FOUNDATION PRIMER PLUS SPF 15  MERLE NORMAN- octinoxate, octisalate cream 
Merle Norman Cosmetics

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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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 prevent sunburn, not skin canceror 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

Inactive ingredients

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.

Foundation Primer Plus

SPF 15

Merle Norman

35g Net Wt. 1.25 OZ

carton

tube

FOUNDATION PRIMER PLUS SPF 15   MERLE NORMAN
octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.63 g  in 35 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.75 g  in 35 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
CERAMIDE 2 (UNII: C04977SRJ5)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-108-021 in 1 BOX04/22/2011
1NDC:57627-108-0135 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:57627-108-041 in 1 BOX04/22/2011
2NDC:57627-108-035 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/22/2011
Labeler - Merle Norman Cosmetics (008479388)
Registrant - Merle Norman Cosmetics (008479388)
Establishment
NameAddressID/FEIBusiness Operations
Merle Norman Cosmetics008479388manufacture(57627-108)

Revised: 10/2022
Document Id: eb7c34f9-a3f9-3858-e053-2995a90aef89
Set id: 582ce0b2-addc-4b87-9334-c8f515b10a16
Version: 15
Effective Time: 20221020
 
Merle Norman Cosmetics