FLORMAR REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP30 CARAMEL- octinoxate powder

FLORMAR REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP30 Caramel by

Drug Labeling and Warnings

FLORMAR REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP30 Caramel 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 5%

Purpose

sunscreen

Uses

• Helps prevent sunburn.
• If used as direct 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

• Apply to face with a make-up sponge.
• 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 Bord 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

neopentyl glycol diethylhexanoate, ethylhexyl palmitate, polyethylene, hydrogenated polysiobutene, isononyl isononanoate, octyldodecyl stearoyl stearate, aluminum starch octenyl succinate, candelilla (Candelilla cera) wax, pentaerythrityl tetrabehenate, isocetyl stearoyl stearate, jojoba (Simmondsia chinensis) seed oil, squalane, nylon-12, polyglyceryl-3 diisostearate, cyclopentasiloxane, polymethylsilsesquioxane, dimethicone/vinyl dimethicone crosspolymer, triethoxycaprylylsilane, aluminum hydroxide, fragrance, polyglyceryl-3 polydimethyl siloxyethyl dimethicone, silica, stearic acid, PEG-8, tocopherol, ascorbyl palmitate, ascorbic acid, citric acid, linalool, butylphenyl methylpropional, alpha-isomethyl ionone, citronellol, benzyl salicylate, geraniol, coumarin, titanium dioxide, iron oxides.

Kosan Kozmetlk Sanayl ve Ticaret A.S.

Gebze Organize Sanayi Bolgesi Ihsan Dede Cad.900.SK NO:133 Gebze, Kocaeli 41480 Turkey

Made in Turkey  www.flormar.com

A Cream that creates the appearance of all day skin prefection with sensorial comfort. Extreme wearing, light texture adapts to the skin's movements with a medium to high covering film. Glides on with a velvet soft feel that stays lightweight, soft and smooth. application: Wash abd rinse your latex sponge when you are finished with your application. Before you put your latex sponge into the container, be sure that it is dried. Keep away from direct sunlight and keep in a cool place. After use, close the cap properly.

To report a serious adverse event contact [917] 768-7350.

PRINCIPAL DISPLAY PANEL

Flormar  REBORN   BB CREAM  SUNSCREEN BROAD SPECTRUM SPF 30   Net Wt. 0.42 oz (12 g)

Product Label

INGREDIENTS AND APPEARANCE

FLORMAR REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP30 CARAMEL 
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61722-171
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 g

Inactive Ingredients
Ingredient Name	Strength
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CANDELILLA WAX (UNII: WL0328HX19)
PENTAERYTHRITYL TETRABEHENATE (UNII: 9MNZ044IRY)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
JOJOBA OIL (UNII: 724GKU717M)
SQUALANE (UNII: GW89575KF9)
NYLON-12 (UNII: 446U8J075B)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61722-171-00	1 in 1 CARTON	10/24/2014
1		12 g in 1 BOX; 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	10/24/2014

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