FRESH UMBRIAN CLAY FRESHFACE FOUNDATION SPF 20 SEVENTH VEIL- octinoxate emulsion 
Guerlain

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients: Octinoxate 3%

Warnings: Avoid contact with the eyes. For external use only.

Keep out of reach of children. Discontinue use if signs of

irritation or rash appear.

PRINCIPAL DISPLAY PANEL

Fresh

UMBRIAN CLAY

Freshface

FOUNDATION

SPF 20

SEVENTH VEIL


30ml   1floz

Fresh Inc Boston 02118 USA


image of carton

FRESH UMBRIAN CLAY FRESHFACE FOUNDATION SPF 20 SEVENTH VEIL 
octinoxate emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49817-1997
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
LOCUST BEAN GUM (UNII: V4716MY704)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
JOJOBA OIL (UNII: 724GKU717M)  
WHITE WAX (UNII: 7G1J5DA97F)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
EDETATE SODIUM (UNII: MP1J8420LU)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49817-1997-51 in 1 CARTON
1NDC:49817-1997-933 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/200909/23/2015
Labeler - Guerlain (266623064)
Establishment
NameAddressID/FEIBusiness Operations
Guerlain266623064manufacture(49817-1997)

Revised: 9/2015
Document Id: 206eacbd-c696-6d72-e054-00144ff8d46c
Set id: 2978a09c-b0f3-4c20-81a3-b1b57fbc9b42
Version: 3
Effective Time: 20150923
 
Guerlain