Label: FOUNDATION PRIMER SPF 15- titanium dioxide , zinc oxide , octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51531-4189-0 - Packager: Mary Kay 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 March 8, 2011
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- ACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
FOUNDATION PRIMER SPF 15
titanium dioxide , zinc oxide , octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51531-4189 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.222 g in 14 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.73 g in 14 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.7 g in 14 g Inactive Ingredients Ingredient Name Strength ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Tribehenin (UNII: 8OC9U7TQZ0) CERESIN (UNII: Q1LS2UJO3A) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Methylparaben (UNII: A2I8C7HI9T) Dimethicone (UNII: 92RU3N3Y1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) FRUIT (UNII: C2AIY4ERZC) FERULA ASSA-FOETIDA ROOT (UNII: 3U9288P88T) SUNFLOWER SEED (UNII: R9N3379M4Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51531-4189-0 14 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/11/2009 Labeler - Mary Kay Inc. (103978839)