CLÉ DE PEAU BEAUTÉ PROTECTIVE FORTIFYING CREAM

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 00:42:42

Label at a glance#

ProductCLE DE PEAU BEAUTE PROTECTIVE FORTIFYING
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 (AQUA/EAU)∙CYCLOMETHICONE∙GLYCERIN∙DIISOPROPYL SEBACATE∙BUTYLENE GLYCOL∙DIETHYLHEXYL SUCCINATE∙SD ALCOHOL 40-B∙PEG/PPG-14/7 DIMETHYL ETHER∙TREHALOSE∙DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER∙TOCOPHERYL ACETATE∙PEG/PPG-17/4 DIMETHYL ETHER∙PHYTOSTERYL MACADAMIATE∙POLYQUATERNIUM-51∙SODIUM ACETYLATED HYALURONATE∙GINKGO BILOBA LEAF EXTRACT∙PAEONIA ALBIFLORA ROOT EXTRACT∙CRATAEGUS MONOGYNA FLOWER EXTRACT∙CAFFEINE∙SERINE∙HYDROLYZED SILK∙2-O-ETHYL ASCORBIC ACID∙BUPLEURUM FALCATUM ROOT EXTRACT∙UNCARIA GAMBIR EXTRACT∙ROSA ROXBURGHII FRUIT EXTRACT∙HYDROLYZED CONCHIOLIN PROTEIN∙BEHENETH-20∙PPG-17∙BEHENYL ALCOHOL∙CARBOMER∙POLYSORBATE 20∙TRIETHANOLAMINE∙DISODIUM EDTA∙STEARYL ALCOHOL∙HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER∙THEANINE∙SODIUM CITRATE∙SODIUM METAPHOSPHATE∙CITRIC ACID∙BHT∙ALCOHOL∙TOCOPHEROL∙PHENOXYETHANOL∙METHYLPARABEN∙BENZOIC ACID∙FRAGRANCE (PARFUM)∙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 Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

protective fortifying cream
BROAD SPECTRUM SPF 22 SUNSCREEN

DIN 02440806

50mL NET WT. 1.7 OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton
PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton

FDA-Initiated Inactive NDC Indexing#

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
58411-25858411-258-50

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 · Source PDF

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
41d44a07-c554-40c5-b9ca-b0664fc990c668acc188-7b07-42bb-b6b2-353da435c0a52023-10-20WarningsExact identifier
spl set id: 68acc188-7b07-42bb-b6b2-353da435c0a5

Reported adverse events (FAERS/openFDA)#

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