTTER - POTASSIUM CETYL PHOSPHATE - TROMETHAMINE - CETEARYL GLUCOSIDE - PARFUM/FRAGRANCE - ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER - ASCORBYL GLUCOSIDE - SUCROSE PALMITATE - TOCOPHERYL ACETATE - HYDROGENATED VEGETABLE OIL - ETHYLHEXYLGLYCERIN - XANTHAN GUM - BUTYLENE GLYCOL - GLYCERYL LINOLEATE - SODIUM HYALURONATE - DISODIUM EDTA - CANDELILLA CERA/EUPHORBIA CERIFERA (CANDELILLA) WAX/CIRE DE CANDELILLA - TOCOPHEROL - MICA - CI 77120/BARIUM SULFATE - CI 77891/TITANIUM DIOXIDE - HARUNGANA MADAGASCARIENSIS EXTRACT - CITRIC ACID - POTASSIUM SORBATE - PROPANEDIOL - OLEA EUROPAEA (OLIVE) FRUIT EXTRACT - PECTIN - THERMUS THERMOPHILUS FERMENT - HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL - GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE - PHENOXYETHANOL - LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT - CAMELLIA SINENSIS LEAF EXTRACT - RHODIOLA ROSEA ROOT EXTRACT - CI 14700/RED 4 - SODIUM LAURYL SULFATE - ACETYL TETRAPEPTIDE-2 - DEXTRAN. [S2628A]

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 DailyMedingredient 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
CLARINS Super Restorative Day Illuminating lifting replenishing BROAD SPECTRUM - SPF 20 - Sunscreen 30 mg/mL; 100 mg/mL; 27 mg/mLthis 58668-0961-01 Laboratoires 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

🏛️
2013
On the market since
Jul 2013
📍
2026
Currently FDA-listed
13 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
58668-0961-01 You're viewing this 1 JAR in 1 CARTON (58668-0961-1) / 50 mL in 1 JAR 2013-07-29 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 58668-0961-1, 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: 58668-0961-01, written without dashes as 58668096101. 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 58668-0961-01, the first segment (58668) is the labeler code FDA assigned to Laboratoires Clarins; the middle segment (0961) 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 29 words

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

⏱️ Dosage and Administration 97 words

Directions: apply liberally 15 minutes before sun exposure apply to all skin exposed to the sun children under 6 month: Ask a doctor Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures. 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 8 words

Active ingredients AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 2.7%

🧪 Inactive Ingredients 163 words

Inactive ingredients: AQUA/WATER/EAU - GLYCERIN - BUTYLOCTYL SALICYLATE - C12-15 ALKYL BENZOATE - ALCOHOL - DIMETHICONE - CETEARYL ALCOHOL - OLUS OIL/VEGETABLE OIL/HUILE VEGETALE - PENTYLENE GLYCOL - BUTYROSPERMUM PARKII (SHEA) BUTTER - POTASSIUM CETYL PHOSPHATE - TROMETHAMINE - CETEARYL GLUCOSIDE - PARFUM/FRAGRANCE - ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER - ASCORBYL GLUCOSIDE - SUCROSE PALMITATE - TOCOPHERYL ACETATE - HYDROGENATED VEGETABLE OIL - ETHYLHEXYLGLYCERIN - XANTHAN GUM - BUTYLENE GLYCOL - GLYCERYL LINOLEATE - SODIUM HYALURONATE - DISODIUM EDTA - CANDELILLA CERA/EUPHORBIA CERIFERA (CANDELILLA) WAX/CIRE DE CANDELILLA - TOCOPHEROL - MICA - CI 77120/BARIUM SULFATE - CI 77891/TITANIUM DIOXIDE - HARUNGANA MADAGASCARIENSIS EXTRACT - CITRIC ACID - POTASSIUM SORBATE - PROPANEDIOL - OLEA EUROPAEA (OLIVE) FRUIT EXTRACT - PECTIN - THERMUS THERMOPHILUS FERMENT - HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL - GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE - PHENOXYETHANOL - LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT - CAMELLIA SINENSIS LEAF EXTRACT - RHODIOLA ROSEA ROOT EXTRACT - CI 14700/RED 4 - SODIUM LAURYL SULFATE - ACETYL TETRAPEPTIDE-2 - DEXTRAN. [S2628A]

🎯 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 ↗
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.