BARE PERFECTING MAKEUP MERLE NORMAN- octinoxate and titanium dioxide emulsion 
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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Bare Perfecting Makeup Broad Spectrum SPF 25

Active Ingredients purpose
Octinoxate 7.5% Sunscreen
Titanium Dioxide 7.1% 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

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
· 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
Water (Aqua), Cyclopenta siloxane, Clyclohexasiloxane, Isododecane, Alcohol Denat., Cetyl PEG/PPG-10/1 Dimethicone, C12-15 Alkyl Benzoate, Acrylates/Dimethicone Copolymer, Silica, Acrylates Copolymer, Sodium Myristoyl Glutamate, Sorbitan Sesquioleate, Polyhydroxystearic Acid, Disteardimonium Hectorite, Caprylyl Glycol, Aluminum Oxide, Stearic Acid, Propylene Glycol, Propylene Carbonate, Tetrasodium EDTA, Methylisothiazolinone,
May Contain: Iron Oxides, Titanium Dioxide, Triethoxycaprylylsilane

image of carton artimage of bottle art

Perfecting Makeup Broad Spectrum SPF 25
Merle Norman

Established in Los Angeles since 1931
30 mL 1 Fl. Oz.

BARE PERFECTING MAKEUP  MERLE NORMAN
octinoxate, titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57627-123
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE2.25 g  in 30 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE2.13 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
ISODODECANE 
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) 
ALKYL (C12-15) BENZOATE 
SILICON DIOXIDE 
SODIUM MYRISTOYL GLUTAMATE 
SORBITAN SESQUIOLEATE 
POLYHYDROXYSTEARIC ACID (2300 MW) 
CAPRYLYL GLYCOL 
ALUMINUM OXIDE 
STEARIC ACID 
PROPYLENE GLYCOL 
PROPYLENE CARBONATE 
EDETATE SODIUM 
METHYLISOTHIAZOLINONE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
TRIETHOXYCAPRYLYLSILANE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-123-021 in 1 CARTON
1NDC:57627-123-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/22/2012
Labeler - Merle Norman Cosmetics, Inc (008479388)
Registrant - Merle Norman Cosmetics, Inc (008479388)
Establishment
NameAddressID/FEIBusiness Operations
Merle Norman Cosmetics, Inc008479388manufacture(57627-123)

Revised: 6/2013
Document Id: 5cdb287d-e922-466a-b7ed-8d8c8868613a
Set id: 0a506f55-ea6c-44d3-bab2-0a5875c43757
Version: 2
Effective Time: 20130603
 
Merle Norman Cosmetics, Inc