FLORMAR REBORN DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10 - octinoxate cream 
Kosan Kozmetik Sanayi ve Ticaret A.S.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

flormar REBORN DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10

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)

Highlighter Inner Label 1Highlighter Inner Label 2Highlighter Outer Label

FLORMAR REBORN DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61722-023
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
ISODODECANE 
MICA 
BUTYLENE GLYCOL 
DIMETHICONE 
GLYCERIN 
PHENOXYETHANOL 
DISTEARDIMONIUM HECTORITE 
HEXYL LAURATE 
POLYGLYCERYL-4 ISOSTEARATE 
SODIUM CHLORIDE 
TRIETHOXYCAPRYLYLSILANE 
PROPYLENE CARBONATE 
ETHYLHEXYLGLYCERIN 
EDETATE DISODIUM 
LAURETH-12 
CHLORPHENESIN 
PROPYLENE GLYCOL 
GREEN TEA LEAF 
ILEX PARAGUARIENSIS LEAF 
PAULLINIA CUPANA SEED 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61722-023-001 in 1 BOX
130 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/16/2014
Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)
Establishment
NameAddressID/FEIBusiness Operations
Kosan Kozmetik Sanayi ve Ticaret A.S.644090409manufacture(61722-023)

Revised: 6/2014
Document Id: 38c31ab0-d2c1-4de3-ac83-1caf136b32a1
Set id: 8c5a456c-7cb9-46aa-bf42-66383a75f3a7
Version: 1
Effective Time: 20140616
 
Kosan Kozmetik Sanayi ve Ticaret A.S.