Your browser does not support JavaScript! MARY KAY FOUNDATION PRIMER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [MARY KAY INC.]
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MARY KAY FOUNDATION PRIMER (avobenzone, homosalate, octisalate, octocrylene) gel
[Mary Kay Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

Active Ingredients

Avobenzone 2.5%

Homosalate 9%

Octisalate 5%

Octocrylene 3%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

  • apply liberally 15 minutes before sun exposure
  • use a water-resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51531-0850
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE2.5 g  in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE9 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISODODECANE 
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) 
SILICON DIOXIDE 
ALKYL (C12-15) BENZOATE 
POLYESTER-7 
NEOPENTYL GLYCOL DIHEPTANOATE 
TRIBEHENIN 
DIPROPYLENE GLYCOL DIBENZOATE 
PPG-15 STEARYL ETHER BENZOATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51531-0850-11 in 1 CARTON
129 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/2012
Labeler - Mary Kay Inc. (103978839)
Establishment
NameAddressID/FEIBusiness Operations
Mary Kay Inc.103978839manufacture(51531-0850)

Revised: 3/2013
 
Mary Kay Inc.

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