CLE DE PEAU BEAUTE PORE-REFINING MATTIFYING VEIL- avobenzone, octinoxate, octisalate, octocrylene paste

cle de peau BEAUTE PORE-REFINING MATTIFYING VEIL by

Drug Labeling and Warnings

cle de peau BEAUTE PORE-REFINING MATTIFYING 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

PURPOSE

• Active Ingredients: Purpose
• AVOBENZONE 2.5%: Sunscreen
• OCTINOXATE 7.4%: Sunscreen
• OCTISALATE 5%: Sunscreen
• OCTOCRYLENE 3%: 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･DIMETHICONE･DIPROPYLENE GLYCOL･METHYL METHACRYLATE CROSS POLYMER･DIMETHICONE CROSSPOLYMER･GLYCERIN･POLYSORBATE 20･DIPEPTIDE-15･BARIUM SULFATE･AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER･TREHALOSE･ARGANIA SPINOSA KERNEL OIL･PEG-60 HYDROGENATED CASTOR OIL ･GLYCINE ･PEG/PPG-14/7 DIMETHYLE ETHER･ROSA ROXBURGHII FRUIT EXTRACT･ANGELICA ACUTILOBA ROOT EXTRACT･HYDROLYZED CONCHIOLIN PROTEIN･HYDRALIZED SILK･DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER･ PERILLA OCYMOIDES LEAF EXTRACT･PEG-10 DIMETHICONE･PPG-17･PEG-20 GLYCERYL ISOSTEARATE･AMMONIUM ACRYLOYLDIMETHYLTAU-RATE/VP COPOLYMER･PPG-8-CETETH-20･ISOSTEARIC ACID･SODIUM METAPHOSPHATE･SODIUM CITRATE･CITRIC ACID･BHT･BUTYLENE GLYCOL･SILICA･THEANINE･ALUMINUM HYDROXIDE ･TRIETHOXYCAPRYLYLSILANE･TOCOPHEROL ･POLYMETHYLSILSESQUIOXANE･ PHENOXYETHANOL･METHYLPARABEN･ETHYLPARABEN ･FRAGRANCE･IRON OXIDES･MICA･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

PRINCIPAL DISPLAY PANEL- 38ml Tube

cle de peau BEAUTE

PORE-REFINING

MATTIFYING VEIL

BROAD SPECTRUM

SPF 25

SUNSCREEN

38mL NET WT. 1.4 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE PORE-REFINING MATTIFYING VEIL 
avobenzone, octinoxate, octisalate, octocrylene paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-957
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.9747 g  in 38 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.885112 g  in 38 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	1.9494 g  in 38 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.16964 g  in 38 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DIPEPTIDE-15 (UNII: 10525P22U0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)
TREHALOSE (UNII: B8WCK70T7I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PPG-17 (UNII: OV0Q322E0U)
PEG-20 GLYCERYL ISOSTEARATE (UNII: ABV7KNA149)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
PPG-8-CETETH-20 (UNII: MAL0SND89Q)
ISOSTEARIC ACID (UNII: X33R8U0062)
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID (UNII: 2968PHW8QP)
BHT (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICA (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-957-60	1 in 1 BOX	12/01/2019
1		38 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	12/01/2019

Labeler - Shiseido Americas Corporation (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	manufacture(58411-957) , analysis(58411-957)