CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n avobenzone, octinoxate, octocrylene, and oxybenzone 3200 mg/125mL; 9472 mg/125mL; 2560 mg/125mL; 1280 mg/125mL Emulsion, 125 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 emulsion (lotion) marketed as an over-the-counter sunscreen under FDA's monograph rules for that product category. It contains four chemical UV filters: avobenzone, octinoxate, octocrylene, and oxybenzone, which are typically used to absorb ultraviolet radiation from the sun. These ingredients work together in sunscreen products to help protect the skin from UVA and UVB exposure when applied to the skin.
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 H4N855PNZ1
Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
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UNII WR1WPI7EW8
A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
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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 39YR661C4U
A synthetic chemical compound used as a preservative in medicines to prevent bacterial and fungal growth, helping keep the product safe and effective during storage.
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UNII H390488X0A
Behenic acid is a waxy substance derived from plant oils. It functions as a lubricant and binder in tablets and capsules, helping reduce friction during manufacturing and holding ingredients together.
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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 K679OBS311
Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
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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 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.
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UNII I445L28B12
A silicone-based compound that acts as a lubricant and glidant in tablet and capsule formulations. It reduces friction between particles and on equipment surfaces, helping medicines flow smoothly during manufacturing and tablet compression.
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UNII E107L85C40
Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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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 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.
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UNII 14255EXE39
Ethylparaben is a preservative, a chemical that stops bacteria and mold from growing in the medicine. It keeps the product safe and effective throughout its shelf life.
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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 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.
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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.
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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 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.
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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 U333RI6EB7
Hydrogenated polydecene type I is a synthetic oil derived from plant-based polymers. It acts as a lubricant and glidant to help powder ingredients flow smoothly during tablet or capsule manufacturing.
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UNII A8289P68Y2
Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
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UNII X33R8U0062
Isostearic acid is a fatty acid derived from vegetable oils. It acts as an emulsifier and lubricant in medicines, helping blend ingredients together and reducing friction during tablet or capsule manufacturing.
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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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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 8CAC4NQ872
A synthetic emulsifier made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and improves the product's texture and stability in creams, lotions, and other formulations.
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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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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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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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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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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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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.
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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 P1BM4ZH95L
A salt derived from phosphoric acid, sodium polymetaphosphate acts as a sequestrant and buffering agent in medicines. It helps maintain stability and control acidity in liquid formulations.
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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.
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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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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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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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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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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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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.
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UNII VCQ006KQ1E
Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.
52 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 mL | 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 3200 mg/125mL; 9472 mg/125mL; 2560 mg/125mL; 1280 mg/125mLthis 58411-0454-10 | SHISEIDO | 125 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 |
|---|---|---|---|
| 58411-0454-10 You're viewing this | 1 CONTAINER in 1 CARTON (58411-454-10) / 125 mL in 1 CONTAINER | 2019-02-01 | 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 | ✓ 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. |
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 2.5% Sunscreen OCTINOXATE 7.4% Sunscreen OCTOCRYLENE 2.0% Sunscreen OXYBENZONE 1.0% Sunscreen
🧪 Inactive Ingredients ▾
Inactive Ingredients WATER ∙ DIPROPYLENE GLYCOL ∙ SD ALCOHOL 40-B ∙ GLYCERIN ∙ HYDROGENATED POLYDECENE ∙ XYLITOL・DIMETHICONE ∙ ISODODECANE ∙ PEG/PPG-14/7 DIMETHYL ETHER ∙ PEG-5 GLYCERYL STEARATE ∙ SILICA ∙ ISOSTEARIC ACID ∙ DIPHENYLSILOXY PHENYL TRIMETHICONE ∙ XANTHAN GUM ∙ TREHALOSE ∙ TOCOPHERYL ACETATE ∙ PEG/PPG ∙ 17/4 DIMETHYL ETHER ∙ PHYTOSTERYL MACADAMIATE ∙ 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 ∙ PPG-17 ∙ TRIETHANOLAMINE ∙ GLYCERYL STEARATE SE ∙ BEHENYL ALCOHOL ∙ BEHENIC ACID ∙ STEARIC ACID ∙ BUTYLENE GLYCOL ∙ BATYL ALCOHOL ∙ THEANINE ∙ PEG-30 PHYTOSTEROL ∙ CARBOMER ∙ DISODIUM EDTA・ALCOHOL ∙ CELLULOSE GUM ∙ SODIUM METAPHOSPHATE ∙ BHT ∙ TOCOPHEROL ∙ METHYLPARABEN ∙ ETHYLPARABEN ∙ PHENOXYETHANOL ∙ BENZOIC ACID ∙ FRAGRANCE ∙ TITANIUM DIOXIDE ∙ MICA ∙ IRON OXIDES ∙
🎯 Purpose ▾
Active ingredients Purpose AVOBENZONE 2.5% Sunscreen OCTINOXATE 7.4% Sunscreen OCTOCRYLENE 2.0% Sunscreen OXYBENZONE 1.0% Sunscreen