Label: YOUTH SURGE- octisalate, avobenzone, octocrylene, and homosalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49527-732-01 - 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 5, 2011
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- WARNING
- ACTIVE INGREDIENTS
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INGREDIENTS
WATER • BEHENYL ALCOHOL • BUTYLENE GLYCOL • GLYCERIN • BUTYLOCTYL SALICYLATE • POLYGLYCERYL-2 TRIISOSTEARATE • DIMETHICONE • MYRISTYL MYRISTATE • PETROLATUM • CETYL ESTERS • PEG-100 STEARATE • POLYGONUM CUSPIDATUM ROOT EXTRACT • TRITICUM VULGARE (WHEAT BRAN) EXTRACT • SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT • OLEA EUROPAEA (OLIVE) FRUIT EXTRACT • COLEUS BARBATUS EXTRACT • SACCHAROMYCES LYSATE EXTRACT • HYDROLYZED RICE EXTRACT • ALGAE EXTRACT • PADINA PAVONICA THALLUS EXTRACT • ASTROCARYUM MURUMURU SEED BUTTER • COFFEA ROBUSTA SEED EXTRACT • BETULA ALBA (BIRCH) BARK EXTRACT • CITRUS RETICULATA (TANGERINE) PEEL EXTRACT • LAURDIMONIUM HYDROXYPROPYL HYDROLYZED SOY PROTEIN • CAFFEINE • CREATINE • LINOLEIC ACID • ADENOSINE PHOSPHATE • HYDROXYPROLINE • DECARBOXY CARNOSINE HCL • BETAINE • STEARETH-21 • ETHYLHEXYL PALMITATE • GLYCERYL STEARATE • CHOLESTEROL • TOCOPHERYL ACETATE • DI-PPG-2 MYRETH-10 ADIPATE • ISONICOTINAMIDE • SUCROSE • POLYETHYLENE • ISOHEXADECANE • TREHALOSE • SODIUM RNA • SODIUM DNA • DIPALMITOYL HYDROXYPROLINE • ACETYL HEXAPEPTIDE-8 • AMINOGUANIDINE HCL • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • DISODIUM NADH • POLYSORBATE 80 • TROMETHAMINE • AMINOPROPYL ASCORBYL PHOSPHATE • CAPRYLYL GLYCOL • LECITHIN • MAGNESIUM ASCORBYL PHOSPHATE • SODIUM HYALURONATE • PROLINE • ACRYLATES COPOLYMER • ETHYLHEXYL STEARATE • PHYTOSPHINGOSINE • GLYCINE • ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER • PROPYLENE GLYCOL DICAPRATE • HEXYLENE GLYCOL • CARBOMER • POTASSIUM SULFATE • XANTHAN GUM • POLYAMINOPROPYL BIGUANIDE • PHENOXYETHANOL • DISODIUM EDTA [ILN35043]
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Carton
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INGREDIENTS AND APPEARANCE
YOUTH SURGE AGE DECELERATING MOISTURIZER SPF 15
octisalate, avobenzone, octocrylene, and homosalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-732 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 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 homosalate (UNII: V06SV4M95S) (homosalate - UNII:V06SV4M95S) homosalate 2 mL in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) butylene glycol (UNII: 3XUS85K0RA) glycerin (UNII: PDC6A3C0OX) butyloctyl salicylate (UNII: 2EH13UN8D3) dimethicone (UNII: 92RU3N3Y1O) docosanol (UNII: 9G1OE216XY) myristyl myristate (UNII: 4042ZC00DY) petrolatum (UNII: 4T6H12BN9U) cetyl esters wax (UNII: D072FFP9GU) peg-100 stearate (UNII: YD01N1999R) polygonum cuspidatum root (UNII: 7TRV45YZF7) wheat bran (UNII: 6L966A1IMR) black olive (UNII: 2M6QWV94OC) plectranthus barbatus root (UNII: V5741391RG) saccharomyces lysate (UNII: R85W246Z1C) astrocaryum murumuru seed butter (UNII: 12V64UPU6R) robusta coffee bean (UNII: V5032728L7) betula pubescens bark (UNII: 3R504894L9) tangerine peel (UNII: JU3D414057) caffeine (UNII: 3G6A5W338E) creatine (UNII: MU72812GK0) linoleic acid (UNII: 9KJL21T0QJ) adenosine phosphate (UNII: 415SHH325A) hydroxyproline (UNII: RMB44WO89X) betaine (UNII: 3SCV180C9W) steareth-21 (UNII: 53J3F32P58) ethylhexyl palmitate (UNII: 2865993309) glyceryl monostearate (UNII: 230OU9XXE4) cholesterol (UNII: 97C5T2UQ7J) alpha-tocopherol acetate (UNII: 9E8X80D2L0) sucrose (UNII: C151H8M554) high density polyethylene (UNII: UG00KM4WR7) isohexadecane (UNII: 918X1OUF1E) trehalose (UNII: B8WCK70T7I) dipalmitoyl hydroxyproline (UNII: E6AHA53N1H) Pimagedine Hydrochloride (UNII: A2Z7G2RGAH) polysorbate 80 (UNII: 6OZP39ZG8H) tromethamine (UNII: 023C2WHX2V) caprylyl glycol (UNII: 00YIU5438U) magnesium ascorbyl phosphate (UNII: 0R822556M5) hyaluronate sodium (UNII: YSE9PPT4TH) proline (UNII: 9DLQ4CIU6V) ethylhexyl stearate (UNII: EG3PA2K3K5) glycine (UNII: TE7660XO1C) propylene glycol dicaprate (UNII: U783H9JHWY) hexylene glycol (UNII: KEH0A3F75J) potassium sulfate (UNII: 1K573LC5TV) xanthan gum (UNII: TTV12P4NEE) edetate disodium (UNII: 7FLD91C86K) polyaminopropyl biguanide (UNII: 322U039GMF) phenoxyethanol (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-732-01 1 in 1 CARTON 1 50 mL in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/01/2008 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
