cle de peau BEAUTE PROTECTIVE FORTIFYING n AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE 1.031 g/50mL; 2.52595 g/50mL; 2.5775 g/50mL; 1.031 g/50mL Cream, 50 mL
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Cle de Peau Beaute Protective Fortifying is a topical cream containing four UV-filtering agents: avobenzone, octinoxate, octocrylene, and oxybenzone. These ingredients are commonly used together in sunscreen products to help absorb ultraviolet radiation from the sun. This is an over-the-counter monograph product, meaning it is marketed under FDA's established rules for sunscreen ingredients rather than as an individually reviewed new drug application.
Patient education
Supplement & herbal interactions
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🧪 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.
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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.
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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.
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UNII 3W51R3EK30
A plant extract from angelica root used in traditional Asian medicine preparations. It may serve as a flavoring agent, fragrance component, or natural additive in herbal formulations.
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UNII CUQ3A77YXI
Panax ginseng root is a plant extract traditionally used in herbal preparations. In medications, it may serve as an active botanical ingredient or be included for flavoring and as a natural preservative or binder in formulations.
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UNII BJ4GP2IFLN
Beheneth-20 is a surfactant derived from behenic acid, a fatty acid. It helps mix oil and water-based ingredients together in formulations and can act as an emulsifier or solubilizer.
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UNII 8SKN0B0MIM
Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
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UNII X04E310LUY
Bupleurum falcatum root is a plant extract used as a natural flavoring and botanical ingredient. It may help mask bitter tastes and add herbal characteristics to the medicine.
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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.
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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.
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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.
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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.
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UNII NT52AMP29J
A plant extract from hawthorn flowers used as a natural flavoring agent and coloring ingredient in medicines. It may also help bind ingredients together in tablet or capsule formulations.
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UNII 0THT5PCI0R
A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
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UNII 69W9UMG3P8
A synthetic oily compound used as a plasticizer and solvent in medicines. It helps soften and improve flexibility of coatings on tablets and capsules, and aids in dissolving or dispersing active ingredients in liquid formulations.
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UNII J8T3X564IH
A clear oily liquid derived from sebacic acid, used as a plasticizer and solvent in pharmaceutical coatings and films to improve flexibility and help active ingredients dissolve properly.
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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.
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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.
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UNII 6D5V13045W
A plant extract from European beech flower buds used in some herbal or botanical formulations. It may serve as an active botanical ingredient or flavoring agent depending on the product's intended use.
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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.
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UNII 19FUJ2C58T
Ginkgo biloba leaf is a plant extract used as a flavoring or coloring agent in some medicines. It may also serve as a natural ingredient to support the product's formulation.
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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.
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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.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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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.
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UNII FD2FMC53M1
A plant extract from the spiny restharrow root, traditionally used in herbal preparations. In medicines, it functions as a natural flavoring agent or botanical additive to support formulation characteristics.
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UNII 3Z3866YW6P
A plant extract from peony root used in traditional herbal formulations. It may function as a flavoring agent, natural colorant, or botanical ingredient to support the product's herbal composition.
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UNII 6DNW9T7YT2
A synthetic liquid polymer made from ethylene and propylene compounds. It acts as a solvent and humectant to help dissolve active ingredients and maintain moisture in the formulation.
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UNII 4ET18WJG5K
A synthetic liquid polymer made from ethylene glycol and propylene glycol components. Used in medications as a solvent to dissolve active ingredients and improve how the medicine flows and mixes in liquid formulations.
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UNII T4L5881Y68
A plant-derived ingredient from perilla leaves, used as a natural flavoring agent and to provide potential sensory or aromatic qualities to the medicine.
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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.
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UNII 233VSF903M
A plant-derived oil compound used as an emollient and skin-conditioning agent. It helps soften the product texture and improve how the medicine spreads on or absorbs into the skin.
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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.
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UNII OV0Q322E0U
PPG-17 is a synthetic liquid polymer made from propylene glycol. It acts as a humectant and solvent in medicines, helping to dissolve active ingredients and maintain moisture in the product.
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UNII 3TNW8D08V3
Rosa canina fruit, also called rosehip, is a natural plant extract used in medicines as a filler and to add nutritional content. It may also help with texture or act as a mild flavoring agent in the formulation.
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UNII CVT1AA87FF
A plant extract from Rosa roxburghii fruit (also called chestnut rose), used as a natural flavoring agent, colorant, or antioxidant in medicines to improve taste and help preserve the product.
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UNII WN66R7GL93
A modified form of hyaluronic acid, a naturally occurring substance that holds water. Used as a thickener, lubricant, and moisture-retaining agent in formulations, especially in topical or injectable products.
