FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE  COCOA - octinoxate, titanium dioxide cream 
ELIZABETH ARDEN, INC

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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Drug Facts

Active Ingredients

OCTINOXATE 5.00%

TITANIUM DIOXIDE 3.90%

Purpose

Sunscreen

Sunscreen

Uses

Warnings

  • 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.

Directions For Sunscreen Use:

Inactive Ingredients

WATER/AQUA/EAU, CYCLO- PENTASILOXANE, ETHYLHEXYL ISONONANOATE, POLYMETHYL- SILSESQUIOXANE, DIMETHICONE, BUTYLENE GLYCOL, GLYCERIN, NYLON-12, ISODODECANE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ALCOHOL DENAT., MICA, C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER, BORON NITRIDE, ACRYLATES/C12-22 ALKYL METHACRYLATE COPOLYMER, ALUMINUM DIMYRISTATE, BAMBUSA ARUNDINACEA STEM POWDER, CITRIC ACID, CYCLOHEXA- SILOXANE, DIMETHICONE/ PEG-10/15 CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIPROPYLENE GLYCOL DISODIUM EDTA, DISODIUM STEAROYL GLUTAMATE, HYDROXYETHYL- CELLULOSE, LAUROYL LYSINE, LECITHIN, MAGNESIUM SULFATE, PENTYLENE GLYCOL, POLYSORBATE 60, SACCHARIDE ISOMERATE, SILICA, SODIUM CITRATE, SORBITAN STEARATE, TOCOPHEROL, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYL- SILANE, ZINC GLYCYRRHETINATE, BHT, CHLORPHENESIN, PHENOXYETHANOL, POTASSIUM SORBATE [MAY CONTAIN/PEUT CONTENIR (+/-) IRON OXIDES (Cl 77491, Cl 77492, Cl 77499), TITANIUM DIOXIDE (Cl 77891).

Other Information

Questions or comments?

Principal Display Panel - Box Label

Elizabeth Arden
NEW YORK

Flawless Finish
Perfectly Satin
24HR

Makeup

Broad Spectrum

Sunscreen SPF 15

1 FL. OZ.

30 ml

Principal Display Panel - Box Label
FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE   COCOA
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-2058
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.725 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.346 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
MICA (UNII: V8A1AW0880)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISODODECANE (UNII: A8289P68Y2)  
NYLON-12 (UNII: 446U8J075B)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
ALCOHOL (UNII: 3K9958V90M)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MAGNESIUM SULFATE (UNII: DE08037SAB)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
LAUROYL LYSINE (UNII: 113171Q70B)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
BAMBUSA BAMBOS STEM (UNII: NRA4497HC5)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TOCOPHEROL (UNII: R0ZB2556P8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67938-2058-11 in 1 BOX
1NDC:67938-2058-230 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/05/2015
Labeler - ELIZABETH ARDEN, INC (849222187)
Establishment
NameAddressID/FEIBusiness Operations
KOLMAR001535103MANUFACTURE(67938-2058)

Revised: 1/2015
Document Id: 54e42258-e2d0-4907-9b9c-e91b1d64ff03
Set id: eb3631c2-3c1e-48f8-8032-9337b7ab3088
Version: 1
Effective Time: 20150105
 
ELIZABETH ARDEN, INC