FLORMAR PRETTY IDEAL BALANCE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 P101 PORCELAIN - 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 PRETTY Ideal Balance Foundation Cream Sunscreen Broad Spectrum SPF 15 P101 Porcelain

flormar PRETTY Ideal Balance Foundation Cream Sunscreen Broad Spectrum SPF 15 P101 Porcelain 35ml (61722-100-00)


Active Ingredient

Octinoxate 2.8%

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

Dimethicone, Water, butylene glycol, peg-10 dimethicone, polymethylsilsesquioxane, betaine, disteardimonium hectorite, trimethylsiloxysilicate, sd alcohol 40-b, phenoxyethanol, dimethicone/vinyl dimethicone crosspolymer, glycerin, prunus armeniaca (apricot) kernel oil, panthenol, sodium chloride, aluminum hydroxide, triethoxycaprylysilane, fragrance, ethylhexylglycerin, matricaria (chamomilla recutita) flower extract, strawberry (fragaria ananassa) fruit extract, pomegranate (punica granatum) fruit extract, hexly cinnamal, benzyl salicylate, butylphenyl methylpropional, alpha-isomethyl ionone, titanium dioxide, iron oxides

flormar PRETTY Ideal Balance Foundation Cream Sunscreen Broad Spectrum SPF 15 P101 Porcelain 35ml (61722-100-00)

Pretty Ideal

FLORMAR PRETTY IDEAL BALANCE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 P101 PORCELAIN 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61722-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE28 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE 
WATER 
BUTYLENE GLYCOL 
BETAINE 
DISTEARDIMONIUM HECTORITE 
PHENOXYETHANOL 
GLYCERIN 
APRICOT KERNEL OIL 
PANTHENOL 
SODIUM CHLORIDE 
ALUMINUM HYDROXIDE 
ETHYLHEXYLGLYCERIN 
.ALPHA.-HEXYLCINNAMALDEHYDE 
BENZYL SALICYLATE 
BUTYLPHENYL METHYLPROPIONAL 
ISOMETHYL-.ALPHA.-IONONE 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61722-100-001 in 1 BOX
135 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/07/201407/16/2017
Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)
Establishment
NameAddressID/FEIBusiness Operations
Kosan Kozmetik Sanayi ve Ticaret A.S.644090409manufacture(61722-100)

Revised: 7/2014
Document Id: 15f742b9-63eb-4048-8c77-0c8aeb33181e
Set id: ba9a6cc3-7e05-463d-993f-a4f14f3811ba
Version: 3
Effective Time: 20140717
 
Kosan Kozmetik Sanayi ve Ticaret A.S.