MOISTURE RICH FOUNDATION SPF 15- octinoxate lipstick

MOISTURE RICH FOUNDATION by

Drug Labeling and Warnings

MOISTURE RICH FOUNDATION by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER N.V., Len-Ron Manufacturing Division of Aramis Inc., Aramis Inc., Northtec Bristol, Northtec Keystone, Estee Lauder Pennsylvania Distribution Center 2, Estee Lauder Cosmetics, Ltd., Estee Lauder Cosmetics, Ltd, Estee Lauder Cosmetics Distribution Center, Estee Lauder Kabushiki Kaisha, Whitman Laboratories Ltd., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT: OCTINOXATE 2.2%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: WATER\AQUA\EAU [] PHENYL TRIMETHICONE [] CAPRYLYL METHICONE [] DIMETHICONE [] BUTYLENE GLYCOL [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] ISOCETYL ALCOHOL [] ISOHEXADECANE [] WHEAT GERM GLYCERIDES [] PEG/PPG-18/18 DIMETHICONE [] MAGNESIUM SULFATE [] PEG-10 DIMETHICONE [] PEG-10 DIMETHICONE CROSSPOLYMER [] TOCOPHERYL ACETATE [] DISTEARDIMONIUM HECTORITE [] CETYL PEG/PPG-10/1 DIMETHICONE [] SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL [] SODIUM HYALURONATE [] ASCORBYL PALMITATE [] CHOLESTEROL [] LINOLEIC ACID [] HYDROGENATED LECITHIN [] LAVANDULA ANGUSTIFOLIA (LAVENDER) [] TRIETHYL CITRATE [] HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER [] PROPYLENE CARBONATE [] SORBITAN STEARATE [] LAURETH-7 [] XANTHAN GUM [] TRIETHOXYCAPRYLYLSILANE [] LECITHIN [] SILICA [] LINALOOL [] PHENOXYETHANOL [] CHLOROXYLENOL []  [+/- TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] MICA]

WARNINGS

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:

BOBBI BROWN

MOISTURE RICH FOUNDATION

SPF 15

30 ML/ 1 FL OZ LIQ

DISTR BOBBI BROWN COSMETICS INC

NEW YORK, NY 10022

INGREDIENTS AND APPEARANCE

MOISTURE RICH FOUNDATION  SPF 15
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-704
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)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOCETYL ALCOHOL (UNII: 1800H64066)
ISOHEXADECANE (UNII: 918X1OUF1E)
WHEAT GERM (UNII: YR3G369F5A)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
JOJOBA OIL (UNII: 724GKU717M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CHOLESTEROL (UNII: 97C5T2UQ7J)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
LAURETH-7 (UNII: Z95S6G8201)
XANTHAN GUM (UNII: TTV12P4NEE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-704-01	1 in 1 CARTON
1	NDC: 64141-704-02	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	10/01/2000

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

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
Aramis Inc.		042918826	manufacture

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
Estee Lauder Pennsylvania Distribution Center 2		828534516	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd.		255175580	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd		253616536	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 Kabushiki Kaisha		712808195	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