SUPERNATURAL PORELESS FLAWLESS TINTED SPF 15- octisalate and titanium dioxide cream

Supernatural Poreless Flawless Tinted SPF 15 by

Drug Labeling and Warnings

Supernatural Poreless Flawless Tinted SPF 15 by is a Otc medication manufactured, distributed, or labeled by Philosophy, Inc., Process Technologies and Packaging Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Octisalate 5% w/w

Titanium Dioxide 4% w/w

INACTIVE INGREDIENT

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

ASK DOCTOR

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

GENERAL PRECAUTIONS

WARNINGS: FOR EXTERNAL USE ONLY

WHEN USING

WHEN USING THIS PRODUCT:

KEEP OUT OF EYES.  RINSE WITH WATER TO REMOVE.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

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

PURPOSE

INDICATIONS:

HELPS PREVENT SUNBURN

HIGHER SPF GIVES MORE SUNBURN PROTECTION

INDICATIONS & USAGE

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUPERNATURAL PORELESS FLAWLESS TINTED SPF 15 
octisalate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50184-3800
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	40 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50184-3800-2	1 in 1 CARTON	12/01/2009
1	NDC: 50184-3800-1	45.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/01/2009

Labeler - Philosophy, Inc. (948102256)

Establishment
Name	Address	ID/FEI	Business Operations
Process Technologies and Packaging Inc.		809172885	manufacture(50184-3800)