Label: CLINIQUE SKIN SUPPLIES FOR MEN- octinoxate, octisalate, avobenzone, and oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 49527-886-01 - 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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- WARNING
- ACTIVE INGREDIENTS
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INGREDIENTS
WATER • BUTYLENE GLYCOL • DIMETHICONE • NEOPENTYL GLYCOL DIHEPTANOATE • CETEARYL ALCOHOL • SILICA • PEG-100 STEARATE • LACTOBACILLUS FERMENT • HORDEUM VULGARE (BARLEY) EXTRACT • ALGAE EXTRACT • CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT • HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE • CHOLESTEROL • CETEARYL GLUCOSIDE • PROPYLENE GLYCOL DICAPRATE • CHAMOMILLA RECUTITA (MATRICARIA) • TRIDECYL TRIMELLITATE • HYDROGENATED LECITHIN • STEARYL ALCOHOL • ZEOLITE • TRIDECYL STEARATE • ISODODECANE • DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE • PVP • OLETH-10 • LAURETH-4 • LAURETH-23 • CAPRYLYL GLYCOL • HEXYLENE GLYCOL • POLYETHYLENE • TROMETHAMINE • CARBOMER • SODIUM CITRATE • DISODIUM EDTA • SODIUM BENZOATE • POTASSIUM SORBATE • CHLORPHENESIN • PHENOXYETHANOL • YELLOW 5 (CI 19140) • YELLOW 6 (CI 15985) • RED 33 (CI 17200) [ILN29625]
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
CLINIQUE SKIN SUPPLIES FOR MEN
octinoxate, octisalate, avobenzone, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-886 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate 7.4 mL in 100 mL octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W) octisalate 5 mL in 100 mL avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX) avobenzone 3 mL in 100 mL oxybenzone (UNII: 95OOS7VE0Y) (oxybenzone - UNII:95OOS7VE0Y) oxybenzone 2 mL in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) butylene glycol (UNII: 3XUS85K0RA) dimethicone (UNII: 92RU3N3Y1O) neopentyl glycol diheptanoate (UNII: 5LKW3C543X) cetostearyl alcohol (UNII: 2DMT128M1S) silicon dioxide (UNII: ETJ7Z6XBU4) peg-100 stearate (UNII: YD01N1999R) barley (UNII: 5PWM7YLI7R) cucumber (UNII: YY7C30VXJT) helianthus annuus seedcake (UNII: 482WYF7XLC) cholesterol (UNII: 97C5T2UQ7J) cetearyl glucoside (UNII: 09FUA47KNA) propylene glycol dicaprate (UNII: U783H9JHWY) matricaria recutita (UNII: G0R4UBI2ZZ) tridecyl trimellitate (UNII: FY36J270ES) stearyl alcohol (UNII: 2KR89I4H1Y) tridecyl stearate (UNII: A8OE252M6L) isododecane (UNII: A8289P68Y2) dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW) oleth-10 (UNII: JD797EF70J) laureth-4 (UNII: 6HQ855798J) laureth-23 (UNII: N72LMW566G) caprylyl glycol (UNII: 00YIU5438U) hexylene glycol (UNII: KEH0A3F75J) high density polyethylene (UNII: UG00KM4WR7) tromethamine (UNII: 023C2WHX2V) sodium citrate (UNII: 1Q73Q2JULR) edetate disodium (UNII: 7FLD91C86K) sodium benzoate (UNII: OJ245FE5EU) potassium sorbate (UNII: 1VPU26JZZ4) chlorphenesin (UNII: I670DAL4SZ) phenoxyethanol (UNII: HIE492ZZ3T) fd&c yellow no. 5 (UNII: I753WB2F1M) fd&c yellow no. 6 (UNII: H77VEI93A8) d&c red no. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-886-01 1 in 1 CARTON 1 100 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
