VIRTUAL MATTE  OIL CONTROL MAKEUP BROAD SPECTRUM SPF 15- octinoxate and titanium dioxide liquid 
PRESCRIPTIVES INC

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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VIRTUAL MATTE
OIL CONTROL MAKEUP BROAD SPECTRUM SPF 15

Drug Facts

Active ingredients

Octinoxate 2.50%
Titanium Dioxide 0.97%

Purpose

Sunscreen

Use

helps prevent sunburn

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.

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every two 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

Inactive ingredients

water\aqua\eau • cyclopentasiloxane • butylene glycol • peg-10 dimethicone • trimethylsiloxysilicate • dimethicone • magnesium sulfate • dimethicone/peg-10/15 crosspolymer • laminaria saccharina extract • algae extract • acetyl hexapeptide-8 • sodium hyaluronate • cholesterol • ceramide 2 • linoleic acid • tocopheryl • acetate • hydrogenated lecithin • sorbitan sesquioleate • polysilicone-11 • phenyl trimethicone • lecithin • peg/ppg-18/ 18 dimethicone • disteardimonium hectorite • triethoxycaprylylsilane • propylene carbonate • silica • dimethicone/peg-10 crosspolymer • xanthan gum • laureth-7 • methyl methacrylate crosspolymer • methoxy amodimethicone/ silsesquioxane copolymer • dipropylene glycol • bht • chloroxylenol • phenoxyethanol • methylparaben • propylparaben • [+/- mica • iron oxides (ci 77491, ci 77492, ci 77499) • titanium dioxide (ci 77891)] <ILN37462>

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

PRESCRIPTIVES

Virtual Matte

Oil-Control Makeup

Broad Spectrum SPF 15

1 FL. OZ./OZ. LIQ./30 ml e

Principal Display Panel - 30 mL Bottle Carton
VIRTUAL MATTE   OIL CONTROL MAKEUP BROAD SPECTRUM SPF 15
octinoxate and titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59158-915
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.02775 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.010767 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
butylene glycol (UNII: 3XUS85K0RA)  
dimethicone (UNII: 92RU3N3Y1O)  
magnesium sulfate (UNII: DE08037SAB)  
saccharina latissima (UNII: 68CMP2MB55)  
acetyl hexapeptide-8 (UNII: L4EL31FWIL)  
hyaluronate sodium (UNII: YSE9PPT4TH)  
cholesterol (UNII: 97C5T2UQ7J)  
ceramide 2 (UNII: C04977SRJ5)  
linoleic acid (UNII: 9KJL21T0QJ)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
sorbitan sesquioleate (UNII: 0W8RRI5W5A)  
phenyl trimethicone (UNII: DR0K5NOJ4R)  
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
disteardimonium hectorite (UNII: X687XDK09L)  
triethoxycaprylylsilane (UNII: LDC331P08E)  
propylene carbonate (UNII: 8D08K3S51E)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
xanthan gum (UNII: TTV12P4NEE)  
laureth-7 (UNII: Z95S6G8201)  
dipropylene glycol (UNII: E107L85C40)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
chloroxylenol (UNII: 0F32U78V2Q)  
phenoxyethanol (UNII: HIE492ZZ3T)  
methylparaben (UNII: A2I8C7HI9T)  
propylparaben (UNII: Z8IX2SC1OH)  
mica (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59158-915-011 in 1 CARTON
130 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/2003
Labeler - PRESCRIPTIVES INC (151701588)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(59158-915) , REPACK(59158-915)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(59158-915) , RELABEL(59158-915) , REPACK(59158-915)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(59158-915) , RELABEL(59158-915)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(59158-915)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(59158-915)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(59158-915)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(59158-915)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE943871157MANUFACTURE(59158-915) , RELABEL(59158-915) , REPACK(59158-915)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL959338336MANUFACTURE(59158-915) , RELABEL(59158-915) , REPACK(59158-915)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774MANUFACTURE(59158-915) , RELABEL(59158-915) , REPACK(59158-915)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(59158-915)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(59158-915)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center078364654RELABEL(59158-915) , REPACK(59158-915)

Revised: 6/2013
Document Id: 51a85dfa-3a72-43c4-8d2d-a01542b2999c
Set id: 7ca37428-978e-4312-8564-a6ace5fb4dcd
Version: 1
Effective Time: 20130618
 
PRESCRIPTIVES INC