Label: KEEP THE PEACE PROTECT AND CORRECT- titanium dioxide and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 50184-6600-1 - 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 24, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
CYCLOPENTASILOXANE, DIMETHICONE CROSSPOLYMER, C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, BEHENOXY DIMETHICONE, PHYTOSTEROLS, TOCOTRIENOLS, TOCOPHEROL, ORYZA SATIVA (RICE) BRAN WAX, SQUALENE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, GLYCINE SOJA (SOYBEAN) STEROLS, DIMETHICONE, CETEARYL METHICONE, LINOLEIC ACID, PHOSPHOLIPIDS, POLYHYDROXYSTEARIC ACID, BISABOLOL, CAPYLYL GLYCOL, SIMETHICONE, ALUMINA, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, IRON OXIDES (CI 77491, 77492, 77499).
- PURPOSE
- WARNINGS
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KEEP THE PEACE PROTECT AND CORRECT
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50184-6600 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.88 mL in 60 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE 1.8 mL in 60 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) RICE BRAN (UNII: R60QEP13IC) SQUALENE (UNII: 7QWM220FJH) ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8) SOYBEAN (UNII: L7HT8F1ZOD) DIMETHICONE (UNII: 92RU3N3Y1O) LINOLEIC ACID (UNII: 9KJL21T0QJ) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) LEVOMENOL (UNII: 24WE03BX2T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALUMINUM OXIDE (UNII: LMI26O6933) PHENOXYETHANOL (UNII: HIE492ZZ3T) OCTYLTRIETHOXYSILANE (UNII: LDC331P08E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50184-6600-1 60 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/24/2011 Labeler - Philosophy, Inc. (948102256) Establishment Name Address ID/FEI Business Operations Philosophy Inc for BioTech Research Labs 948102256 manufacture