Label: SUPERNATURAL PORELESS FLAWLESS TINTED SPF 15- octisalate and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 50184-3800-1, 50184-3800-2 - Packager: Philosophy, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 29, 2010
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
- GENERAL PRECAUTIONS
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUPERNATURAL PORELESS FLAWLESS TINTED SPF 15
octisalate and titanium dioxide creamProduct 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)
