CREAMY BEIGE SMART FINISH BROAD SPECTRUM SPF 18 MERLE NORMAN- 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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Creamy Beige Smart Finish Makeup Broad Spectrum SPF 18

Active ingredient Purpose

Titanium Dioxide 17.3 % Sunscreen

Uses
· helps prevent sunburn
· If used as directed with other sun protection measures (see Directions),
decreases the risk of skin cancer and early skin aging caused by the sun

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

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

Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Sun Protection Measures. Spending time in the sun increases your risk of skin
cancer and early skin aging. To decrease this risk, regularly use a sunscreen
with broad spectrum SPF of 15 or higher and other sun protection measures
including:
limit time in the sun, especially from 10 a.m. - 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor


Inactive ingredients: Dimethicone, Isopropyl Isostearate, Silica, Isostearyl Behenate,
Tribehenin, Iron Oxides, Sorbitan Trioleate, Euphorbia Cerifera (Candelilla) Wax,
Neopentyl Gylcol Diethylhexanoate, Myristyl Myristate, Tridecyl Trimellitate, Talc, Nylon-12,
Lauroyl Lysine, Boron Nitride, Polyethylene, Squalane, Tocopheryl Acetate, Trimethylsiloxysilicate,
Barium Sulfate, Hexyl Laurate, Lauryl PEG/PPG-18/18 Methicone, Tetrahexyldecyl Ascorbate,
Cetyl PEG/ PPG-10/1 Dimethicone, Polyglyceryl -4 isostearate, Ethylene/ Methacrylate Copolymer,
Isopropyl Titanium Triisostearate, Neopentyl Glycol Diisostearate, Mica, Phenoxyethanol, BHT.

image of carton backimage of peel off labelimage of carton front

Creamt Beige


Smart Finish
Compact Makeup SPF 18

Merle Norman
13 g NET WT. .45oz

CREAMY BEIGE SMART FINISH BROAD SPECTRUM SPF 18  MERLE NORMAN
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57627-143
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE2.25 g  in 13 g
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE 
SILICON DIOXIDE 
TRIBEHENIN 
FERROUS OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
SORBITAN TRIOLEATE 
CANDELILLA WAX 
NEOPENTYL GLYCOL DIETHYLHEXANOATE 
MYRISTYL MYRISTATE 
TRIDECYL TRIMELLITATE 
TALC 
LAUROYL LYSINE 
BORON NITRIDE 
SQUALANE 
.ALPHA.-TOCOPHEROL ACETATE 
BARIUM SULFATE 
HEXYL LAURATE 
TETRAHEXYLDECYL ASCORBATE 
MICA 
PHENOXYETHANOL 
BUTYLATED HYDROXYTOLUENE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-143-021 in 1 CARTON
1NDC:57627-143-0113 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/03/2011
Labeler - Merle Norman (008479388)
Registrant - Merle Norman (008479388)
Establishment
NameAddressID/FEIBusiness Operations
Merle Norman008479388manufacture(57627-143)

Revised: 9/2012
 
Merle Norman