Label: SUPER CITY BLOCK- zinc oxide, octinoxate, titanium dioxide, and octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49527-942-01 - 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 September 15, 2011
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- ACTIVE INGREDIENTS
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INGREDIENTS
WATER\AQUA\EAU • TRIOCTYLDODECYL CITRATE • BUTYLENE GLYCOL • DIMETHICONE • OCTYLDODECYL NEOPENTANOATE • STEARETH-2 • SILICA • ALUMINUM STEARATE • ROSA ROXBURGHII FRUIT EXTRACT • CITRUS UNSHIU PEEL EXTRACT • PORPHYRA YEZOENSIS (ALGAE) EXTRACT • GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT • SACCHAROMYCES LYSATE EXTRACT • CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT • BETULA ALBA (BIRCH) BARK EXTRACT • HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE • ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT • HELIANTHUS ANNULIS (SUNFLOWER) SEEDCAKE • GENTIANA LUTEA (GENTIAN) ROOT EXTRACT • YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE • SODIUM RNA • MAGNESIUM ASCORBYL PHOSPHATE • DIPOTASSIUM GLYCYRRHIZATE • TOCOPHERYL ACETATE • PANTETHINE • SQUALANE • POLYGLYCERYL-6 POLYRICINOLEATE • TRICAPRYLIN • PROPYLENE GLYCOL DICAPRATE • CHAMOMILLA RECUTTIA (MATRICARIA) • HEXYLENE GLYCOL • PEG/PPG-18/18 DIMETHICONE • CAPRYLYL GLYCOL • BARIUM SULFATE • POLYETHYLENE • XANTHAN GUM • MAGNESIUM ALUMINUM SILICATE • LECITHIN • CETETH-2 • PEG-40 STEARATE • SODIUM STEARATE • STEARETH-20 • SORBITAN TRISTEARATE • ISOPROPYL TITANIUM TRIISOSTEARATE • CITRIC ACID • DISODIUM EDTA • BHT • PHENOXYETHANOL • MICA • IRON OXIDES (CI 77491, CI 77492, CI77499) • TITANIUM DIOXIDE (CI 77891) [ILN38498]
- PRINCIPAL DISPLAY PANEL - 40 ml Carton
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INGREDIENTS AND APPEARANCE
SUPER CITY BLOCK SPF 40 OIL FREE DAILY FACE PROTECTOR
zinc oxide, octinoxate, titanium dioxide, and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-942 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z) zinc oxide 8.8 mL in 100 mL octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate 7.5 mL in 100 mL titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP) titanium dioxide 6.6 mL in 100 mL octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W) octisalate 2 mL in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) butylene glycol (UNII: 3XUS85K0RA) dimethicone (UNII: 92RU3N3Y1O) octyldodecyl neopentanoate (UNII: X8725R883T) steareth-2 (UNII: V56DFE46J5) silicon dioxide (UNII: ETJ7Z6XBU4) aluminum stearate (UNII: U6XF9NP8HM) angelica acutiloba root (UNII: 3W51R3EK30) jujube fruit (UNII: G55HNL2C70) rosa roxburghii fruit (UNII: CVT1AA87FF) tangerine peel (UNII: JU3D414057) porphyra yezoensis (UNII: D72A570T01) paeonia suffruticosa root (UNII: 7M7E9A2C8J) safflower (UNII: 4VBL71TY4Y) glycyrrhiza glabra (UNII: 2788Z9758H) paeonia lactiflora root (UNII: 3Z3866YW6P) saccharomyces lysate (UNII: R85W246Z1C) cucumber (UNII: YY7C30VXJT) betula pubescens bark (UNII: 3R504894L9) hordeum vulgare root (UNII: 790S39483Z) rosemary (UNII: IJ67X351P9) helianthus annuus seedcake (UNII: 482WYF7XLC) gentiana lutea root (UNII: S72O3284MS) yeast (UNII: 3NY3SM6B8U) magnesium ascorbyl phosphate (UNII: 0R822556M5) glycyrrhizinate dipotassium (UNII: CA2Y0FE3FX) pantethine (UNII: 7K81IL792L) glycerin (UNII: PDC6A3C0OX) dextrose (UNII: IY9XDZ35W2) squalane (UNII: GW89575KF9) tricaprylin (UNII: 6P92858988) propylene glycol dicaprate (UNII: U783H9JHWY) hexylene glycol (UNII: KEH0A3F75J) caprylyl glycol (UNII: 00YIU5438U) barium sulfate (UNII: 25BB7EKE2E) high density polyethylene (UNII: UG00KM4WR7) xanthan gum (UNII: TTV12P4NEE) magnesium aluminum silicate (UNII: 6M3P64V0NC) ceteth-2 (UNII: 7H8VAM7778) peg-40 stearate (UNII: ECU18C66Q7) sodium stearate (UNII: QU7E2XA9TG) steareth-20 (UNII: L0Q8IK9E08) sorbitan tristearate (UNII: 6LUM696811) citric acid monohydrate (UNII: 2968PHW8QP) edetate disodium (UNII: 7FLD91C86K) butylated hydroxytoluene (UNII: 1P9D0Z171K) phenoxyethanol (UNII: HIE492ZZ3T) mica (UNII: V8A1AW0880) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) fu ling (UNII: XH37TWY5O4) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHAMOMILE (UNII: FGL3685T2X) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-942-01 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 09/01/2004 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