SMASHBOX- octinoxlate, octisalate, oxybenzone, titanium dioxide liquid

SMASHBOX by

Drug Labeling and Warnings

SMASHBOX by is a Otc medication manufactured, distributed, or labeled by MAKEUP ART COSMETICS, 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 7.50% [] OCTISALATE 4.00% [] OXYBENZONE 2.50% [] TITANIUM DIOXIDE 1.10%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: WATER [] DIMETHICONE [] BUTYLENE GLYCOL [] PHENYL TRIMETHICONE [] PENTYLENE GLYCOL [] GLYCERYL STEARATE [] BEHENYL ALCOHOL [] TRIOCTYLDODECYL CITRATE [] POLYMETHYLSILSESQUIOXANE [] OCTYLDODECYL STEAROYL STEARATE [] PEG-40 STEARATE [] POLYGLYCERYL-10 PENTASTEARATE [] AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] HORDEUM VULGARE (BARLEY) EXTRACT [] CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT [] LAMINARIA SACCHARINA EXTRACT [] PYRUS MALUS (APPLE) FRUIT EXTRACT [] SCUTELLARIA BAICALENSIS ROOT EXTRACT [] POLYQUATERNIUM-51 [] ACETYL HEXAPEPTIDE-8 [] TREHALOSE [] ORYZANOL [] OCTYLDODECYL NEOPENTANOATE [] UREA [] POLYGLYCERYL-6 POLYRICINOLEATE [] PROPYLENE GLYCOL LAURATE [] GLYCYRRHETINIC ACID [] TOCOPHERYL ACETATE [] SUCROSE [] GLYCERIN [] SODIUM STEAROYL LACTYLATE [] CAFFEINE [] LINOLEIC ACID [] CHOLESTEROL [] LECITHIN [] SQUALANE [] SODIUM PCA [] ISOPROPYL TITANIUM TRIISOSTEARATE [] PROPYLENE GLYCOL STEARATE [] STEARIC ACID [] POLYSORBATE 20 [] SORBITAN LAURATE [] XANTHAN GUM [] ALUMINUM HYDROXIDE [] SODIUM HYALURONATE [] SILICA [] DISODIUM EDTA [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] SODIUM DEHYDROACETATE [] CHLORPHENESIN [] PHENOXYETHANOL []  [+/- TITANIUM DIOXIDE (CI 77891) [] ZINC OXIDE (CI 77947) [] 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:

SMASHBOX CAMERA READY

5 IN 1

BEAUTY BALM

SPF 35

1.0 FL OZ/ 30 ML

MAKE-UP ART COSMETICS, DISTRIBUTOR
Smashbox Beauty Cosmetics Inc.

made in canada

INGREDIENTS AND APPEARANCE

SMASHBOX   CAMERA READY 5 IN 1 BEAUTY BALM SPF 35
octinoxlate, octisalate, oxybenzone, titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40046-0043
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.0 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2.5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.1 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DOCOSANOL (UNII: 9G1OE216XY)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
PEG-40 STEARATE (UNII: ECU18C66Q7)
WHEAT GERM (UNII: YR3G369F5A)
CUCUMBER (UNII: YY7C30VXJT)
SACCHARINA LATISSIMA (UNII: RTR3OGP8ET)
APPLE (UNII: B423VGH5S9)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL)
TREHALOSE (UNII: B8WCK70T7I)
GAMMA ORYZANOL (UNII: SST9XCL51M)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
UREA (UNII: 8W8T17847W)
PROPYLENE GLYCOL MONOLAURATE (UNII: M4AW13H75T)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SUCROSE (UNII: C151H8M554)
GLYCERIN (UNII: PDC6A3C0OX)
CAFFEINE (UNII: 3G6A5W338E)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
CHOLESTEROL (UNII: 97C5T2UQ7J)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SQUALANE (UNII: GW89575KF9)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PROPYLENE GLYCOL MONOSTEARATE (UNII: F76354LMGR)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
XANTHAN GUM (UNII: TTV12P4NEE)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40046-0043-1	1 in 1 CARTON
1	NDC: 40046-0043-2	30 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2011

Labeler - MAKEUP ART COSMETICS (010597206)

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