FOUNDATION PRIMER SPF 15 - titanium dioxide , zinc oxide , octinoxate  cream 
Mary Kay 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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ACTIVE INGREDIENTS: ZINC OXIDE (19.5% W/W), OCTINOXATE(5% W/W) , TITANIUM DIOXIDE (1.5% W/W)


Warnings; Contains OXYBENZONE. For external use only. Not to be swallowed. Avoid contact with the eyes. Discontinue use if signs of irritation or rash appear.




Directions; In the morning , after applying Essence , apply Day Moisturizer With SPF 15 liberally over face and neck.


Image of Carton

FOUNDATION PRIMER SPF 15 
titanium dioxide , zinc oxide , octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51531-4189
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.222 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.73 g  in 14 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.7 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51531-4189-014 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/11/2009
Labeler - Mary Kay Inc. (103978839)

Revised: 3/2011
Document Id: 6769f6f0-8310-440c-aceb-e11f97d7790d
Set id: fb80ae70-b627-4f98-acf5-488a33f6c7f8
Version: 1
Effective Time: 20110308
 
Mary Kay Inc.