CLE DE PEAU BEAUTE BRIGHTENING ENHANCER VEIL- octinoxate, octocrylene, and titanium dioxide emulsion

cle de peau BEAUTE BRIGHTENING ENHANCER VEIL by

Drug Labeling and Warnings

cle de peau BEAUTE BRIGHTENING ENHANCER 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
Octinoxate 7.4%	Sunscreen
Octocrylene 2.5%	Sunscreen
Titanium Dioxide 6.6%	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 product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if 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 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 value 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

WATERDIMETHICONETRISILOXANEBUTYLENE GLYCOLGLYCERINISOPROPYL MYRISTATESD ALCOHOL 40-BPEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONESILICABARIUM SULFATEPOTASSIUM METHOXYSALICYLATETREHALOSEHYDROGENATED POLYISOBUTENESODIUM POLYACRYLATETOCOPHERYL ACETATEGLYCINECAMELLIA SINENSIS LEAF EXTRACTPEG/PPG-14/7 DIMETHYL ETHERROSA ROXBURGHII FRUIT EXTRACTANGELICA ACUTILOBA ROOT EXTRACTHYDROLYZED CONCHIOLIN PROTEINHYDROLYZED SILKPERILLA OCYMOIDES LEAF EXTRACTPPG-17ALUMINUM HYDROXIDEDISTEARDIMONIUM HECTORITEHYDROGEN DIMETHICONESTEARIC ACIDTRISODIUM EDTABUTYROSPERMUM PARKII (SHEA) BUTTERCITRIC ACIDSODIUM CITRATEALCOHOLTALCBHTTOCOPHEROLSODIUM METABISULFITEPOLYSILICONE-2THEANINEBIS-BUTYLDIMETHICONE POLYGLYCERYL-3PHENOXYETHANOLFRAGRANCETITANIUM DIOXIDEIRON OXIDES

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 Bottle Box

clé de peau
BEAUTÉ

BRIGHTENING
ENHANCER VEIL

BROAD SPECTRUM
SPF 32
SUNSCREEN

30mL 1 FL. OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE BRIGHTENING ENHANCER VEIL 
octinoxate, octocrylene, and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-838
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2220 mg  in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	750 mg  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1980 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRISILOXANE (UNII: 9G1ZW13R0G)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BARIUM SULFATE (UNII: 25BB7EKE2E)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
TREHALOSE (UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCINE (UNII: TE7660XO1C)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
PPG-17 (UNII: OV0Q322E0U)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
SHEA BUTTER (UNII: K49155WL9Y)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ALCOHOL (UNII: 3K9958V90M)
TALC (UNII: 7SEV7J4R1U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-838-10	1 in 1 BOX	04/01/2022
1		30 mL in 1 BOTTLE; 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	04/01/2022

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	ANALYSIS(58411-838) , MANUFACTURE(58411-838)