![YOUTH SURGE (OCTISALATE, AVOBENZONE, OCTOCRYLENE, AND HOMOSALATE) CREAM [CLINIQUE LABORATORIES INC.]](https://medic.hrt.org//dailymed/images/cd7c35ae-7d43-4d1e-9b97-45e5c6cc5884/youth-surge-01.jpg)
| NDC | 49527-732-01 |
| Set ID | cd7c35ae-7d43-4d1e-9b97-45e5c6cc5884 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | CLINIQUE LABORATORIES INC. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- 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
