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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 4.00% [] OXYBENZONE 2.50% [] TITANIUM DIOXIDE 1.10%

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

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

KEEP OUT OF REACH OF CHILDREN.

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


folding carton

SMASHBOX   CAMERA READY 5 IN 1 BEAUTY BALM SPF 35
octinoxlate, octisalate, oxybenzone, titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0043
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.0 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40046-0043-11 in 1 CARTON
1NDC:40046-0043-230 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2011
Labeler - MAKEUP ART COSMETICS (010597206)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIBusiness Operations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058manufacture

Revised: 5/2011
Document Id: 91e3d67c-7165-4b28-9971-eea8e344c183
Set id: 8bb7d802-f1b3-4adc-ba94-515c73261632
Version: 1
Effective Time: 20110527
 
MAKEUP ART COSMETICS