CLE DE PEAU BEAUTE UV PROTECTIVE N- avobenzone, homosalate, octisalate, octocrylene cream

cle de peau BEAUTE UV PROTECTIVE N by

Drug Labeling and Warnings

cle de peau BEAUTE UV PROTECTIVE 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
• Avobenzone 2.3%: Sunscreen
• Homsalate 10%: Sunscreen
• Octisalate 5%: Sunscreen
• Octocrylene 5%: 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 useon damaged or broken skin

WHEN USING

When using this productkeep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctorif 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.

Directions

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. - 2p.m.
•    wear long-sleeve shirts, pant, hats, and sunglasses
• children under 6 months: Ask a doctor

INACTIVE INGREDIENT

WATER･BUTYLENE GLYCOL･GLYCERIN･SILICA･DIPROPYLENE GLYCOL･SD ALCOHOL 40-B･GLYCERYL DIISOSTEARATE･CAPRYLYL METHICONE･BEHENYL ALCOHOL･C30-45 ALKYL METHICONE･DIMETHICONE･AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER･XANTHAN GUM･TREHALOSE･TOCOPHERYL ACETATE･2-O-ETHYL ASCORBIC ACID･SCUTELLARIA BAICALENSIS ROOT EXTRACT･FAGUS SYLVATICA BUD EXTRACT･GLYCINE･PEG/PPG-14/7 DIMETHYL ETHER･THYMUS SERPYLLUM EXTRACT･GARCINIA MANGOSTANA BARK EXTRACT･PANAX GINSENG ROOT EXTRACT･AMINOETHANESULFINIC ACID･BUPLEURUM FALCATUM ROOT EXTRACT･ANGELICA ACUTILOBA ROOT EXTRACT･HYDROLYZED CONCHIOLIN PROTEIN･HYDROLYZED SILK･PERILLA OCYMOIDES LEAF EXTRACT･POLYQUATERNIUM-51･CRATAEGUS MONOGYNA FLOWER EXTRACT･SAXIFRAGA SARMENTOSA EXTRACT･GINKGO BILOBA LEAF EXTRACT･MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT･BEHENETH-20･C30-45 OLEFIN･STEARYL ALCOHOL･DISODIUM EDTA･CARBOMER･POTASSIUM HYDROXIDE･TOCOPHEROL･SODIUM METAPHOSPHATE･BHT･MICA･ALCOHOL･SODIUM METABISULFITE･THEANINE･SYZYGIUM JAMBOS LEAF EXTRACT･CHLORPHENESIN･PHENOXYETHANOL･FRAGRANCE･IRON OXIDES･TITANIUM DIOXIDE･

Other Information

• protect this product in this container from excessive heat and direct sun.

Questions or Comments?

Call toll free 1-800-906-7503

PRINCIPLE DISPLAY PANNEL 50 mL TUBE

cle de peau

BEAUTE

UV PROTECTIVE CREAM n

50+

BROAD SPECTRUM

SPF 50+

SUNSCREEN

50mL NET WT. 1.8 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE UV PROTECTIVE N 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-968
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.19715 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5.205 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	2.6025 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.6025 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
SILICA (UNII: ETJ7Z6XBU4)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
DIMETHICONE (UNII: 92RU3N3Y1O)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)
XANTHAN GUM (UNII: TTV12P4NEE)
TREHALOSE (UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I)
ASIAN GINSENG (UNII: CUQ3A77YXI)
AMINOETHANESULFINIC ACID (UNII: 5L08GE4332)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
GINKGO (UNII: 19FUJ2C58T)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARBOMER (UNII: 0A5MM307FC)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)
BHT (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
ALCOHOL (UNII: 3K9958V90M)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
THEANINE (UNII: 8021PR16QO)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-968-60	1 in 1 BOX	04/01/2025
1		50 mL in 1 TUBE; 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	04/01/2025

Labeler - Shiseido Americas Corporation (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	manufacture(58411-968) , analysis(58411-968)