FDA.reportPublic FDA data

CLE DE PEAU BEAUTE UV PROTECTIVE LIP TREATMENT

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 00:42:56

Label at a glance#

ProductCLE DE PEAU BEAUTE UV PROTECTIVE LIP TREATMENT
Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE
Label structure9 sections

Indications and uses

helps prevent sunburn

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 2.5%Sunscreen
OCTINOXATE 4.9%Sunscreen
OCTOCRYLENE 3.0%Sunscreen
OXYBENZONE 2.0%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

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

DIISOSTEARYL MALATE•TRIETHYLHEXANOIN•HYDROGENATED POLYISOBUTENE•TRIISOSTEARIN•PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE•POLYETHYLENE•MICROCRYSTALLINE WAX•WATER•BUTYLENE GLYCOL•GLYCERIN•POLYGLYCERYL-2 DIISOSTEARATE•TOCOPHERYL ACETATE•PEG/PPG-36/41 DIMETHYL ETHER•ARGANIA SPINOSA KERNEL OIL•STEARYL GLYCYRRHETINATE•MORTIERELLA OIL•GINKGO BILOBA LEAF EXTRACT•THYMUS SERPYLLUM EXTRACT•PANAX GINSENG ROOT EXTRACT•SODIUM ACETYLATED HYALURONATE•SODIUM HYALURONATE•SILICA DIMETHYL SILYLATE•LITHIUM MAGNESIUM SODIUM SILICATE•TOCOPHEROL•SIMETHICONE•BHT•ALCOHOL•TRIMETHYLOLPROPANE TRIETHYLHEXANOATE•METHICONE•TETRADECENE•FRAGRANCE•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 - 4 g Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

30

UV protective
lip treatment

BROAD SPECTRUM
SPF 30
SUNSCREEN

4g NET WT. .14 OZ.

Principal Display Panel - 4 g Bottle Carton
Principal Display Panel - 4 g Bottle Carton

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-28858411-288-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIISOSTEARYL MALATEQBS8A3XZGQIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
TRIISOSTEARIN71503RH8KGIACT
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE65954KGO9QIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERINPDC6A3C0OXIACT
POLYGLYCERYL-2 DIISOSTEARATEDG195GP57PIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
PEG/PPG-36/41 DIMETHYL ETHERGZ406N3R9FIACT
ARGAN OIL4V59G5UW9XIACT
STEARYL GLYCYRRHETINATE3YYE6VJS0PIACT
GINKGO19FUJ2C58TIACT
THYMUS SERPYLLUM86H4S6K51NIACT
ASIAN GINSENGCUQ3A77YXIIACT
SODIUM ACETYLATED HYALURONATEWN66R7GL93IACT
HYALURONATE SODIUMYSE9PPT4THIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
LAPONITED703131383IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ALCOHOL3K9958V90MIACT
TRIMETHYLOLPROPANE TRIETHYLHEXANOATEB952ZGW1ILIACT
METHICONE (20 CST)6777U11MKTIACT
TETRADECENEFW23481S7SIACT
FERRIC OXIDE RED1K09F3G675IACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB

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
eefc6739-0bf3-416e-9ddd-4802a052203fd83be914-a29c-41f2-91bb-ba678d6e4d382024-12-20WarningsExact identifier
spl set id: d83be914-a29c-41f2-91bb-ba678d6e4d38

Reported adverse events (FAERS/openFDA)#

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