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Name:Normal Oily Spf 15merle Norman
Manufacturer:Merle Norman
Category:Over-the-counter (OTC) Marketed Drugs


Preventage Firming Defense Creme Normal Oily SPF 15

NORMAL OILY 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 Oily 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

a lightweight cream that helps firm and protect skin from sun damage, pollution and dehydration

keep out of reach of children

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

for external use only. not to be swallowed. 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) , butylene glycol, octyldodecyl neopentanoate, hamamelis virginiana ( witch hazel)  water, myristyl lactate, cyclopentasiloxane, stearic acid, stearyl alcohol, glyceryl polymethacrylate, cyclohexasiloxane , sorbitan stearate, dimethicone, PEG-100 stearate, phenyl trimethicone, ppg-20 methyl glucose ether, palmitoyl hydroxypropyltrimonium amylopectin/ glycerin crosspolymer, polysorbate 60. hydrolyzed elastin, bisabolol, camellia sinensis leaf extract , palmitoyl oligopeptide, hyaluronic acid, glycyrrhetinic acid, retinyl palmitate, Echinacea angustifolia extract, collagen amino acids, calluna vulgaris flower extract, cucumis sativus ( cucumber) fruit extact, ruscus aculeatus root extract, ginkgo biloba leaf extract, lecithin, tocopheryl acetate, ascorbyl palmitate, aluminum hydroxide (Cl 77002), triethanolamine, propylene glycol, polyquaternium -25, biosaccharide gum-1, euphrasia officinalis extract, phospholipids , peg-7m, peg-8, carbomer, citric acid, diazolidinyl urea, phenoxyethanol, trisodium EDTA 120408



image of secondary label

preventage firming defense creme

normal/ oily SPF 15


merle norman

56g E NET WT. 2  OZ


image of primary label





NORMAL OILY SPF 15  MERLE NORMAN
octinoxate,titanium dioxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-106
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 6.5 g  in 100 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2.0 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
BUTYLENE GLYCOL  
OCTYLDODECYL NEOPENTANOATE  
MYRISTYL LACTATE  
CYCLOMETHICONE 5  
STEARIC ACID  
STEARYL ALCOHOL  
CYCLOMETHICONE 6  
SORBITAN MONOSTEARATE  
DIMETHICONE  
PEG-100 STEARATE  
PHENYL TRIMETHICONE  
POLYSORBATE 60  
LEVOMENOL  
GREEN TEA LEAF  
PALMITOYL OLIGOPEPTIDE  
HYALURONIC ACID  
ENOXOLONE  
VITAMIN A PALMITATE  
CUCUMBER  
GINKGO  
ASCORBYL PALMITATE  
ALUMINUM HYDROXIDE  
TROLAMINE  
PROPYLENE GLYCOL  
BIOSACCHARIDE GUM-1  
POLYETHYLENE GLYCOL 400  
CITRIC ACID MONOHYDRATE  
DIAZOLIDINYL UREA  
PHENOXYETHANOL  
EDETATE TRISODIUM  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57627-106-02 1 JAR ( JAR) in 1 BOX contains a JAR (57627-106-01)
1 NDC:57627-106-01 56 g in 1 JAR This package is contained within the BOX (57627-106-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/21/2011

Labeler - Merle Norman (008479388)
Registrant - Merle Norman (008479388)
Establishment
Name Address ID/FEI Operations
Merle Norman 008479388 manufacture

Revised: 04/2011 Merle Norman



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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