MARY KAY FOUNDATION PRIMER- avobenzone, homosalate, octisalate and octocrylene gel 
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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Mary Kay Foundation Primer SPF 15
Drug Facts

Active Ingredients

Avobenzone 2.5%

Homosalate 9%

Octisalate 5%

Octocrylene 3%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

isododecane, dimethicone/bis-isobutyl PPG-20 crosspolymer, polysilicone-11, vp/hexadecene copolymer, silica, C12-15 alkyl benzoate, polyester-7, neopentyl glycol diheptanoate, tribehenin, dipropylene glycol dibenzoate, PPG-15 stearyl ether benzoate

Other information

protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-627-9529

Principal Display Panel - 29 mL carton

Mary Kay

foundation primer

sunscreen

broad spectrum

spf 15

1 FL. OZ. / 29 mL

Image of carton

MARY KAY FOUNDATION PRIMER 
avobenzone, homosalate, octisalate, octocrylene gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51531-0850
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
ISODODECANE (UNII: A8289P68Y2)  
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
POLYESTER-7 (UNII: 0841698D2F)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51531-0850-1 1 in 1 CARTON
1 29 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 03/01/2012
Labeler - Mary Kay Inc. (103978839)
Establishment
Name Address ID/FEI Business Operations
Mary Kay Inc. 103978839 manufacture(51531-0850)

Revised: 3/2013
Document Id: acca6d11-87a8-4963-aa33-2fc9a99c3869
Set id: 59d25b44-1adb-4790-8ce6-2d847a06b8b3
Version: 1
Effective Time: 20130315
 
Mary Kay Inc.