Label: REPAIRWEAR LASERFOCUS ALL SMOOTH MAKEUP SPF 15- titanium dioxide, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 49527-011-01, 49527-011-02 - Packager: CLINIQUE LABORATORIES INC
- Category: HUMAN OTC DRUG LABEL
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 June 23, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
inactive ingredients: water [] methyl trimethicone [] phenyl trimethicone [] dimethicone [] triethylhexanoin [] butylene glycol [] trimethylsiloxysilicate [] peg-10 dimethicone [] lauryl peg-9 polydimethylsiloxyethyl dimethicone [] glycerin [] alumina [] astrocaryum murumuru seed butter [] whey protein\lactis protein\protéine du petit-lait [] sigesbeckia orientalis (st. paul's wort) extract [] micrococcus lysate [] acetyl hexapeptide-8 [] sodium hyaluronate [] palmitoyl oligopeptide [] sodium myristoyl sarcosinate [] dimethicone/peg-10/15 crosspolymer [] sodium chloride [] tocopheryl acetate [] acetyl glucosamine [] glyceryl polymethacrylate [] methicone [] disteardimonium hectorite [] lecithin [] dimethicone crosspolymer-3 [] peg-8 [] laureth-7 [] dipropylene glycol [] disodium edta [] polyaminopropyl biguanide [] phenoxyethanol [] [+/- mica [] titanium dioxide (ci 77891) [] iron oxides (ci 77491, ci 77492, ci 77499) [] bismuth oxychloride (ci 77163)]
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REPAIRWEAR LASERFOCUS ALL SMOOTH MAKEUP SPF 15
titanium dioxide, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.9 mL in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.0 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE (UNII: 92RU3N3Y1O) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM OXIDE (UNII: LMI26O6933) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) WHEY (UNII: 8617Z5FMF6) ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C) SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y) LAURETH-7 (UNII: Z95S6G8201) DIPROPYLENE GLYCOL (UNII: E107L85C40) EDETATE DISODIUM (UNII: 7FLD91C86K) POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-011-01 1 in 1 CARTON 1 NDC:49527-011-02 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 06/01/2011 Labeler - CLINIQUE LABORATORIES INC (173047747) 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