Label: CLINIQUE- octisalate, homosalate, oxybenzone, avobenzone, and octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49527-716-01 - 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 October 15, 2011
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- WARNING
- ACTIVE INGREDIENTS
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INGREDIENTS
WATER • METHYL TRIMETHICONE • BUTYLENE GLYCOL • BUTYLOCTYL SALICYLATE • NEOPENTYL GLYCOL DIHEPTANOATE • BUTYROSPERMUM PARKII (SHEA BUTTER) • PEG-100 STEARATE • SILICA • DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • DIMETHICONE • GLYCERYL STEARATE • LAURDIMONIUM HYDROXYPROPYL HYDROLYZED SOY PROTEIN • ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT • PERILLA OCYMOIDES LEAF EXTRACT • PLANKTON EXTRACT • CAFFEINE • POTASSIUM CETYL PHOSPHATE • SUCROSE • STYRENE/ACRYLATES COPOLYMER • C30-38 OLEFIN/ISOPROPYL MALEATE/MA COPOLYMER • CETYL ALCOHOL • VP/EICOSENE COPOLYMER • ETHYLHEXYLGLYCERIN • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER • PEG-8 LAURATE • SODIUM RNA • PHOSPHOLIPIDS • LECITHIN • C1-8 ALKYL TETRAHYDROXYCYCLOHEXANOATE • HYDROXYETHYLCELLULOSE • TOCOPHERYL ACETATE • CAPRYLYL GLYCOL • ASCORBYL TOCOPHERYL MALEATE • STEARIC ACID • XANTHAN GUM • MALTODEXTRIN • FERULIC ACID • HEXYLENE GLYCOL • NORDIHYDROGUAIARETIC ACID • DISODIUM EDTA • PHENOXYETHANOL • MICA • SODIUM DEHYDROACETATE [ILN35074]
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Carton
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INGREDIENTS AND APPEARANCE
CLINIQUE SPF 30 WITH SOLAR SMART
octisalate, homosalate, oxybenzone, avobenzone, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-716 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W) octisalate 5 mL in 100 mL homosalate (UNII: V06SV4M95S) (homosalate - UNII:V06SV4M95S) homosalate 5 mL in 100 mL oxybenzone (UNII: 95OOS7VE0Y) (oxybenzone - UNII:95OOS7VE0Y) oxybenzone 4 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) methyl trimethicone (UNII: S73ZQI0GXM) butylene glycol (UNII: 3XUS85K0RA) butyloctyl salicylate (UNII: 2EH13UN8D3) neopentyl glycol diheptanoate (UNII: 5LKW3C543X) shea butter (UNII: K49155WL9Y) peg-100 stearate (UNII: YD01N1999R) silicon dioxide (UNII: ETJ7Z6XBU4) dimethicone (UNII: 92RU3N3Y1O) glyceryl monostearate (UNII: 230OU9XXE4) rosemary (UNII: IJ67X351P9) perilla frutescens leaf (UNII: T4L5881Y68) caffeine (UNII: 3G6A5W338E) potassium cetyl phosphate (UNII: 03KCY6P7UT) sucrose (UNII: C151H8M554) cetyl alcohol (UNII: 936JST6JCN) ethylhexylglycerin (UNII: 147D247K3P) peg-8 laurate (UNII: 762O8IWA10) alpha-tocopherol acetate (UNII: 9E8X80D2L0) caprylyl glycol (UNII: 00YIU5438U) stearic acid (UNII: 4ELV7Z65AP) xanthan gum (UNII: TTV12P4NEE) maltodextrin (UNII: 7CVR7L4A2D) ferulic acid (UNII: AVM951ZWST) hexylene glycol (UNII: KEH0A3F75J) masoprocol (UNII: 7BO8G1BYQU) edetate disodium (UNII: 7FLD91C86K) phenoxyethanol (UNII: HIE492ZZ3T) mica (UNII: V8A1AW0880) sodium dehydroacetate (UNII: 8W46YN971G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-716-01 1 in 1 CARTON 1 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 09/01/2010 Labeler - CLINIQUE LABORATORIES INC. (173047747) Establishment Name Address ID/FEI Business Operations ELGC Kabushiki Kaisha 712808195 RELABEL, REPACK Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE, RELABEL, REPACK Establishment Name Address ID/FEI Business Operations ARAMIS, INC 042918826 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 COSMETICS, LTD 253616536 MANUFACTURE Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE 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 NORTEC KEYSTONE 787336577 MANUFACTURE, RELABEL, REPACK 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 WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE