REDNESS SOLUTIONS MAKEUP SPF 15 WITH PROBIOTIC TECHNOLOGY- octinoxate, titanium dioxide, zinc oxide lotion

REDNESS SOLUTIONS MAKEUP by

Drug Labeling and Warnings

REDNESS SOLUTIONS MAKEUP by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES 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 ingredients: octinoxate 5.90% [] titanium dioxide 3.70% [] zinc oxide 2.90%

INACTIVE INGREDIENT

inactive ingredients: water [] methyl trimethicone [] phenyl trimethicone [] dimethicone [] triethylhexanoin [] butylene glycol [] trimethylsiloxysilicate [] peg-10 dimethicone [] lauryl peg-9 polydimethylsiloxyethyl dimethicone [] aluminum hydroxide [] c12-15 alkyl benzoate [] lactobacillus ferment [] citrus grandis (grapefruit) peel extract [] magnolia grandiflora bark extract [] poria cocos sclerotium extract [] astrocaryum murumuru seed butter [] glycerin [] caffeine [] sodium myristoyl sarcosinate [] caprylyl methicone [] methicone [] polyglyceryl-6 polyricinoleate [] disteardimonium hectorite [] acetyl glucosamine [] isopropyl titanium triisostearate [] dimethicone crosspolymer-3 [] lecithin [] tocopheryl acetate [] laureth-7 [] dimethicone/peg-10/15 crosspolymer [] sodium chloride [] dipropylene glycol [] disodium edta [] polyaminopropyl biguanide [] phenoxyethanol []  [+/- mica [] titanium dioxide (ci 77891) [] iron oxides (ci 77491, ci 77492, ci 77499)]

WARNINGS

warning:keep out of eyes. discontinue use if irritation occurs. keep out of reach of children.

PRINCIPAL DISPLAY PANEL

principal display panel:

CLINIQUE

REDNESS

SOLUTIONS

MAKE UP SPF 15

with probiotic technology

1 fl oz liq/ 30 ml

clinique laboratories, dist

new york, ny 10022

INGREDIENTS AND APPEARANCE

REDNESS SOLUTIONS MAKEUP  SPF 15 WITH PROBIOTIC TECHNOLOGY
octinoxate, titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5.9 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.7 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.9 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
LACTOBACILLUS HELVETICUS (UNII: Q08Z44662J)
CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6)
MAGNOLIA GRANDIFLORA BARK (UNII: J4XF5T6418)
FU LING (UNII: XH37TWY5O4)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
GLYCERIN (UNII: PDC6A3C0OX)
CAFFEINE (UNII: 3G6A5W338E)
SODIUM MYRISTOYL ISETHIONATE (UNII: 8D42TA2T6V)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAURETH-7 (UNII: Z95S6G8201)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-005-01	1 in 1 CARTON
1	NDC: 49527-005-02	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	12/01/2010

Labeler - CLINIQUE LABORATORIES INC (173047747)

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