BARE PERFECTING MAKEUP MERLE NORMAN- octinoxate, titanium dioxide emulsion

Bare Perfecting Makeup by

Drug Labeling and Warnings

Bare Perfecting Makeup by is a Otc medication manufactured, distributed, or labeled by Merle Norman Cosmetics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Perfecting Makeup Broad Spectrum SPF 25
Merle Norman

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

INGREDIENTS AND APPEARANCE

BARE PERFECTING MAKEUP  MERLE NORMAN
octinoxate, titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.25 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.13 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ISODODECANE (UNII: A8289P68Y2)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALUMINUM OXIDE (UNII: LMI26O6933)
STEARIC ACID (UNII: 4ELV7Z65AP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-123-02	1 in 1 CARTON	08/22/2012
1	NDC: 57627-123-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/22/2012

Labeler - Merle Norman Cosmetics, Inc (008479388)

Registrant - Merle Norman Cosmetics, Inc (008479388)

Establishment
Name	Address	ID/FEI	Business Operations
Merle Norman Cosmetics, Inc		008479388	manufacture(57627-123)