Label: BB10 INSTANT SKIN PERFECTOR BROAD SPECTRUM SPF 35- octinoxate, octisalate, oxybenzone, and titanium dioxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 68758-010-01 - Packager: GOOD SKIN DERMACARE
- 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 October 4, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
For sunscreen use:
- apply generously 15 minutes before sun exposure
- reapply 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 SPF 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, Trioctyldodecyl Citrate, Polymethylsilsesquioxane, Octyldodecyl Stearoyl Stearate, PEG-40 Stearate, Polyglyceryl-10 Pentastearate, Tocopheryl Acetate, Sodium Hyaluronate, Lecithin, Squalane, Cucumis Sativus (Cucumber) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Scutellaria Baicalensis Root Extract, Hordeum Vulgare (Barley) Extract\Extrait d'Orge, Laminaria Saccharina Extract, Triticum Vulgare (Wheat) Germ Extract, Caffeine, Glycerin, Cholesterol, Sodium PCA, Polyglyceryl-6 Polyricinoleate, Octyldodecyl Neopentanoate, Acetyl Hexapeptide-8, Oryzanol, Trehalose, Sucrose, Alumina, Silica, Urea, Xanthan Gum, Ammonium Acryloyldimethyltaurate/VP Copolymer, Polyquaternium-51, Sodium Stearoyl Lactylate, Polysorbate 20, Sorbitan Laurate, Propylene Glycol Laurate, Stearic Acid, Glycyrrhetinic Acid, Linoleic Acid, Isopropyl Titanium Triisostearate, Propylene Glycol Stearate, Disodium EDTA, Phenoxyethanol, Chlorphenesin, Sodium Dehydroacetate, [+/- Mica, Titanium Dioxide (CI 77891), Iron Oxides (Ci 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Zinc Oxide (CI 77947)] [ILN39504]
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
BB10 INSTANT SKIN PERFECTOR BROAD SPECTRUM SPF 35
octinoxate, octisalate, oxybenzone, and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68758-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.08175 g in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.0436 g in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.02725 g in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.01199 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) Octyldodecyl Stearoyl Stearate (UNII: 3D47Q6D93C) PEG-40 Stearate (UNII: ECU18C66Q7) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Hyaluronate Sodium (UNII: YSE9PPT4TH) Squalane (UNII: GW89575KF9) Cucumber (UNII: YY7C30VXJT) Apple (UNII: B423VGH5S9) Scutellaria Baicalensis Root (UNII: 7J95K7ID2S) Barley (UNII: 5PWM7YLI7R) Saccharina Latissima (UNII: 68CMP2MB55) Wheat Germ (UNII: YR3G369F5A) Caffeine (UNII: 3G6A5W338E) Glycerin (UNII: PDC6A3C0OX) Cholesterol (UNII: 97C5T2UQ7J) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Octyldodecyl Neopentanoate (UNII: X8725R883T) Acetyl Hexapeptide-8 (UNII: L4EL31FWIL) Gamma Oryzanol (UNII: SST9XCL51M) Trehalose (UNII: B8WCK70T7I) Sucrose (UNII: C151H8M554) Aluminum Oxide (UNII: LMI26O6933) Silicon Dioxide (UNII: ETJ7Z6XBU4) Urea (UNII: 8W8T17847W) Xanthan Gum (UNII: TTV12P4NEE) Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG) Sodium Stearoyl Lactylate (UNII: IN99IT31LN) Polysorbate 20 (UNII: 7T1F30V5YH) Sorbitan Monolaurate (UNII: 6W9PS8B71J) Propylene Glycol Monolaurate (UNII: 668Z5835Z3) Stearic Acid (UNII: 4ELV7Z65AP) Enoxolone (UNII: P540XA09DR) Linoleic Acid (UNII: 9KJL21T0QJ) Isopropyl Titanium Triisostearate (UNII: 949E3KBJ1I) Propylene Glycol Stearate (UNII: MZM1I680W0) Edetate Disodium (UNII: 7FLD91C86K) Phenoxyethanol (UNII: HIE492ZZ3T) Chlorphenesin (UNII: I670DAL4SZ) Sodium Dehydroacetate (UNII: 8W46YN971G) Mica (UNII: V8A1AW0880) Ferric Oxide Red (UNII: 1K09F3G675) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferrosoferric Oxide (UNII: XM0M87F357) Zinc Oxide (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68758-010-01 1 in 1 CARTON 1 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 10/27/2011 Labeler - GOOD SKIN DERMACARE (143367634) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(68758-010) , REPACK(68758-010) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(68758-010) , RELABEL(68758-010) , REPACK(68758-010) Establishment Name Address ID/FEI Business Operations Estee Lauder Inc. 042918826 MANUFACTURE(68758-010) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(68758-010) , RELABEL(68758-010) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(68758-010) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(68758-010) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(68758-010) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(68758-010) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(68758-010) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(68758-010) , RELABEL(68758-010) , REPACK(68758-010) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(68758-010) , RELABEL(68758-010) , REPACK(68758-010) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(68758-010) , RELABEL(68758-010) , REPACK(68758-010) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(68758-010) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(68758-010) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(68758-010) , RELABEL(68758-010)
