CLE DE PEAU BEAUTE UV PROTECTIVE FOR BODY

Manufacturer
SHISEIDO AMERICAS CORPORATION | SHISEIDO AMERICA INC.
Effective date
2018-12-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:42:40

Label at a glance#

ProductCLE DE PEAU BEAUTE UV PROTECTIVE FOR BODY
Active ingredientOCTINOXATE, OCTOCRYLENE, OXYBENZONE, ZINC OXIDE
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

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 ...

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
OCTINOXATE 2.9%Sunscreen
OCTOCRYLENE 5.0%Sunscreen
OXYBENZONE 2.0%Sunscreen
ZINC OXIDE 9.6%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.

Flammable

SPL UNCLASSIFIED SECTION

Do not use near heat, flame, or while smoking

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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•DIMETHICONE•GLYCERIN•BUTYLENE GLYCOL•SD ALCOHOL 40-B•CAPRYLYL METHICONE•TALC•HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER•PEG/PPG-14/7 DIMETHYL ETHER•TREHALOSE•XANTHAN GUM•TOCOPHERYL ACETATE•POLYQUATERNIUM-51•SODIUM ACETYLATED HYALURONATE•DIPOTASSIUM GLYCYRRHIZATE•SAXIFRAGA SARMENTOSA EXTRACT•GINKGO BILOBA LEAF EXTRACT•THYMUS SERPILLUM EXTRACT•HYDROLYZED SILK•SCUTELLARIA BAICALENSIS ROOT EXTRACT•GARCINIA MANGOSTANA BARK EXTRACT•HIBISCUS SABDARIFFA FLOWER EXTRACT•PANAX GINSENG ROOT EXTRACT•BUPLEURUM FALCATUM ROOT EXTRACT•HYDROLYZED CONCHIOLIN PROTEIN•BEHENETH-20•BEHENYL ALCOHOL•HYDROGEN DIMETHICONE•STEARYL ALCOHOL•ISOSTEARIC ACID•HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER•ALCOHOL•CITRIC ACID•SILICA•BHT•DISODIUM EDTA•SODIUM METABISULFITE•SODIUM CITRATE•TOCOPHEROL•THEANINE•METHYLPARABEN•PHENOXYETHANOL•FRAGRANCE•TITANIUM DIOXIDE•MICA•

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 - 75 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

30

UV protective emulsion
for body

BROAD SPECTRUM
SPF 30
SUNSCREEN

75mL 2.5 FL. OZ.

PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58411-290-102023-12-20C16284748780-19d75b9cf-e885-f424-e053-dadaa90a57ceCLÉ DE PEAU BEAUTÉ UV PROTECTIVE FOR BODY
58411-290-102020-01-31C16284748780-19d75b9cf-e885-f424-e053-dadaa90a57ceCLÉ DE PEAU BEAUTÉ UV PROTECTIVE FOR BODY

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-29058411-290-10

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 44 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
3153189f-bbac-4b3f-81f4-0073dde069b85f4e86da-6d8f-4a3c-a6fd-9cd1ec5ec87f2023-10-23WarningsExact identifier
spl set id: 5f4e86da-6d8f-4a3c-a6fd-9cd1ec5ec87f

Reported adverse events (FAERS/openFDA)#

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