FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE SOFT SHELL- octinoxate, titanium dioxide cream

FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE by

Drug Labeling and Warnings

FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE by is a Otc medication manufactured, distributed, or labeled by ELIZABETH ARDEN, INC, KOLMAR. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OCTINOXATE 5.00%

TITANIUM DIOXIDE 3.90%

Purpose

Sunscreen

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.

Directions For Sunscreen Use:

• Apply liberally 15 minutes before sun exposure
• Reapply:
  • at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
• 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/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

• Protect this product from excessive heat and direct sun

Questions or comments?

• Call toll free 1-800 326-7337

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

INGREDIENTS AND APPEARANCE

FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE   SOFT SHELL
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-2061
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.725 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.346 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-2061-1	1 in 1 BOX
1	NDC: 67938-2061-2	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 not final	part352	01/05/2015

Labeler - ELIZABETH ARDEN, INC (849222187)

Establishment
Name	Address	ID/FEI	Business Operations
KOLMAR		001535103	MANUFACTURE(67938-2061)