CLE DE PEAU BEAUTE UV PROTECTIVE FOR BODY N- ensulizole, octisalate, octocrylene, zinc oxide emulsion

cle de peau BEAUTE UV PROTECTIVE FOR BODY N by

Drug Labeling and Warnings

cle de peau BEAUTE UV PROTECTIVE FOR BODY N by is a Otc medication manufactured, distributed, or labeled by Shiseido Americas Corporation, Shiseido America Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

PURPOSE

• Active Ingredients: Purpose
• Ensulizole 2.0%: Sunscreen
• Octisalate 5.0%: Sunscreen
• Octocrylene 5.0%: Sunscreen
• Zinc Oxide 19.4%: Sunscreen

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

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

WARNINGS AND PRECAUTIONS

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

Directions

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

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

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

Questions or Comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPALY PANEL - 100 mL Container

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.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE UV PROTECTIVE FOR BODY N 
ensulizole, octisalate, octocrylene, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-956
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	2.384 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	5.96 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5.96 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	23.1248 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
ISOSTEARIC ACID (UNII: X33R8U0062)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE SODIUM (UNII: MP1J8420LU)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
THEANINE (UNII: 8021PR16QO)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
TRISILOXANE (UNII: 9G1ZW13R0G)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
SILICA (UNII: ETJ7Z6XBU4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
ISODODECANE (UNII: A8289P68Y2)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
TREHALOSE (UNII: B8WCK70T7I)
MENTHA PIPERITA (PEPPERMINT) LEAF (UNII: A389O33LX6)
RUBUS CHINGII VAR. SUAVISSIMUS LEAF (UNII: U5KPW4NCFM)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDRANGEA SERRATA LEAF (UNII: 2SFZ1X3QA9)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
AMINOETHANESULFINIC ACID (UNII: 5L08GE4332)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
PANAX GINSENG ROOT (UNII: CUQ3A77YXI)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
GINKGO BILOBA LEAF (UNII: 19FUJ2C58T)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-956-40	1 in 1 BOX	12/16/2025
1		100 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/16/2025

Labeler - Shiseido Americas Corporation (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	manufacture(58411-956) , analysis(58411-956)