RENUTRIV ULTIMATE RADIANCE MAKEUP SPF 15- octinoxate, titanium dioxide liquid

RENUTRIV by

Drug Labeling and Warnings

RENUTRIV by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER 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 2.20% [] TITANIUM DIOXIDE 1.40%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: WATER\AQUA\EAU [] CYCLOPENTASILOXANE [] PHENYL TRIMETHICONE [] BUTYLENE GLYCOL [] DIMETHICONE [] ISOCETYL ALCOHOL [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] ISOHEXADECANE [] WHEAT GERM GLYCERIDES [] PEG/PPG-20/20 DIMETHICONE [] SORBITAN SESQUIOLEATE [] MAGNESIUM SULFATE [] TRIBEHENIN [] HYDROLYZED WHEAT PROTEIN [] POLYSILICONE-11 [] RUBY POWDER [] SAPPHIRE POWDER [] NEPHRITE POWDER [] ETHYLHEXYLGLYCERIN [] PEARL POWDER [] LAURETH-7 [] METHICONE [] SORBITAN STEARATE [] CHOLESTEROL [] HYDROGENATED LECITHIN [] SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL [] TRIETHYL CITRATE [] LINOLEIC ACID [] DISTEARDIMONIUM HECTORITE [] ETHYLHEXYL PALMITATE [] POLYMETHYLSILSESQUIOXANE [] PROPYLENE CARBONATE [] SODIUM HYALURONATE [] GOLD [] AMETHYST [] BORON NITRIDE [] TRIETHOXYCAPRYLYLSILANE [] ALUMINA [] SORBITAN ISOSTEARATE [] PALMITOYL OLIGOPEPTIDE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] CETYL PEG/PPG-10/1 DIMETHICONE [] XANTHAN GUM [] ASCORBYL PALMITATE [] TOCOPHERYL ACETATE [] CHLOROXYLENOL [] PHENOXYETHANOL []  [+/- 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

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

ESTEE LAUDER

RE-NUTRIV

ULTIMATE RADIANCE MAKEUP

SPF 15

1 FL OZ LIQUID/30 ML

ESTEE LAUDER DISTR.

NY, NY 10022

INGREDIENTS AND APPEARANCE

RENUTRIV  ULTIMATE RADIANCE MAKEUP SPF 15
octinoxate, titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-746
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.4 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-746-01	1 in 1 CARTON
1	NDC: 11559-746-02	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	09/01/2010

Labeler - ESTEE LAUDER INC (005914387)

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