Label: SMASHBOX- octinoxlate, octisalate, oxybenzone, titanium dioxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 40046-0043-1, 40046-0043-2 - Packager: MAKEUP ART COSMETICS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 27, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SMASHBOX CAMERA READY 5 IN 1 BEAUTY BALM SPF 35
octinoxlate, octisalate, oxybenzone, titanium dioxide liquidProduct 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
