FLORMAR REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF04 RICH BEIGE- octinoxate cream

flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF04 Rich Beige by

Drug Labeling and Warnings

flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF04 Rich Beige 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 REBORN FOUNDATION CREAM SUNSCREEN BROAD SPECTRUM SPF 20 SF04 Rich Beige

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

• 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, cetyl PEG/PPG-10/1 dimethicone, dimethicone, PEG-10 dimethicone, propanediol, polysilicone-11, glycerin, SD alcohol 40-B, dimethicone/vinyl dimethicone crosspolymer, phenoxyethanol, disteardimonium hectorite, trimethylsiloxysilicate, methyl methacrylate crosspolymer, sodium chloride, triethoxycaprylysilane, aluminum hydroxide, sodium PCA, ethylhexylglycerin, fragrance, urea, Anogeissus leiocarpus bark extract, algae extract, soluble collagen, silica, 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 (Linumusitatissium) seed extract, sodium dehydroacetate, caprylyl glycol, hexyl cinnamal, benzyl salicylate, butylphenyl methylpropional, alpha-isomethylionone, linalool, titanium dioxide, iron oxides.

flormar REBORN FOUNDATION CREAM SUNSCREEN BROAD SPECTRUM SPF 20 SF04 Rich Beige 30ml (

61722-201-00)

INGREDIENTS AND APPEARANCE

FLORMAR REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF04 RICH BEIGE 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61722-201
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)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
UREA (UNII: 8W8T17847W)
ANOGEISSUS LEIOCARPUS BARK (UNII: U5TP1X38RH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LAURETH-12 (UNII: OAH19558U1)
TREHALOSE (UNII: B8WCK70T7I)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COTTON SEED (UNII: DI0ZRJ0MXN)
FLAX SEED (UNII: 4110YT348C)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.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: 61722-201-00	1 in 1 BOX	07/04/2014
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	07/04/2014

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

Establishment
Name	Address	ID/FEI	Business Operations
Kosan Kozmetik Sanayi ve Ticaret A.S.		644090409	manufacture(61722-201)