EQUALIZER- titanium dioxide lotion

EQUALIZER by

Drug Labeling and Warnings

EQUALIZER by is a Otc medication manufactured, distributed, or labeled by Estee Lauder Inc., ELGC Kabushiki Kaisha, Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ARAMIS, INC, ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

TITANIUM DIOXIDE 2.00%

INGREDIENTS

CYCLOPENTASILOXANE WATER BUTYLENE GLYCOL POLYMETHYL METHACRYLATE DIMETHICONE ISOTETRACOSANE HEXYLENE GLYCOL PEG/PPG-18/18 DIMETHICONE OCTYLDODECYL STEAROYL STEARATE HYDROLYZED SOY PROTEIN ISOSTEARYL NEOPENTANOATE CHAMOMILLA RECUTITA (MATRICARIA) EXTRACT LECITHIN COCONUT ACID DISTEARDIMONIUM HECTORITE C9-15 FLUOROALCOHOL PHOSPHATE POLYETHYLENE LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER POLYGLYCERYL-4 ISOSTEARATE HEXYL LAURATE CETYL PEG/PPG-10/1 DIMETHICONE TOCOPHERYL LINOLEATE/OLEATE SILICA SODIUM CHLORIDE LAURETH-7 PROPYLENE CARBONATE ALUMINA DISODIUM EDTA PHENOXYETHANOL [+/- MICA IRON OXIDES (CI 77491, CI 77492, CI 77499) TITANIUM DIOXIDE (CI 77891) CHROMIUM HYDROXIDE GREEN (CI 77289) CHROMIUM OXIDE GREENS (CI 77288)]

WARNING

Keep out of eyes.

Stop use if irritation occurs.

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL - 30 ml Carton

ESTĒE LAUDER

Equalizer
Smart Makeup

SPF 10

1 FL. OZ. LIQ./30ml e

INGREDIENTS AND APPEARANCE

EQUALIZER   SMART MAKEUP SPF 10
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-736
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
COCONUT ACID (UNII: 40U37V505D)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LAURETH-7 (UNII: Z95S6G8201)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ALUMINUM OXIDE (UNII: LMI26O6933)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-736-01	1 in 1 CARTON
1		30 mL in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/26/2008

Labeler - Estee Lauder Inc. (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC Kabushiki Kaisha		712808195	RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
ARAMIS, INC		042918826	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK, RELABEL

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		787336577	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		949264774	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		618107429	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE