SUPERNATURAL PORELESS FLAWLESS TINTED SPF 15 - octisalate and titanium dioxide cream 
Philosophy, 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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Drug Facts

Active ingredients

Octisalate 5% w/w

Titanium Dioxide 4% w/w

Cyclopentasiloxane   74.863% w/w

Dimethicone Crosspolymer    6.25% w/w

Dimethicone Vinyl Dimethicone crosspolymer   5.309% w/w

Grossypium Herbaceum Cotton   1.48% w/w

Phytosterols   0.037% w/w

Tocotrienols   0.0160% w/w

Tocopherol    0.0170% w/w

Squalene   0.0150% w/w

Oryza Sativa (Rice) Bran Wax   0.0150% w/w

Retinyl Palmitate   0.100% w/w

Simethicone   0.0025% w/w

Alumina   0.0025% w/w

Dimethicone   0.2400% w/w

Silica   0.400% w/w

Squalane   0.200% w/w

Fragrance   0.1000% w/w

Triethoxycaprylylsilane   0.0045% w/w

Phenoxyethanol   0.2750% w/w

Caprylyl Glycol   0.2250% w/w

Iron Oxides   0.4485% w/w


STOP USE AND ASK DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS

WARNINGS: FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT:

KEEP OUT OF EYES.  RINSE WITH WATER TO REMOVE.

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CENTER RIGHT AWAY.

INDICATIONS:

HELPS PREVENT SUNBURN

HIGHER SPF GIVES MORE SUNBURN PROTECTION

INDICATIONS:

HELPS PREVENT SUNBURN

HIGHER SPF GIVES MORE SUNBURN PROTECTION



DIRECTIONS: APPLY EVENLY OVER ENTIRE FACE AS A FOUNDATION OR PRIMER OR ALONE.  APPLY LIBERALLY BEFORE SUN EXPOSURE AND AS NEEDED.

image of box

SUPERNATURAL PORELESS FLAWLESS TINTED SPF 15 
octisalate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-3800
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide40 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Levant Cotton Oil (UNII: N5CFT140R8)  
.Beta.-Sitosterol (UNII: S347WMO6M4)  
Alpha-Tocopherol (UNII: H4N855PNZ1)  
Squalene (UNII: 7QWM220FJH)  
Rice Germ Oil (UNII: D4H5GGS5JF)  
Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
Aluminum Oxide (UNII: LMI26O6933)  
Dimethicone (UNII: 92RU3N3Y1O)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Squalane (UNII: GW89575KF9)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50184-3800-21 in 1 CARTON12/01/2009
1NDC:50184-3800-145.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/2009
Labeler - Philosophy, Inc. (948102256)
Establishment
NameAddressID/FEIBusiness Operations
Process Technologies and Packaging Inc.809172885manufacture(50184-3800)

Revised: 1/2010
Document Id: b189b6ba-6d2b-4142-8ba2-2719dd5607a6
Set id: 146925bc-3619-45bc-9f49-d83f805d27e7
Version: 3
Effective Time: 20100129
 
Philosophy, Inc.