FLORMAR BB WHITE BW03 DARK MEDIUM- octinoxate, octocrylene, avobenzone aerosol

Flormar BB White BW03 Dark Medium by

Drug Labeling and Warnings

Flormar BB White BW03 Dark Medium 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 ingredients

Octinoxate 5%

Octinoxate 2%

Avobenzone 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

• Wear alone or under foundation.
• 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 your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 30 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.
• Childrenn under 6 months of age: Ask a doctor.

Other information

• Protect the product in this container from excessive heat and direct sun.
• Keep the product cool.
• After use, close the tube properly with cap.

Inactive ingredients

Water, cyclopentasiloxane, polysilicone-11, butylene glycol, cetyl PEG/PPG-10/1 dimethicone, PEG-10 dimethicone, trimethylsiloxysilicate, disteardimonium hectorite, SD alcohol 40-B, phenoxyethanol, polyglyceryl-3 polydimethyl siloxyethyl dimethicone, hydrolyzed vegetable flour, ascorbyl tetraisopalmitate, polymethylsilsesquioxane, sodium chloride, stearic acid, methyl methacrylate crosspolymer, silica, fragrance, ethylhexylglycerin, triethoxycaprylylsilane, aluminum hydroxide, laureth-12, caprylyl glycol, hexyl cinnamal benzyl salicylate, butylphenyl methylpropional, alpha-isomethyl ionone,linalool, may contain: titanium dioxide, iron oxides.

Package Labeling:

INGREDIENTS AND APPEARANCE

FLORMAR BB WHITE BW03 DARK MEDIUM 
octinoxate, octocrylene, avobenzone aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61722-292
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
LAURETH-12 (UNII: OAH19558U1)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61722-292-00	1 in 1 BOX	05/02/2016
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	05/02/2016

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