FDA.reportPublic FDA data

CLÉ DE PEAU BEAUTÉ PROTECTIVE FORTIFYING CREAM n

Manufacturer
SHISEIDO AMERICAS CORPORATION | SHISEIDO AMERICA INC.
Effective date
2018-10-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:23

Label at a glance#

ProductCLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n
Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE
Label structure9 sections

Indications and 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

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 su...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
AVOBENZONE 2.0%Sunscreen
OCTINOXATE 4.9%Sunscreen
OCTOCRYLENE 5.0%Sunscreen
OXYBENZONE 2.0%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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 •

Other information

STORAGE AND HANDLING SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 50 mL Container Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

PROTECTIVE FORTIFYING CREAM n
BROAD SPECTRUM
SPF 22
SUNSCREEN

50mL NET WT. 1.8 OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Container Carton
PRINCIPAL DISPLAY PANEL - 50 mL Container Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58411-455-502025-01-30C16284748780-12cef2736-9164-d83d-e063-dadaa90ab31fCLÉ DE PEAU BEAUTÉ PROTECTIVE FORTIFYING CREAM n

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-455-50CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n50 mL in 1 CONTAINERCREAM501
58411-455-50CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-455CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING N (AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE) CREAM [SHISEIDO AMERICAS CORPORATION]1Legacy NDC, 2 package rows20190201_46133b89-9f93-4342-adaa-3e10f5193aba.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 53 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-45558411-455-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 51 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERINPDC6A3C0OXIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIETHYLHEXYL SUCCINATE69W9UMG3P8IACT
TREHALOSEB8WCK70T7IIACT
PEG/PPG-14/7 DIMETHYL ETHER6DNW9T7YT2IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
PEG/PPG-17/4 DIMETHYL ETHER4ET18WJG5KIACT
PHYTOSTERYL MACADAMIATE233VSF903MIACT
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)EL9825H96JIACT
GINKGO19FUJ2C58TIACT
ANGELICA ACUTILOBA ROOT3W51R3EK30IACT
PAEONIA LACTIFLORA ROOT3Z3866YW6PIACT
CRATAEGUS MONOGYNA FLOWERNT52AMP29JIACT
ASIAN GINSENGCUQ3A77YXIIACT
GLYCINETE7660XO1CIACT
ONONIS SPINOSA ROOTFD2FMC53M1IACT
ZANTHOXYLUM PIPERITUM FRUIT RIND728JDI7G4MIACT
SODIUM ACETYLATED HYALURONATEWN66R7GL93IACT
ROSA ROXBURGHII FRUITCVT1AA87FFIACT
BUPLEURUM FALCATUM ROOTX04E310LUYIACT
BEHENETH-20BJ4GP2IFLNIACT
PPG-17OV0Q322E0UIACT
DOCOSANOL9G1OE216XYIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
POLYSORBATE 207T1F30V5YHIACT
TROLAMINE9O3K93S3TKIACT
EDETATE DISODIUM7FLD91C86KIACT
STEARYL ALCOHOL2KR89I4H1YIACT
THEANINE8021PR16QOIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
ALCOHOL3K9958V90MIACT
SODIUM POLYMETAPHOSPHATEP1BM4ZH95LIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5bc01e07-7b00-48bd-8988-d50df503b78746133b89-9f93-4342-adaa-3e10f5193aba2018-10-29WarningsExact identifier
spl id: 5bc01e07-7b00-48bd-8988-d50df503b787
spl set id: 46133b89-9f93-4342-adaa-3e10f5193aba

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.