cle de peau BEAUTE UV PROTECTIVE CREAM N

Manufacturer
Shiseido Americas Corporation | Shiseido America Inc.
Effective date
2025-05-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:00:40

Label at a glance#

Productcle de peau BEAUTE UV PROTECTIVE N
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure13 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 sun...

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 2.3%Sunscreen 
Homosalate 10.0% Sunscreen 
Octisalate 5.0%Sunscreen 
Octocrylene 5.0% 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 useon damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctorif 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・BUTYLENE GLYCOL・GLYCERIN・SILICA・DIPROPYLENE GLYCOL・SD ALCOHOL 40-B・GLYCERYL DIISOSTEARATE・CAPRYLYL METHICONE・BEHENYL ALCOHOL・C30-45 ALKYL METHICONE・DIMETHICONE・AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER・XANTHAN GUM・TREHALOSE・TOCOPHERYL ACETATE・2-O-ETHYL ASCORBIC ACID・SCUTELLARIA BAICALENSIS ROOT EXTRACT・FAGUS SYLVATICA BUD EXTRACT・GLYCINE・PEG/PPG-14/7 DIMETHYL ETHER・THYMUS SERPYLLUM EXTRACT・GARCINIA MANGOSTANA BARK EXTRACT・PANAX GINSENG ROOT EXTRACT・AMINOETHANESULFINIC ACID・BUPLEURUM FALCATUM ROOT EXTRACT・ANGELICA ACUTILOBA ROOT EXTRACT・HYDROLYZED CONCHIOLIN PROTEIN・HYDROLYZED SILK・PERILLA OCYMOIDES LEAF EXTRACT・POLYQUATERNIUM-51・CRATAEGUS MONOGYNA FLOWER EXTRACT・SAXIFRAGA SARMENTOSA EXTRACT・GINKGO BILOBA LEAF EXTRACT・MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT・BEHENETH-20・C30-45 OLEFIN・STEARYL ALCOHOL・DISODIUM EDTA・CARBOMER・POTASSIUM HYDROXIDE・TOCOPHEROL・SODIUM METAPHOSPHATE・BHT・MICA・ALCOHOL・SODIUM METABISULFITE・THEANINE・SYZYGIUM JAMBOS LEAF EXTRACT・CHLORPHENESIN・PHENOXYETHANOL・FRAGRANCE・IRON OXIDES・TITANIUM DIOXIDE・

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

CPB UV Protective Cream nCPB UV Protective Cream n

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-905-60cle de peau BEAUTE UV PROTECTIVE N50 mL in 1 TUBECREAM502
58411-905-60cle de peau BEAUTE UV PROTECTIVE N1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-905CLE DE PEAU BEAUTE UV PROTECTIVE N (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]2Current NDC, 2 package rows20250509_fe19a057-a3c6-4c53-92f9-a4a960cd5b08.zip

Products#

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

DailyMed product names page 1 of 2 · 58 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-90558411-905-60

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 55 matching rows.

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
cle de peau BEAUTE UV PROTECTIVE NAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationfe19a057-a3c6-4c53-92f9-a4a960cd5b082025-05-07WarningsExact identifier
ndc (package): 58411-905-60
ndc (product): 58411-905
ndc11 (package): 58411090560
spl id: 34907910-b27e-0fee-e063-6294a90aecb7
spl set id: fe19a057-a3c6-4c53-92f9-a4a960cd5b08

Reported adverse events (FAERS/openFDA)#

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