DOLCE AND GABBANA THE FOUNDATION PERFECT MATTE  BROADSPECTRUM SPF 20 ALL SHADES- ensulizole liquid 
Procter & Gamble Manufacturing Company

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.

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Drug Facts

Active ingredients

Ensulizole 3%

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use 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 sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: ask a doctor

Other information

  • protect this product from excessive heat and direct sun

Inactive ingredients

Water, cyclomethicone, propylene glycol, talc, dimethicone, aluminum starch octenylsuccinate, sodium chloride, PEG/PPG-18/18 dimethicone, PVP, benzyl alcohol, phenoxyethanol, sodium hydroxide, ethylene/methacrylate copolymer, arachidyl behenate, trihydroxystearin, tocopheryl acetate, silica, methicone, sodium benzoate, HDI/trimethylol hexyllactone crosspolymer, synthetic wax, polyglyceryl-4 isostearate, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, isopropyl titanium triisostearate, ethylene brassylate, polyethylene, iron oxides, titanium dioxide

Questions or comments?

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PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

DOLCE & GABBANA

THE FOUNDATION

PERFECT
MATTE LIQUID
FOUNDATION
WITH ENSULIZOLE
SUNSCREEN

BROAD SPECTRUM SPF 20

30 ml / 1 FL. OZ.

Principal Display Panel - 30 ml Bottle Carton
DOLCE AND GABBANA THE FOUNDATION PERFECT MATTE   BROADSPECTRUM SPF 20 ALL SHADES
ensulizole liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-080
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ensulizole (Ensulizole) Ensulizole30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Cyclomethicone 
Propylene Glycol 
Talc 
Dimethicone 
Aluminum Starch Octenylsuccinate 
Sodium Chloride 
PEG/PPG-18/18 Dimethicone 
Benzyl Alcohol 
Phenoxyethanol 
Sodium Hydroxide 
Arachidyl Behenate 
Trihydroxystearin 
.Alpha.-Tocopherol Acetate 
Silicon Dioxide 
Sodium Benzoate 
Polyglyceryl-4 Isostearate 
Hexyl Laurate 
Isopropyl Titanium Triisostearate 
Ethylene Brassylate 
High Density Polyethylene 
Titanium Dioxide 
Packaging
#Item CodePackage Description
1NDC:37000-080-301 in 1 CARTON
130 mL in 1 BOTTLE, PUMP
2NDC:37000-080-1515 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/01/2012
Labeler - Procter & Gamble Manufacturing Company (004238200)
Establishment
NameAddressID/FEIBusiness Operations
P & G K. K.713196116MANUFACTURE(37000-080)

Revised: 10/2012
Document Id: fce199b8-f121-4bb0-bdf8-e0eddee7bbff
Set id: 4294218b-1ac4-41de-8e6f-c1e6df49c9b6
Version: 1
Effective Time: 20121022
 
Procter & Gamble Manufacturing Company