Cle De Peau Beaute Protective Fortifying N Emulsion
FDA Label NDC 58411-454

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shiseido Americas Corporation for the product Cle De Peau Beaute Protective Fortifying N (NDC 58411-454). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredientsPurpose
AVOBENZONE 2.5%Sunscreen
OCTINOXATE 7.4%Sunscreen
OCTOCRYLENE 2.0%Sunscreen
OXYBENZONE 1.0%Sunscreen

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

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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

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 ∙

Other Information

  • protect this product in this container from excessive heat and direct sun.

Questions Or Comments?

Call toll free 1-800-906-7503

Principal Display Panel - 125 Ml Container Carton

clé de peau
BEAUTÉ

PROTECTIVE FORTIFYING
EMULSON n

BROAD SPECTRUM
SPF 22
SUNSCREEN

125mL 4.2 FL. OZ.

Principal Display Panel (125 mL Container Carton)

Principal Display Panel (125 mL Container Carton)

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