FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN- octinoxate and octisalate cream 
Merle Norman Cosmetics, 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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Merle Norman Foundation Primer Plus SPF 15

Active ingredients purpose

OCTINOXATE 7.5% Sunscreen

OCTISALATE 5.0% Sunscreen

Uses Helps Prevent sunburn

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Stop use and ask a doctor if rash occurs and persists.

WARNINGS
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
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.

Directions
For Sunscreen use

· Apply liberally 15 minutes before sun exposure
· Use a water resistant sunscreen if swimming or sweating

· Reapply at least every 2 hours
· Children under 6 months: Ask a doctor

Cyclopentasiloxane, dimethicone crosspolymer, trisiloxane, dimethicone/ vinyl dimethicone crosspolymer, cyclomethicone , palmitoyl oligopeptide, ascorbyl palmitate, retinyl palmitate, tocopheryl acetate, ceramide 2, camellia oleifera leaf extract, peg-10 rapeseed sterol, phospholipids , C12-15 alkyl benzoate, cyclotetrasiloxane, water (aqua), isoceteth-10, tribehenin, butylene glycol, silica, phenoxyethanol

image of primary labelimage of secondary label

Foundation Primer Plus


SPF 15
Merle Norman

35g E NET WT. 1.25 OZ.

FOUNDATION PRIMER PLUS SPF 15  MERLE NORMAN
octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57627-108
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE2.63 g  in 35 g
OCTISALATE (OCTISALATE) OCTISALATE1.75 g  in 35 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 
TRISILOXANE 
CYCLOMETHICONE 6 
PALMITOYL OLIGOPEPTIDE 
ASCORBYL PALMITATE 
VITAMIN A PALMITATE 
CERAMIDE 2 
CAMELLIA OLEIFERA LEAF 
PEG-10 RAPESEED STEROL 
ALKYL (C12-15) BENZOATE 
TRIBEHENIN 
BUTYLENE GLYCOL 
SILICON DIOXIDE 
PHENOXYETHANOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-108-021 in 1 BOX
1NDC:57627-108-0135 g in 1 TUBE
2NDC:57627-108-035 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/22/2011
Labeler - Merle Norman Cosmetics, Inc (008479388)
Registrant - Merle Norman Cosmetics, Inc (008479388)
Establishment
NameAddressID/FEIBusiness Operations
Merle Norman Cosmetics, Inc 008479388manufacture(57627-108)

Revised: 5/2013
Document Id: 6436ffc8-f5ac-4333-a4f8-80160ed242c5
Set id: 582ce0b2-addc-4b87-9334-c8f515b10a16
Version: 7
Effective Time: 20130524
 
Merle Norman Cosmetics, Inc