DOUBLE MATTE OIL CONTROL MAKEUP SPF 15- octinoxate liquid

DOUBLE MATTE by

Drug Labeling and Warnings

DOUBLE MATTE 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

OCTINOXATE 2.20%

INGREDIENTS

WATERCYCLOPENTASILOXANETRIMETHYLSILOXYSILICATEBUTYLENE GLYCOLSILICAPEG/PPG-18/18 DIMETHICONEPOLYGLYCERYL-3 DIISOSTEARATEMAGNESIUM SULFATETRIBEHENINHYDROLYZED SOY PROTEINCOCONUT ACIDCHAMOMILLA RECUTITA (MATRICARIA) EXTRACT URTICA DIOICA (NETTLE) EXTRACTMELISSA OFFICINALIS (BALM MINT) EXTRACTEQUISETUM HIEMALE (HORSETAIL) EXTRACTAESCULUS HIPPOCASTANUM (HORSE CHESTNUT) BARK EXTRACTROSMARINUS OFFICINALIS (ROSEMARY) EXTRACTSALVIA OFFICINALIS (SAGE) LEAF EXTRACTPHENYL TRIMETHICONEKAOLINPROPYLENE CARBONATEMETHICONETRIETHYL CITRATEDISTEARDIMONIUM HECTORITELAURETH-7CELLULOSE GUMALUMINADISODIUM EDTABHTPOTASSIUM SORBATEPHENOXYETHANOL[+/- MICATITANIUM DIOXIDE (CI 77891)IRON OXIDES (CI 77491, CI 77492, CI 77499)]

SPL UNCLASSIFIED SECTION

© ESTĒE LAUDER, DIST.
NEW YORK, N.Y. 10022

WARNING

Keep out of eyes.

Stop use if irritation occurs.

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL - 30 ml Carton

ESTĒE LAUDER

Double Matte
Oil Control Makeup
SPF 15

1 FL. OZ. LIQ./30 ml e

INGREDIENTS AND APPEARANCE

DOUBLE MATTE   OIL CONTROL MAKEUP SPF 15
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-732
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
COCONUT ACID (UNII: 40U37V505D)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
MELISSA OFFICINALIS (UNII: YF70189L0N)
EQUISETUM HYEMALE (UNII: 59677RXH25)
AESCULUS HIPPOCASTANUM BARK (UNII: 7U76MXL14N)
ROSEMARY (UNII: IJ67X351P9)
SAGE (UNII: 065C5D077J)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
KAOLIN (UNII: 24H4NWX5CO)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
LAURETH-7 (UNII: Z95S6G8201)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ALUMINUM OXIDE (UNII: LMI26O6933)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
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: 11559-732-01	1 in 1 CARTON
1		30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/1998

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