Creamy Beige Perfecting Makeup Broad Spectrum SPF 25 Merle Norman

Dosage form: emulsion
Ingredients: OCTINOXATE 2.25g in 30mL, TITANIUM DIOXIDE 2.13g in 30mL
Labeler: Merle Norman Cosmetics, Inc
NDC Code: 57627-128

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.

Creamy Beige Perfecting Makeup 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

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
· 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

Perfecting Makeup Broad Spectrum SPF 25
Merle Norman Established in Los Angeles since 1931
30 mL 1 Fl. Oz.

CREAMY BEIGE PERFECTING MAKEUP BROAD SPECTRUM SPF 25  MERLE NORMAN
octinoxate, titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-128
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
WATER 
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
ISODODECANE 
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) 
ALKYL (C12-15) BENZOATE 
SILICON DIOXIDE 
DISODIUM MYRISTOYL GLUTAMATE 
SORBITAN SESQUIOLEATE 
POLYHYDROXYSTEARIC ACID (2300 MW) 
CAPRYLYL GLYCOL 
ALUMINUM OXIDE 
STEARIC ACID 
PROPYLENE GLYCOL 
PROPYLENE CARBONATE 
EDETATE DISODIUM 
METHYLISOTHIAZOLINONE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
TRIETHOXYCAPRYLYLSILANE 
Packaging
#Item CodePackage Description
1NDC:57627-128-021 BOTTLE in 1 CARTON
1NDC:57627-128-0130 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/FEIOperations
Merle Norman Cosmetics, Inc008479388manufacture(57627-128)

Revised: 02/2014
 
Merle Norman Cosmetics, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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