FLORMAR RADIANT PINK SKIN HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octinoxate, octocrylene cream

FLORMAR RADIANT PINK SKIN HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

FLORMAR RADIANT PINK SKIN HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 15 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

Avobenzone 3%

Octinoxate 7.5%

Octocrylene 1%

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 alone or as a thin layer under foundation.
• 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
  

SPL UNCLASSIFIED SECTION

Inactive ingredients

WATER,CYCLOPENTASILOXANE, BUTYLENE GLYCOL, SYNTHETIC FLUORPHLOGOPITE, ISOCETYL STEAROYL STEARATE, CETEARYL OLIVATE,
DIMETHICONE, CETEARYL ALCOHOL, SORBITAN OLIVATE, POLYGLYCERYL-3 POLYDIMETHYL SILOXYETHYL DIMETHICONE, PHENOXYETHANOL, PANTHENOL, STEARIC ACID, SACCHARIDE ISOMERATE, FRAGRANCE, SILICA, PHENYLPROPANOL, CAPRYLYL GLYCOL, PROPANEDIOL, ETHYLHEXYLGLYCERIN, TIN OXIDE, CITRIC ACID, SODIUM CITRATE, TRIETHOXYCAPRYLYLSILANE, TOCOPHEROL, TITANIUM DIOXIDE, IRON OXIDES.

Peel away for Drug Facts

This soft formula with a blend of unique pink pearls helps dull skin appear brighter for a perfect look.  Apply alone or as a thin layer under foundation.  Kosan Kozmetik Sanayi 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  To report a serious adverse event contact [971] 766-7350

PRINCIPAL DISPLAY PANEL

Flormar  RADIANT PINK SKIN HIGHLIGHTER SUNSCREEN CREAM BROAD SPECTRUM SPF 15  0.61 FL oz (18 ml)

Product Label

INGREDIENTS AND APPEARANCE

FLORMAR RADIANT PINK SKIN HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 15 
avobenzone, octinoxate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61722-220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SORBITAN OLIVATE (UNII: MDL271E3GR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PANTHENOL (UNII: WV9CM0O67Z)
STEARIC ACID (UNII: 4ELV7Z65AP)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYLPROPANOL (UNII: 0F897O3O4M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PROPANEDIOL (UNII: 5965N8W85T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
STANNIC OXIDE (UNII: KM7N50LOS6)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61722-220-00	1 in 1 CARTON	11/07/2014
1		18 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	11/07/2014

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