FLORMAR REBORN DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10- octinoxate cream

flormar REBORN DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10 by

Drug Labeling and Warnings

flormar REBORN DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10 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 DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10

Active ingredient

Octinoxate 5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
  

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
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

• Use all over face or to enlighten your chest area or shoulders.
• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• 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, isododecane, mica, butylene glycol, dimethicone, PEG-10 dimethicone, trimethylsiloxysilicate, polymethylsilsesquioxane, glycerin, phenoxyethanol, polysilicone-11, disteardimonium hectorite, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, polyglyceryl-4 isostearate, sodium chloride, triethoxycaprylylsilane, propylene carbonate, ethylhexylglycerin, algae extract, disodium EDTA, fragrance, laureth-12, chlorphenesin, propylene glycol, tea (Camellia sinensis) leaf extract, maté (Ilex paraguariensis) leaf extract, guarana (Paullinia cupana) seed extract, sodium dexydroacetate, titanium dioxide, iron oxides.

flormar REBORN DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10 30ml (

61722-023-00)

INGREDIENTS AND APPEARANCE

FLORMAR REBORN DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61722-023
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)
ISODODECANE (UNII: A8289P68Y2)
MICA (UNII: V8A1AW0880)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LAURETH-12 (UNII: OAH19558U1)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
PAULLINIA CUPANA SEED (UNII: C21GE7524R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61722-023-00	1 in 1 BOX	06/16/2014
1		30 mL in 1 JAR; 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	06/16/2014

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