Label: REPAIRWEAR LIFT SPF 15 FIRMING DAY DRY COMBO SKIN- octinoxate, octisalate, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49527-719-01, 49527-719-02 - 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 July 25, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
inactive ingredients: water [] neopentyl glycol diheptanoate [] cetyl alcohol [] glycerin [] polyethylene [] di-c12-15 alkyl fumarate [] petrolatum [] hydrogenated lecithin [] butylene glycol [] pentylene glycol [] isocetyl alcohol [] hydrogenated polyisobutene [] octyldodecyl myristate [] pentaerythrityl tetraethylhexanoate [] hexyldecyl stearate [] behenyl alcohol [] potato starch modified [] prunus amygdalus dulcis (sweet almond) seed extract [] olea europaea (olive) fruit extract [] coleus barbatus extract [] cucumis melo (melon) fruit extract [] saccharomyces lysate extract [] triticum vulgare (wheat bran) extract [] coffea robusta seed extract [] whey protein\lactis protein\protéine du petit-lait [] betula alba (birch) bark extract [] algae extract [] octyldodecyl neopentanoate [] persea gratissima (avocado) oil [] sigesbeckia orientalis (st. paul's wort) extract [] polygonum cuspidatum root extract [] thermus thermophillus ferment [] isomerized linoleic acid [] dimethicone [] c12-16 alcohols [] linoleic acid [] peg-100 stearate [] caprylyl glycol [] caffeine [] palmitic acid [] glycine soja (soybean) sterols [] aluminum stearate [] glyceryl stearate [] trehalose [] sodium rna [] creatine [] hexylene glycol [] sorbitol [] polysilicone-11 [] adenosine phosphate [] aminopropyl ascorbyl phosphate [] propylene glycol dicaprylate [] cholesterol/potassium sulfate [] ethylhexyl palmitate [] sodium hyaluronate [] decarboxy carnosine hcl [] cholesterol [] sodium dna [] astrocaryum murumuru seed butter [] ethylhexyl stearate [] phytosphingosine [] propylene glycol dicaprate [] acetyl hexapeptide-8 [] xanthan gum [] sodium stearate [] sodium carbomer [] sodium citrate [] disodium edta [] potassium sorbate [] phenoxyethanol
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REPAIRWEAR LIFT SPF 15 FIRMING DAY DRY COMBO SKIN
octinoxate, octisalate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-719 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3.5 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.0 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P) PETROLATUM (UNII: 4T6H12BN9U) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PENTYLENE GLYCOL (UNII: 50C1307PZG) ISOCETYL ALCOHOL (UNII: 1800H64066) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) OCTYLDODECYL MYRISTATE (UNII: S013N99GR8) DOCOSANOL (UNII: 9G1OE216XY) STARCH, POTATO (UNII: 8I089SAH3T) ALMOND (UNII: 3Z252A2K9G) OLIVE OIL (UNII: 6UYK2W1W1E) PLECTRANTHUS BARBATUS ROOT (UNII: V5741391RG) CUCUMBER (UNII: YY7C30VXJT) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) WHEAT GERM (UNII: YR3G369F5A) ROBUSTA COFFEE BEAN (UNII: V5032728L7) WHEY (UNII: 8617Z5FMF6) BETULA PUBESCENS BARK (UNII: 3R504894L9) SEAWEED (UNII: 477TV3P5UX) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) AVOCADO OIL (UNII: 6VNO72PFC1) POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7) LINOLEIC ACID (UNII: 9KJL21T0QJ) DIMETHICONE (UNII: 92RU3N3Y1O) C12-16 ALCOHOLS (UNII: S4827SZE3L) PEG-100 STEARATE (UNII: YD01N1999R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAFFEINE (UNII: 3G6A5W338E) PALMITIC ACID (UNII: 2V16EO95H1) ALUMINUM STEARATE (UNII: U6XF9NP8HM) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) TREHALOSE (UNII: B8WCK70T7I) CREATINE (UNII: MU72812GK0) HEXYLENE GLYCOL (UNII: KEH0A3F75J) SORBITOL (UNII: 506T60A25R) ADENOSINE PHOSPHATE (UNII: 415SHH325A) PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2) ETHYLHEXYL PALMITATE (UNII: 2865993309) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CHOLESTEROL (UNII: 97C5T2UQ7J) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY) ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM STEARATE (UNII: QU7E2XA9TG) SODIUM CITRATE (UNII: 1Q73Q2JULR) EDETATE DISODIUM (UNII: 7FLD91C86K) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-719-01 1 in 1 CARTON 1 NDC:49527-719-02 50 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/01/2007 Labeler - CLINIQUE LABORATORIES INC (173047747) 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 Aramis Inc. 042918826 manufacture 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 Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd. 255175580 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd 253616536 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 Kabushiki Kaisha 712808195 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