FOUNDATION PRIMER SPF 15- titanium dioxide , zinc oxide , octinoxate cream

Foundation Primer SPF 15 by

Drug Labeling and Warnings

Foundation Primer SPF 15 by is a Otc medication manufactured, distributed, or labeled by Mary Kay Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: ZINC OXIDE (19.5% W/W), OCTINOXATE(5% W/W) , TITANIUM DIOXIDE (1.5% W/W)

WARNINGS

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.

INDICATIONS & USAGE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOUNDATION PRIMER SPF 15 
titanium dioxide , zinc oxide , octinoxate cream

Product 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)