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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.
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UNII 532IUT7IRV
A salt derived from phosphoric acid, sodium metaphosphate acts as a buffer and sequestrant in medicines. It helps stabilize the product and prevent unwanted chemical reactions during storage.
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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.
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UNII 8021PR16QO
Theanine is an amino acid found naturally in tea leaves. In medications, it's typically used as an active ingredient for its potential calming effects, though it may also function as a flavor component or dietary supplement ingredient in some formulations.
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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.
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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.
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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.
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UNII 9O3K93S3TK
Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
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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.
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UNII 728JDI7G4M
A natural extract from the fruit rind of the Sichuan pepper plant. It serves as a flavoring agent to improve taste and may provide aroma to the medicine.
46 inactive ingredients listed in the exact product block matched to this NDC.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 system | Per g | Per 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. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| cle de peau BEAUTE PROTECTIVE FORTIFYING n 1.031 g/50mL; 2.52595 g/50mL; 2.5775 g/50mL; 1.031 g/50mLthis 58411-0857-40 | SHISEIDO | 50 ml | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 58411-0857-40 You're viewing this | 1 CONTAINER in 1 CARTON (58411-857-40) / 50 mL in 1 CONTAINER | 2022-07-01 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Is this NDC FDA-approved?
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
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 ▾
Directions For sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours 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 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-sleeve shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor
⚠️ Warnings ▾
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 ▾
Other information protect this product in this container from excessive heat and direct sun.
🧪 Active Ingredient ▾
Active ingredients Purpose AVOBENZONE 2.0% Sunscreen OCTINOXATE 4.9% Sunscreen OCTOCRYLENE 5.0% Sunscreen OXYBENZONE 2.0% Sunscreen
🧪 Inactive Ingredients ▾
Inactive ingredients WATER ▪ CYCLOPENTASILOXANE ▪ GLYCERIN ▪ DIISOPROPYL SEBACATE ▪ BUTYLENE GLYCOL ▪ DIETHYLHEXYL SUCCINATE ▪ SD ALCOHOL 40-B ▪ TREHALOSE ▪ PEG/PPG-14/7 DIMETHYL ETHER ▪ DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER ▪ TOCOPHERYL ACETATE ▪ PEG/PPG-17/4 DIMETHYL ETHER ▪ PHYTOSTERYL MACADAMIATE ▪ POLYQUATERNIUM-51 ▪ GINKGO BILOBA LEAF EXTRACT ▪ ANGELICA ACUTILOBA ROOT EXTRACT ▪ PAEONIA ALBIFLORA ROOT EXTRACT ▪ CRATAEGUS MONOGYNA FLOWER EXTRACT ▪ PANAX GINSENG ROOT EXTRACT ▪ GLYCINE ▪ ONONIS SPINOSA ROOT EXTRACT ▪ HYDROLYZED SILK ▪ ROSA CANINA FRUIT EXTRACT ▪ ZANTHOXYLUM PIPERITUM PEEL EXTRACT ▪ HIBISCUS ESCULENTUS FRUIT EXTRACT ▪ FAGUS SYLVATICA BUD EXTRACT ▪ SODIUM ACETYLATED HYALURONATE ▪ PERILLA OCYMOIDES LEAF EXTRACT ▪ ROSA ROXBURGHII FRUIT EXTRACT ▪ HYDROLYZED CONCHIOLIN PROTEIN ▪ ISODONIS JAPONICUS LEAF/STALK EXTRACT ▪ BUPLEURUM FALCATUM ROOT EXTRACT ▪ BEHENETH-20 ▪ PPG-17 ▪ BEHENYL ALCOHOL ▪ CARBOMER ▪ POLYSORBATE 20 ▪ TRIETHANOLAMINE ▪ DISODIUM EDTA ▪ STEARYL ALCOHOL ▪ HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER ▪ THEANINE ▪ SODIUM CITRATE ▪ ALCOHOL ▪ SODIUM METAPHOSPHATE ▪ CITRIC ACID ▪ BHT ▪ TOCOPHEROL ▪ PHENOXYETHANOL ▪ METHYLPARABEN ▪ BENZOIC ACID ▪ FRAGRANCE ▪ MICA ▪ TITANIUM DIOXIDE ▪ IRON OXIDES ▪
🎯 Purpose ▾
Active ingredients Purpose AVOBENZONE 2.0% Sunscreen OCTINOXATE 4.9% Sunscreen OCTOCRYLENE 5.0% Sunscreen OXYBENZONE 2.0% Sunscreen