Label: CLINIQUE SPF 15 WITH SOLAR SMART ADVANCED PROTECTION- homosalate, octisalate, avobenzone, and octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49527-735-01 - Packager: CLINIQUE LABORATORIES 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 August 6, 2012
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- TO USE
- WARNING
- ACTIVE INGREDIENTS
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INGREDIENTS
WATER • BUTYLENE GLYCOL • ISONONYL ISONONANDATE • BUTYLOCTYL SALICYLATE • TRIACONTANYL PVP • POLYESTER-8 • SILICA • ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT • PERILLA OCYMOIDES LEAF EXTRACT • STEARYL DIMETHICONE • CAFFEINE • PLANKTON EXTRACT • SUCROSE • HYDROGENATED LECITHIN • POTASSIUM CETYL PHOSPHATE • LAURDIMONIUM HYDROXYPROPYL HYDROLYZED SOY PROTEIN • PEG-100 STEARATE • CETYL ALCOHOL • POLYETHYLENE • ACRYLIC ACID/VP CROSSPOLYMER • VP/EICOSENE COPOLYMER • TOCOPHERYL ACETATE • TROMETHAMINE • SODIUM RNA • ALOE BARBADENSIS POWDER • PHOSPHOLIPIDS • LECITHIN • MAGNESIUM ASCORBYL PHOSPHATE • SODIUM HYALURONATE • HYDROXYPROPYL METHYLCELLULOSE • C1-8 ALKYL TETRAHYDROXYCYCLOHEXANOATE • HYDROXYETHYLCELLULOSE • ASCORBYL TOCOPHERYL MALEATE • MALTODEXTRIN • CAPRYLYL GLYCOL • HEXYLENE GLYCOL • NORDIHYDROGUAIARETIC ACID • FERULIC ACID • DISODIUM EDTA • PHENOXYETHANOL • CHLORPHENESIN • MICA [ILN34995]
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 150 ml Carton
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INGREDIENTS AND APPEARANCE
CLINIQUE SPF 15 WITH SOLAR SMART ADVANCED PROTECTION
homosalate, octisalate, avobenzone, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-735 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength homosalate (UNII: V06SV4M95S) (homosalate - UNII:V06SV4M95S) homosalate 10 mL in 100 mL octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W) octisalate 5 mL in 100 mL avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX) avobenzone 3 mL in 100 mL octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM) octocrylene 2.7 mL in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) butylene glycol (UNII: 3XUS85K0RA) isononyl isononanoate (UNII: S4V5BS6GCX) butyloctyl salicylate (UNII: 2EH13UN8D3) triacontanyl pvp (wp-660) (UNII: N0SS3Q238D) silicon dioxide (UNII: ETJ7Z6XBU4) rosemary (UNII: IJ67X351P9) perilla frutescens leaf (UNII: T4L5881Y68) caffeine (UNII: 3G6A5W338E) sucrose (UNII: C151H8M554) potassium cetyl phosphate (UNII: 03KCY6P7UT) peg-100 stearate (UNII: YD01N1999R) cetyl alcohol (UNII: 936JST6JCN) high density polyethylene (UNII: UG00KM4WR7) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) tromethamine (UNII: 023C2WHX2V) magnesium ascorbyl phosphate (UNII: 0R822556M5) hyaluronate sodium (UNII: YSE9PPT4TH) maltodextrin (UNII: 7CVR7L4A2D) caprylyl glycol (UNII: 00YIU5438U) hexylene glycol (UNII: KEH0A3F75J) masoprocol (UNII: 7BO8G1BYQU) ferulic acid (UNII: AVM951ZWST) edetate disodium (UNII: 7FLD91C86K) phenoxyethanol (UNII: HIE492ZZ3T) chlorphenesin (UNII: I670DAL4SZ) mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-735-01 1 in 1 CARTON 1 150 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/01/2009 Labeler - CLINIQUE LABORATORIES INC. (173047747) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(49527-735) , REPACK(49527-735) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(49527-735) , RELABEL(49527-735) , REPACK(49527-735) Establishment Name Address ID/FEI Business Operations Estee Lauder Inc. 042918826 MANUFACTURE(49527-735) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(49527-735) , RELABEL(49527-735) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(49527-735) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(49527-735) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(49527-735) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(49527-735) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(49527-735) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(49527-735) , RELABEL(49527-735) , REPACK(49527-735) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(49527-735) , RELABEL(49527-735) , REPACK(49527-735) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(49527-735) , RELABEL(49527-735) , REPACK(49527-735) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(49527-735) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(49527-735) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(49527-735) , RELABEL(49527-735)
