CLE DE PEAU BEAUTE LONG-LASTING HYDRATING VEIL- avobenzone, octinoxate, and octocrylene emulsion

cle de peau BEAUTE LONG-LASTING HYDRATING VEIL by

Drug Labeling and Warnings

cle de peau BEAUTE LONG-LASTING HYDRATING VEIL 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

ACTIVE INGREDIENT

Active ingredients	Purpose
AVOBENZONE 2.5%	Sunscreen
OCTINOXATE 7.4%	Sunscreen
OCTOCRYLENE 2.0%	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 on damaged or broken skin

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

Stop use and ask a doctorif rash occurs.

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

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

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every two 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

WATER▪SD ALCOHOL 40-B▪BUTYLENE GLYCOL▪GLYCERIN▪DIMETHICONE▪TALC▪METHYL METHACRYLATE CROSSPOLYMER▪BARIUM SULFATE▪PEG/PPG-19/19 DIMETHICONE▪HYDROGENATED POLYISOBUTENE▪ERYTHRITOL▪XYLITOL▪TREHALOSE▪ARGANIA SPINOSA KERNEL OIL▪XANTHAN GUM▪POLYQUATERNIUM-51▪GLYCINE▪PEG/PPG-14/7 DIMETHYL ETHER▪TRIMETHYLSILOXYSILICATE▪ROSA ROXBURGHII FRUIT EXTRACT▪ANGELICA ACUTILOBA ROOT EXTRACT▪HYDROLYZED CONCHIOLIN PROTEIN▪HYDROLYZED SILK▪DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER▪PERILLA OCYMOIDES LEAF EXTRACT▪PPG-17▪DISODIUM EDTA▪TRIETHANOLAMINE▪PEG-60 GLYCERYL ISOSTEARATE▪CARBOMER▪SILICA▪ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER▪SODIUM METAPHOSPHATE▪BHT▪TOCOPHEROL▪SODIUM CITRATE▪SODIUM METABISULFITE▪THEANINE▪CITRIC ACID▪POLYMETHYLSILSESQUIOXANE▪ALUMINUM HYDROXIDE▪TRIETHOXYCAPRYLYLSILANE▪METHYLPARABEN▪PHENOXYETHANOL▪FRAGRANCE▪IRON OXIDES▪TITANIUM DIOXIDE▪MICA▪

Other information

Protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

clé de peau

BEAUTÉ

LONG-LASTING
HYDRATING VEIL

BROAD SPECTRUM
SPF 21
SUNSCREEN

30mL 1 FL. OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE LONG-LASTING HYDRATING VEIL 
avobenzone, octinoxate, and octocrylene emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-623
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.795 g  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.38 g  in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.635 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
TALC (UNII: 7SEV7J4R1U)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
XYLITOL (UNII: VCQ006KQ1E)
ERYTHRITOL (UNII: RA96B954X6)
PPG-17 (UNII: OV0Q322E0U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TROLAMINE (UNII: 9O3K93S3TK)
PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)
METHYLPARABEN (UNII: A2I8C7HI9T)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GLYCINE (UNII: TE7660XO1C)
THEANINE (UNII: 8021PR16QO)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
MICA (UNII: V8A1AW0880)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-623-60	1 in 1 CARTON	01/01/2021
1		30 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	01/01/2021

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	analysis(58411-623) , manufacture(58411-623)