DUAL SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion 
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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AVOBENZONE   3.0%

HOMOSALATE   8.0%

OCTISALATE   4.0%

OCTOCRYLENE 2.35%

OXYBENZONE   5.0%

A lightweight formula that blends on easily and absorbs quickly while providing broad UVA/ UVB sunscreen protection.

Keep out of reach of children

for external use only. not to be swallowed .

avoid contact with eyes. discontinue use and ask doctor if signs of irritation appear. if swallowed get medical help or contact a poison control center immediately . may stain some fabrics

Apply liberally 30 minutes prior to sun exposure. reapply as needed. after swimming or excessive perspiration.

water(aqua) octyldodecyl neopentanoate, butylene glycol, diethyhexyl syringylidenemalonate, polymethyl methacrylate, potassium cetyl phosphate, tocopheryl acetate, retinyl palmitate, ascorbyl palmitate, calicum pantothenate, chamimilla recutita( maricaria) flower extract, acetyl tyrosine, proline, hydrolyzed vegetable protein, adenosine triphosphate, bisabolol, phospholipids, lactic acid, BHT, glucose, cyclopentasilozane, glycerin, PPG-17/IPDI/DMPA copolymer, hydrogenated palm glycerides, glyceryl stearate, PEG-100 Stearate, Acrylates/ C10-30 alkyl acrylate crosspolymer, xanthan gum, caprylic/ capric triglyceride, hexylene glycol , ethoxydiglycol, propylene glycol, triethanolamine, trisodium EDTA, caprylyl glycol, Methylisothiazolinone 112409



image of primary label



Merle Norman

Dual Spectrum

SPF 30

UVA UVB Protection

119g NET WT.4.2 Oz



image of secondary label


DUAL SPECTRUM  SPF 30
avobenzone, homosalate,octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-552
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE3 g  in 100 g
HOMOSALATE (HOMOSALATE) HOMOSALATE8 g  in 100 g
OCTISALATE (OCTISALATE) OCTISALATE4 g  in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE2.35 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
OCTYLDODECYL NEOPENTANOATE 
OCTYLDODECYL NEOPENTANOATE 
BUTYLENE GLYCOL 
VITAMIN A PALMITATE 
ASCORBYL PALMITATE 
CALCIUM PANTOTHENATE 
CHAMOMILE 
PROLINE 
ADENOSINE TRIPHOSPHATE 
BUTYLATED HYDROXYTOLUENE 
CYCLOMETHICONE 5 
GLYCERIN 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
XANTHAN GUM 
HEXYLENE GLYCOL 
DIETHYLENE GLYCOL MONOETHYL ETHER 
PROPYLENE GLYCOL 
TROLAMINE 
EDETATE TRISODIUM 
CAPRYLYL GLYCOL 
Packaging
#Item CodePackage Description
1NDC:57627-552-021 in 1 BOX
1NDC:57627-552-01119 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/16/2011
Labeler - Merle Norman Cosmetics, Inc. (008479388)
Registrant - Merle Norman Cosmetics, Inc. (008479388)
Establishment
NameAddressID/FEIBusiness Operations
Merle Norman Cosmetics, Inc.008479388manufacture

Revised: 01/2012
Document Id: 4a3f652d-1ae5-41fb-a8d8-df5708570dbe
Set id: ac484d04-39f8-4627-9cb0-0a3b551d4564
Version: 7
Effective Time: 20120112
 
Merle Norman Cosmetics, Inc.