FLORMAR PERFECT COVERAGE FOUNDATION 115 TOFFEE- octinoxate cream

Flormar Perfect Coverage Foundation 115 Toffee by

Drug Labeling and Warnings

Flormar Perfect Coverage Foundation 115 Toffee by is a Otc medication manufactured, distributed, or labeled by Kosan Kozmetik Sanayi ve Ticaret A.S.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Octinoxate 1%

Purpose

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Shake well before 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 cancer and early skin aging.  To decrease this risk, regularly use a Broad Spectrum SPF value of15 or higher and other sun protection measures including:
• Limit timein the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats and sunglasses.
• Children under 6 months of age:  Ask a doctor.

Other information

Protect this product in this container from excessive heat and direct sun

Inactive ingredients

water, cyclopentasiloxane, isononyl isononanoate, diethylhexyl malate, butylene glycol, sorbitan olivate, HDI/trimethylol hexylactone crosspolymer, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, magnesium aluminum silicate, glycerin, sweet almond (Prunus amygdalus dulcis) oil, polyglyceryl-4 isostearate, hydrogenated olive (Olea europaea) oil, phenoxyethanol, aluminum hydroxide, polyglyceryl-3 polydimethyl siloxyethyl dimethicone, triethoxycaprylylsilane, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, olive (Olea europaea) fruit oil, stearic acid, bisabolol, fragrance, methylparaben, propylene glycol, olive (Olea europaea) oil unsaponifiables, PEG-8, silica, tocopherol, glyceryl acrylate/acrylic acid copolymer, ascorbyl palmitate, PVM/MA copolymer, ascorbic acid, citric acid, propylparaben, linalool, butylphenyl methylpropional, alpha-isomethyl ionone, citronellol, benzyl salicylate, citronellol, benzyl salicylate, geraniol, coumarin, titanium dioxide, iron oxides.

Package Labeling:

INGREDIENTS AND APPEARANCE

FLORMAR PERFECT COVERAGE FOUNDATION 115 TOFFEE 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61722-260
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
GERANIOL (UNII: L837108USY)
COUMARIN (UNII: A4VZ22K1WT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
DIETHYLHEXYL MALEATE (UNII: C2F7JHI12L)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SORBITAN OLIVATE (UNII: MDL271E3GR)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
ALMOND OIL (UNII: 66YXD4DKO9)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
OLIVE OIL (UNII: 6UYK2W1W1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
XANTHAN GUM (UNII: TTV12P4NEE)
STEARIC ACID (UNII: 4ELV7Z65AP)
LEVOMENOL (UNII: 24WE03BX2T)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61722-260-00	1 in 1 BOX	09/27/2015
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 not final	part352	09/27/2015

Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)