Label: YOUTH SURGE SPF 15 AGE DECELERATING MOISTURIZER ANTI RIDES HYDRATANT- octinoxate and titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated November 18, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octinoxate 7.5%

    Titanium dioxide 1.4%

  • Purpose

    Sunscreen

  • Use

    helps prevent sunburn

  • Warnings

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • reapply at least every two hours
    • use a water resistant sunscreen if swimming or sweating
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. – 2 p.m.
      • wear long-sleeved shirts, pants, hats and sunglasses
    • children under 6 months of age: ask a doctor
  • Inactive ingredients

    water • cetyl ethylhexanoate • butylene glycol • octyldodecyl neopentanoate • glyceryl stearate • peg-100 stearate • glycerin • olea europaea (olive) fruit extract • coleus barbatus extract • sigesbeckia orientalis (st. paul's wort) extract • triticum vulgare (wheat bran) extract • polygonum cuspidatum root extract • saccharomyces lysate extract • algae extract • hydrolyzed rice extract • betula alba (birch) bark extract • padina pavonica thallus extract • coffea robusta seed extract • astrocaryum murumuru seed butter • citrus reticulata (tangerine) peel extract • laurdimonium hydroxypropyl hydrolyzed soy protein • hydrogenated lecithin • creatine • ethylhexyl palmitate • polyethylene • pentylene glycol • caffeine • behenyl alcohol • linoleic acid • cetyl alcohol • isoniacinamide • cholesterol • lecithin • sorbitol • trehalose • silica • sodium rna • dipalmitoyl hydroxyproline • disodium nadh • sodium hyaluronate • aminopropyl ascorbyl phosphate • methicone • caprylyl glycol • decarboxy carnosine hcl • potassium sulfate • adenosine phosphate • ethylhexyl stearate • glycine • phytosphingosine • acrylates copolymer • propylene glycol dicaprate • acetyl hexapeptide-8 • hydroxyproline • proline • xanthan gum • alumina • sodium dna • potassium hydroxide • hexylene glycol • carbomer • disodium edta • phenoxyethanol • potassium sorbate [iln36979]

  • Other information

    protect the product in this container from excessive heat and direct sun

  • SPL UNCLASSIFIED SECTION

    © CLINIQUE LABORATORIES, DIST. NEW YORK, N.Y. 10022

  • PRINCIPAL DISPLAY PANEL - 50 ml Carton

    C
    CLINIQUE

    youth surge
    age decelerating moisturizer
    broad spectrum SPF 15

    COMBINATION OILY TO OILY

    POIDS NET WT. 1.7 OZ./50 ml e

    Principal Display Panel - 50 ml Carton
  • INGREDIENTS AND APPEARANCE
    YOUTH SURGE   SPF 15 AGE DECELERATING MOISTURIZER ANTI RIDES HYDRATANT
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-731
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.4 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BLACK OLIVE (UNII: 2M6QWV94OC)  
    PLECTRANTHUS BARBATUS ROOT (UNII: V5741391RG)  
    WHEAT BRAN (UNII: 6L966A1IMR)  
    POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    BETULA PUBESCENS BARK (UNII: 3R504894L9)  
    PADINA PAVONICA (UNII: 177U06NHZI)  
    ROBUSTA COFFEE BEAN (UNII: V5032728L7)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    TANGERINE PEEL (UNII: JU3D414057)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    CREATINE (UNII: MU72812GK0)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CAFFEINE (UNII: 3G6A5W338E)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISONIACINAMIDE (UNII: 4H3BH6YX9Q)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    SORBITOL (UNII: 506T60A25R)  
    PIMAGEDINE HYDROCHLORIDE (UNII: A2Z7G2RGAH)  
    TREHALOSE (UNII: B8WCK70T7I)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POTASSIUM SULFATE (UNII: 1K573LC5TV)  
    ADENOSINE PHOSPHATE (UNII: 415SHH325A)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    GLYCINE (UNII: TE7660XO1C)  
    PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)  
    HYDROXYPROLINE (UNII: RMB44WO89X)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-731-011 in 1 CARTON
    150 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35202/24/2009
    Labeler - CLINIQUE LABORATORIES INC. (173047747)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELGC Kabushiki Kaisha712808195RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE, RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    ARAMIS, INC042918826MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK, RELABEL
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTEC KEYSTONE787336577MANUFACTURE, RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC BRISTOL949264774MANUFACTURE, RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC KEYSTONE618107429MANUFACTURE, RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    WHITMAN LABORATORIES, LTD.216866277MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058MANUFACTURE