![CAMERA READY BB BROAD SPECTRUM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [SMASHBOX BEAUTY COSMETICS, INC]](https://medic.hrt.org//dailymed/images/00d0993b-88d7-4a0f-ad2c-d37e3cf6cf0a/c004-01.jpg)
| NDC | 10348-015-01 |
| Set ID | 00d0993b-88d7-4a0f-ad2c-d37e3cf6cf0a |
| Category | HUMAN OTC DRUG LABEL |
| Packager | SMASHBOX BEAUTY COSMETICS, INC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Use
- Warnings
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Directions
For sunscreen use:
- apply liberally and evenly 15 minutes before sun exposure
- reapply at least every two hours
- use a water resistant sunscreen if swimming or sweating
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age: ask a doctor
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Inactive Ingredients
Water\Aqua\Eau, Dimethicone, Butylene Glycol, Phenyl Trimethicone, Pentylene Glycol, Glyceryl Stearate, Behenyl Alcohol, Trioctyldoceyl Citrate, Polymethylsilsesquioxane, Octyldodecyl Stearoyl Stearate, PEG-40 Stearate, Polyglyceryl-10 Pentastearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Triticum Vulgare (Wheat) Germ Extract, Hordeum Vulgare (Barley) Extract\Extrait D'Orge, Cucumis Sativus (Cucumber) Fruit Extract, Laminaria Saccharina Extract, Pyrus Malus (Apple) Fruit Extract, Scutellaria Baicalensis Root Extract, Polyquaternium-51, Acetyl Hexapeptide-8, Trehalose, Oryzanol, Octydodecyl 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, Poly-sorbate 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] <ILN37872>
- Other information
- PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton
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INGREDIENTS AND APPEARANCE
CAMERA READY BB BROAD SPECTRUM SPF 35
octinoxate, octisalate, oxybenzone, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10348-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.078 g in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.0416 g in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.026 g in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.0114 g in 1 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) TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C) PEG-40 STEARATE (UNII: ECU18C66Q7) POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) WHEAT (UNII: 4J2I0SN84Y) BARLEY (UNII: 5PWM7YLI7R) CUCUMBER (UNII: YY7C30VXJT) APPLE (UNII: B423VGH5S9) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) TREHALOSE (UNII: B8WCK70T7I) ORYZANOL (UNII: SST9XCL51M) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) UREA (UNII: 8W8T17847W) PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3) ENOXOLONE (UNII: P540XA09DR) SUCROSE (UNII: C151H8M554) GLYCERIN (UNII: PDC6A3C0OX) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) CAFFEINE (UNII: 3G6A5W338E) LINOLEIC ACID (UNII: 9KJL21T0QJ) CHOLESTEROL (UNII: 97C5T2UQ7J) SQUALANE (UNII: GW89575KF9) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0) 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) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) CHLORPHENESIN (UNII: I670DAL4SZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) ZINC OXIDE (UNII: SOI2LOH54Z) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10348-015-01 1 in 1 CARTON 01/01/2012 1 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2012 Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 MANUFACTURE(10348-015) , REPACK(10348-015) , RELABEL(10348-015) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 REPACK(10348-015) , RELABEL(10348-015) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 202952982 MANUFACTURE(10348-015) , REPACK(10348-015) , RELABEL(10348-015) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 MANUFACTURE(10348-015) , REPACK(10348-015) , RELABEL(10348-015) Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 MANUFACTURE(10348-015) , REPACK(10348-015) , RELABEL(10348-015) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 REPACK(10348-015) , RELABEL(10348-015) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 REPACK(10348-015) , RELABEL(10348-015) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd 204132062 REPACK(10348-015) , RELABEL(10348-015) Establishment Name Address ID/FEI Business Operations NORTHTEC PALC 102631997 REPACK(10348-015) , RELABEL(10348-015)
