DEFENSE CREME NORMAL DRY SPF 15 MERLE NORMAN - octinoxate and titanium dioxide cream 
Merle Norman

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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Preventage Firming Defense Creme Normal Dry SPF 15

active ingredients                     purpose

Octinoxate 6.5%                       firm and helps protect the eye area from sun damage

Titanium Dioxide 2.0%              firm and helps protect the eye area from sun damage

an emollient daytime moisturizing cream that helps firm and protect skin from sun damage.

keep out of reach of children.

Dermatologist tested. non- acnegenic. oil free. fragrance- free

avoid contact with eyes. discontinue use if signs of irritation or rash appear and consult your doctor.

apply to cleansed and toned skin prior to sun exposure

Water (aqua), butyloctyl salicylate, diethylhexyl maleate, glycerin, jojoba esters, cyclopentasiloxane, c10-30 cholesterol/ lanosterol esters, phenyl trimethicone, stearic acid, stearyl alcohol, glyceryl polymethacrylate, biosaccharide gum-1, sorbitan stearate, propylene glycol, dimethicone, PEG-100 stearate, polysorbate 60, ppg-20 methyl glucoseether, bisabolol, glycyrrhetinic acid, collagen amino acids , camellia sinensis leaf extract, palmitoyl hydroxypropyltrimonium amylopectin/ glycerin crosspolymer, hydrolyzed elastin, hyaluronic acid, cetearyl methicone, retinyl palmitate, calluna vulgaris flower extract, hamamelis virginiana ( witch hazel) bark/ leaf/ twig extract, ruscus aculeatus root extract, tocopheryl acetate , ascorbyl pamitate, phospholipids, butylene  glycol, euphrasia officinalis extract, palmitoyl oligopeptide, dimethicone/ vinyl dimethicone crosspolymer, polyquaternium-24, aluminum hydroxide (cl 77002), triethanolamine, PEG-8, PEG-7M, lecithin, carbomer, diazolidinyl urea, phenoxyethanol, trisodium edta





image of secondary label

preventage

firming defense creme

normal/ dry SPF 15

Merle Norman


56g E NET WT. 2 OZ





image of primary label

DEFENSE CREME NORMAL DRY SPF 15  MERLE NORMAN
octinoxate,titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57627-105
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE6.5 g  in 100 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE2.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLOCTYL SALICYLATE 
DIETHYLHEXYL MALEATE 
GLYCERIN 
CYCLOMETHICONE 5 
PHENYL TRIMETHICONE 
STEARIC ACID 
STEARYL ALCOHOL 
BIOSACCHARIDE GUM-1 
SORBITAN MONOSTEARATE 
PROPYLENE GLYCOL 
DIMETHICONE 
PEG-100 STEARATE 
POLYSORBATE 60 
LEVOMENOL 
ENOXOLONE 
GREEN TEA LEAF 
HYALURONIC ACID 
VITAMIN A PALMITATE 
CALLUNA VULGARIS FLOWERING TOP 
HAMAMELIS VIRGINIANA TOP 
ASCORBYL PALMITATE 
BUTYLENE GLYCOL 
PALMITOYL OLIGOPEPTIDE 
ALUMINUM HYDROXIDE 
TROLAMINE 
POLYETHYLENE GLYCOL 400 
DIAZOLIDINYL UREA 
PHENOXYETHANOL 
EDETATE TRISODIUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-105-021 in 1 BOX
1NDC:57627-105-0156 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/20/2011
Labeler - Merle Norman (008479388)
Registrant - Merle Norman (008479388)
Establishment
NameAddressID/FEIBusiness Operations
Merle Norman008479388manufacture

Revised: 1/2012
 
Merle Norman