Label: CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15- titanium dioxide and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49527-722-01 - 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 December 1, 2011
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- Official Label (Printer Friendly)
- WARNING
- ACTIVE INGREDIENTS
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INGREDIENTS
WATER • TRIOCTYLDODECYL CITRATE • CYCLOPENTASILOXANE • BUTYLENE GLYCOL • C12-15 ALKYL BENZOATE • STEARETH-2 • STEARYL DIMETHICONE • TRICAPRYLYL CITRATE • SILICA • BARIUM SULFATE • SORBITAN TRISTEARATE • ALUMINUM STEARATE • ASCOPHYLLUM NODOSUM EXTRACT • ASPARAGOPSIS ARMATA EXTRACT • LECITHIN • SEA WHIP EXTRACT • GLYCERYL STEARATE • TOCOPHERYL ACETATE • PEG-100 STEARATE • SUCROSE • PANTETHINE • CAFFEINE • OCTYLDODECYL NEOPENTANOATE • CETETH-2 • PEG-40 STEARATE • DIMETHICONE • CETEARYL ALCOHOL • PEG/PPG-18/18 DIMETHICONE • STEARETH-20 • BISABOLOL • MAGNESIUM ASCORBYL PHOSPHATE • POLYGLYCERYL-6 POLYRICINOLEATE • SORBITOL • PHYTOSPHINGOSINE • SODIUM STEARATE • MAGNESIUM ALUMINUM SILICATE • CAPRYLYL GLYCOL • ISOPROPYL TITANIUM TRIISOSTEARATE • STEARIC ACID • HEXYLENE GLYCOL • XANTHAN GUM • DISODIUM EDTA • PHENOXYETHANOL • IRON OXIDES (CI 77491, CI 77492, CI 77499) • CHROMIUM HYDROXIDE GREEN (CI 77289) [ILN36209]
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 40 ml Carton
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INGREDIENTS AND APPEARANCE
CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-722 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6.4 mL in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2 mL in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) butylene glycol (UNII: 3XUS85K0RA) alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ) steareth-2 (UNII: V56DFE46J5) tricaprylyl citrate (UNII: BXW1GAI4TA) silicon dioxide (UNII: ETJ7Z6XBU4) barium sulfate (UNII: 25BB7EKE2E) sorbitan tristearate (UNII: 6LUM696811) aluminum stearate (UNII: U6XF9NP8HM) ascophyllum nodosum (UNII: 168S4EO8YJ) asparagopsis armata (UNII: 2936KN6I1G) pseudopterogorgia elisabethae (UNII: UDY3H1OUX5) glyceryl monostearate (UNII: 230OU9XXE4) alpha-tocopherol acetate (UNII: 9E8X80D2L0) peg-100 stearate (UNII: YD01N1999R) sucrose (UNII: C151H8M554) pantethine (UNII: 7K81IL792L) caffeine (UNII: 3G6A5W338E) octyldodecyl neopentanoate (UNII: X8725R883T) ceteth-2 (UNII: 7H8VAM7778) peg-40 stearate (UNII: ECU18C66Q7) dimethicone (UNII: 92RU3N3Y1O) cetostearyl alcohol (UNII: 2DMT128M1S) steareth-20 (UNII: L0Q8IK9E08) levomenol (UNII: 24WE03BX2T) magnesium ascorbyl phosphate (UNII: 0R822556M5) sorbitol (UNII: 506T60A25R) sodium stearate (UNII: QU7E2XA9TG) magnesium aluminum silicate (UNII: 6M3P64V0NC) caprylyl glycol (UNII: 00YIU5438U) stearic acid (UNII: 4ELV7Z65AP) hexylene glycol (UNII: KEH0A3F75J) xanthan gum (UNII: TTV12P4NEE) edetate disodium (UNII: 7FLD91C86K) phenoxyethanol (UNII: HIE492ZZ3T) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-722-01 1 in 1 CARTON 1 40 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/01/2007 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
