cle de peau BEAUTE UV PROTECTIVE FOR BODY N

Manufacturer
Shiseido Americas Corporation | Shiseido America Inc.
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:26:32

Label at a glance#

Productcle de peau BEAUTE UV PROTECTIVE FOR BODY N
Active ingredientENSULIZOLE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE
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 Reapply:       • after 80 minutes of swimming or sweating       • immediately after towel drying       • 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 protecti...

Storage and handling

protect this product in this container from excessive heat and direct sunlight

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - PURPOSE SECTION

Active IngredientsPurpose
Ensulizole 2.0% Sunscreen
Octisalate 5.0% Sunscreen
Octocrylene 5.0% Sunscreen
Zinc Oxide 19.4%  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 - 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.

WARNINGS AND PRECAUTIONS SECTION

Flammable: Do not use near heat, flame, or while smoking

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • Reapply:

      • after 80 minutes of swimming or sweating

      • immediately after towel drying

      • 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

Uses

INACTIVE INGREDIENT SECTION

WATER・DIMETHICONE・DIISOPROPYL SEBACATE・GLYCERIN・ALCOHOL DENAT.・TRISILOXANE・PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE・SILICA・ISOPROPYL MYRISTATE・DIPHENYLSILOXY PHENYL TRIMETHICONE・ISODODECANE・TRIMETHYLSILOXYSILICATE・TRIETHANOLAMINE・DEXTRIN PALMITATE・TREHALOSE・MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT・RUBUS SUAVISSIMUS (RASPBERRY) LEAF EXTRACT・GLYCINE・PEG/PPG-14/7 DIMETHYL ETHER・HYDRANGEA SERRATA LEAF EXTRACT・THYMUS SERPYLLUM EXTRACT・SODIUM ACETYLATED HYALURONATE・AMINOETHANESULFINIC ACID・SODIUM HYALURONATE・TOCOPHERYL ACETATE・ANGELICA ACUTILOBA ROOT EXTRACT・HYDROLYZED CONCHIOLIN PROTEIN・HYDROLYZED SILK・PERILLA OCYMOIDES LEAF EXTRACT・POLYQUATERNIUM-51・PANAX GINSENG ROOT EXTRACT・SAXIFRAGA SARMENTOSA EXTRACT・GINKGO BILOBA LEAF EXTRACT・SCUTELLARIA BAICALENSIS ROOT EXTRACT・GARCINIA MANGOSTANA BARK EXTRACT・DISTEARDIMONIUM HECTORITE・HYDROGEN DIMETHICONE・ISOSTEARIC ACID・BUTYLENE GLYCOL・DISODIUM EDTA・SORBITAN SESQUIISOSTEARATE・ALCOHOL・TOCOPHEROL・BHT・SODIUM METABISULFITE・SYNTHETIC FLUORPHLOGOPITE・THEANINE・SYZYGIUM JAMBOS LEAF EXTRACT・PHENOXYETHANOL・FRAGRANCE・RED 33・YELLOW 5・YELLOW 6・

Other information

STORAGE AND HANDLING SECTION

  • protect this product in this container from excessive heat and direct sunlight

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-906-7503

PRINCIPAL DISPALY PANEL - 100 mL Container

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

UV PROTECTIVE EMULSION FOR BODY n

60+

BROAD SPECTRUM

SPF 60+

WATER RESISTANT

(80 MINUTES)

SUNSCREEN

100 mL 3.3 FL. OZ.

CPB UV protective emulsion for bodyCPB UV protective emulsion for body

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-956-40cle de peau BEAUTE UV PROTECTIVE FOR BODY N1 in 1 BOXEMULSION13
58411-956-40cle de peau BEAUTE UV PROTECTIVE FOR BODY N100 mL in 1 CONTAINEREMULSION1003

Products#

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

DailyMed product names page 1 of 2 · 57 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-95658411-956-40

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 53 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 FOR BODY NENSULIZOLE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEShiseido Americas Corporationa2bbf6f8-b8ad-4cd9-abeb-7ec0a4ddb45c2025-12-16WarningsExact identifier
ndc (package): 58411-956-40
ndc (product): 58411-956
ndc11 (package): 58411095640
spl id: 4617e90c-d282-21f4-e063-6294a90a5c41
spl set id: a2bbf6f8-b8ad-4cd9-abeb-7ec0a4ddb45c

Reported adverse events (FAERS/openFDA)#

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