FLORMAR BB MATTE EFFECT SHEER TINTED BEAUTY CREAM SUNSCREEN BROAD SPECTRUM SPF 15 LF51 LIGHT- octinoxate cream

flormar BB Matte Effect Sheer Tinted Beauty Cream Sunscreen Broad Spectrum SPF 15 LF51 Light by

Drug Labeling and Warnings

flormar BB Matte Effect Sheer Tinted Beauty Cream Sunscreen Broad Spectrum SPF 15 LF51 Light 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]

flormar BB Cream Matte Effect Sheer Tinted Beauty Cream Sunscreen Broad Spectrum SPF 15 LF51 Light

Active Ingredient

Octinoxate 5%

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

• Wear alone or under foundation.
  
• Shake well before use.
• Apply drop by drop with fingertips.
• 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 value 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-sleeved shirts, pants, hats and sunglasses.
• Children under 6 months of age: Ask a doctor.
  

Other information

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

Inactive ingredients

water, cyclopentasiloxane, butylene glycol, nylon 12, silica, cetyl peg/ppg-10/1 dimethicone, dimethicone, peg-10 dimethicone, aluminum starch octenylsuccinate, polysilicone-11, disteardimonium hectorite, glycerin, sd alcohol 40-b, phenoxyethanol, trimethylsiloxysilicate, sodium chloride, fragrance, sodium pca, ethylhexylglycerin, uree, triethoxycaprylylsilane, aluminum hydroxide, algae extract, soluble collagen, laureth-12, trehalose,leuconostoc/radish root ferment filtrate, polyquaternium-51, sodium hyaluronate, chlorphenesin propylene glycol, fig (ficus carica) fruit extract, cotton (gossypium hirsutum) seed extract, linseed (linum usitatissimum) seed extract, sodium dehydroacetate, hexyl cinnamal, benzyl salicylate, butylphenyl methylpropional, alpha-isomethyl ionone, linalool, titanium dioxide, iron oxides

Product Labels

INGREDIENTS AND APPEARANCE

FLORMAR BB MATTE EFFECT SHEER TINTED BEAUTY CREAM SUNSCREEN BROAD SPECTRUM SPF 15 LF51 LIGHT 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61722-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
LAURETH-12 (UNII: OAH19558U1)
TREHALOSE (UNII: B8WCK70T7I)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61722-120-00	1 in 1 BOX	07/07/2014
1		40 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 not final	part352	07/07/2014

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