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

Foundation Primer Plus SPF 15 by

Drug Labeling and Warnings

Foundation Primer Plus SPF 15 by is a Otc medication manufactured, distributed, or labeled by Merle Norman Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients   Purpose

OCTINOXATE 7.5%  sunscreen

OCTISALATE 5.0%   sunscreen

PURPOSE

Uses Helps Prevent Sunburn

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs and persists

WARNINGS

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

Foundation Primer Plus

SPF 15

Merle Norman

35g Net Wt. 1.25 OZ

INGREDIENTS AND APPEARANCE

FOUNDATION PRIMER PLUS SPF 15   MERLE NORMAN
octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.63 g  in 35 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.75 g  in 35 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-108-02	1 in 1 BOX	04/22/2011
1	NDC: 57627-108-01	35 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 57627-108-04	1 in 1 BOX	04/22/2011
2	NDC: 57627-108-03	5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/22/2011

Labeler - Merle Norman Cosmetics (008479388)

Registrant - Merle Norman Cosmetics (008479388)

Establishment
Name	Address	ID/FEI	Business Operations
Merle Norman Cosmetics		008479388	manufacture(57627-108)