Label: BOBBIE BROWN CORRECTIVE SPOT TREATMENT BROAD SPECTRUM SPF 25- octinoxate and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 64141-113-01 - Packager: Bobbi Brown Professional Cosmetics Inc.
- 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)
- Drug Facts
- Active Ingredients
- Purpose
- Use
- Warnings
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Directions
For sunscreen use:
- apply liberally 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 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
isododecane • talc • trimethylsiloxysilicate • polyethylene • alumina • diphenylsiloxy phenyl trimethicone • disteardimonium hectorite • microcrystalline wax\cera microcristallina\cire microcristalline • ascorbyl glucoside • morus nigra (mulberry) root extract • hydrolyzed rice bran extract • scutellaria baicalensis root extract • vitis vinifera (grape) fruit extract • gentiana lutea (gentian) root extract • cholesterol • stearyl glycyrrhetinate • sucrose • dimethicone • propylene carbonate • sorbitan sesquiisostearate • linoleic acid • butylene glycol • aluminum hydroxide • methicone • tocopherol • water\aqua\eau • phenoxyethanol • [+/- mica • iron oxides (ci 77492) • iron oxides (ci 77491) • iron oxides (ci 77499) • titanium dioxide (ci 77891)] <iln39231>
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4.5 ML Tube Carton
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INGREDIENTS AND APPEARANCE
BOBBIE BROWN CORRECTIVE SPOT TREATMENT BROAD SPECTRUM SPF 25
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-113 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 98 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 15.4 mg in 1 mL Inactive Ingredients Ingredient Name Strength isododecane (UNII: A8289P68Y2) talc (UNII: 7SEV7J4R1U) high density polyethylene (UNII: UG00KM4WR7) aluminum oxide (UNII: LMI26O6933) diphenylsiloxy phenyl trimethicone (UNII: I445L28B12) microcrystalline wax (UNII: XOF597Q3KY) ascorbyl glucoside (UNII: 2V52R0NHXW) morus nigra root (UNII: 033456LFG1) scutellaria baicalensis root (UNII: 7J95K7ID2S) wine grape (UNII: 3GOV20705G) gentiana lutea root (UNII: S72O3284MS) cholesterol (UNII: 97C5T2UQ7J) stearyl glycyrrhetinate (UNII: 3YYE6VJS0P) sucrose (UNII: C151H8M554) dimethicone (UNII: 92RU3N3Y1O) propylene carbonate (UNII: 8D08K3S51E) linoleic acid (UNII: 9KJL21T0QJ) butylene glycol (UNII: 3XUS85K0RA) aluminum hydroxide (UNII: 5QB0T2IUN0) tocopherol (UNII: R0ZB2556P8) water (UNII: 059QF0KO0R) phenoxyethanol (UNII: HIE492ZZ3T) mica (UNII: V8A1AW0880) ferric oxide yellow (UNII: EX438O2MRT) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64141-113-01 1 in 1 CARTON 1 4.5 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 04/10/2012 Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(64141-113) , REPACK(64141-113) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(64141-113) , RELABEL(64141-113) , REPACK(64141-113) Establishment Name Address ID/FEI Business Operations Estee Lauder Inc. 042918826 MANUFACTURE(64141-113) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(64141-113) , RELABEL(64141-113) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(64141-113) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(64141-113) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(64141-113) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(64141-113) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(64141-113) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(64141-113) , RELABEL(64141-113) , REPACK(64141-113) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(64141-113) , RELABEL(64141-113) , REPACK(64141-113) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(64141-113) , RELABEL(64141-113) , REPACK(64141-113) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(64141-113) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(64141-113) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(64141-113) , RELABEL(64141-113) Establishment Name Address ID/FEI Business Operations NIPPON SHIKAZAI 692572936 MANUFACTURE(64141-113)
