Label: ADVANCED TIME ZONE AGE REVERSING LINE WRINKLE BROAD SPECTRUM SPF 15 NORMAL COMBO SKIN- avobenzone, octinoxate, and octisalate cream

  • 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 September 4, 2012

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Avobenzone 3.00% Sunscreen
    Octinoxate 7.50% Sunscreen
    Octisalate 5.00% Sunscreen
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  • Use

    helps prevent sunburn

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  • 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.

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  • 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
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  • Inactive ingredients

    water\aqua\eau • butylene glycol • glycerin • octyldodecyl myristate • neopentyl glycol diheptanoate • dimethicone • glyceryl stearate • citrullus vulgaris (watermelon) fruit extract • sigesbeckia orientalis (st. paul's wort) extract • pyrus malus (apple) fruit extract • lens esculenta (lentil) fruit extract • centaurium erythraea (centaury) extract • laminaria digitata extract • hordeum vulgare (barley) extract\extrait d'orge • cucumis sativus (cucumber) fruit extract • tamarindus indica seed extract • salicornia herbacea extract • polygonum cuspidatum root extract • vitis vinifera (grape) seed extract • hydrolyzed rice extract • rosmarinus officinalis (rosemary) extract • selaginella tamariscina (spike moss) extract • humulus lupulus (hops) extract • citrus reticulata (tangerine) peel extract • yeast extract\faex\extrait de levure • limonium vulgare flower/leaf/stem extract • whey protein\lactis protein\proteine du petit-lait • thermus thermophillus ferment • cetyl alcohol • pentaerythrityl tetraethylhexanoate • hydrogenated lecithin • polyethylene • caprylic/capric/myristic/stearic triglyceride • punica granatum (pomegranate) fruit juice • cholesterol • sucrose • linoleic acid • caffeine • acetyl glucosamine • linolenic acid • adenosine phosphate • lactoperoxidase • phospholipids • acetyl hexapeptide-8 • glucose oxidase • peg-100 stearate • acrylamide/sodium acryloyldimethyltaurate copolymer • tocopheryl acetate • triolein • behenyl alcohol • phytantriol • trehalose • pvp/hexadecene copolymer • pentylene glycol • hdi/ppg/polycaprolactone crosspolymer • caprylic/capric triglyceride • polysilicone-11 • isohexadecane • caprylyl glycol • propylene glycol dicaprate • sodium pca • helianthus annuus (sunflower) seedcake • polysorbate 80 • glucose • sodium hyaluronate • sodium lactate • phytosteryl canola glycerides • oleic acid • palmitic acid • stearic acid • potassium sulfate • decarboxy carnosine hcl • nordihydroguaiaretic acid • cyclodextrin • carbomer • hexylene glycol • potassium hydroxide • fragrance (parfum) • silica • ethylbisiminomethylguaicol manganese chloride • disodium edta • bht • phenoxyethanol <iln38899>

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  • Other information

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

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  • SPL UNCLASSIFIED SECTION

    ESTĒE LAUDER, DIST., NEW YORK, N.Y. 10022

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  • PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

    EL

    ESTĒE LAUDER

    Advanced Time Zone
    Age Reversing Line/Wrinkle Creme
    Broad Spectrum SPF 15

    Normal/Combination Skin

    POIDS NET WT. 1.7 OZ./50 ml e

    PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
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  • INGREDIENTS AND APPEARANCE
    ADVANCED TIME ZONE AGE REVERSING   LINE WRINKLE BROAD SPECTRUM SPF 15 NORMAL COMBO SKIN
    avobenzone, octinoxate, and octisalate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-021
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mL  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    butylene glycol (UNII: 3XUS85K0RA)  
    glycerin (UNII: PDC6A3C0OX)  
    octyldodecyl myristate (UNII: S013N99GR8)  
    neopentyl glycol diheptanoate (UNII: 5LKW3C543X)  
    dimethicone (UNII: 92RU3N3Y1O)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    watermelon (UNII: 231473QB6R)  
    apple (UNII: B423VGH5S9)  
    lens culinaris fruit (UNII: ZYZ076G9JH)  
    centaurium erythraea (UNII: 57X4TSH58S)  
    laminaria digitata (UNII: 15E7C67EE8)  
    barley (UNII: 5PWM7YLI7R)  
    cucumber (UNII: YY7C30VXJT)  
    tamarind seed (UNII: 6AHP8A7OML)  
    salicornia europaea (UNII: 6ADL50JAKW)  
    polygonum cuspidatum root (UNII: 7TRV45YZF7)  
    vitis vinifera seed (UNII: C34U15ICXA)  
    rosemary (UNII: IJ67X351P9)  
    selaginella tamariscina (UNII: GP370KXK6M)  
    hops (UNII: 01G73H6H83)  
    tangerine peel (UNII: JU3D414057)  
    yeast (UNII: 3NY3SM6B8U)  
    limonium vulgare flowering top (UNII: 840Y01ZC0M)  
    cetyl alcohol (UNII: 936JST6JCN)  
    pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897)  
    high density polyethylene (UNII: UG00KM4WR7)  
    pomegranate juice (UNII: 99S671U9KB)  
    cholesterol (UNII: 97C5T2UQ7J)  
    sucrose (UNII: C151H8M554)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    caffeine (UNII: 3G6A5W338E)  
    n-acetylglucosamine (UNII: V956696549)  
    linolenic acid (UNII: 0RBV727H71)  
    adenosine phosphate (UNII: 415SHH325A)  
    acetyl hexapeptide-8 (UNII: L4EL31FWIL)  
    glucose oxidase (UNII: 0T8392U5N1)  
    peg-100 stearate (UNII: YD01N1999R)  
    glyceryl trioleate (UNII: O05EC62663)  
    phytantriol (UNII: 8LVI07A72W)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    trehalose (UNII: B8WCK70T7I)  
    pentylene glycol (UNII: 50C1307PZG)  
    docosanol (UNII: 9G1OE216XY)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    isohexadecane (UNII: 918X1OUF1E)  
    caprylyl glycol (UNII: 00YIU5438U)  
    propylene glycol dicaprate (UNII: U783H9JHWY)  
    sodium pyrrolidone carboxylate (UNII: 469OTG57A2)  
    helianthus annuus seedcake (UNII: 482WYF7XLC)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    dextrose (UNII: IY9XDZ35W2)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    sodium lactate (UNII: TU7HW0W0QT)  
    oleic acid (UNII: 2UMI9U37CP)  
    palmitic acid (UNII: 2V16EO95H1)  
    stearic acid (UNII: 4ELV7Z65AP)  
    potassium sulfate (UNII: 1K573LC5TV)  
    decarboxy carnosine hydrochloride (UNII: 6X7K9I5QR7)  
    masoprocol (UNII: 7BO8G1BYQU)  
    hexylene glycol (UNII: KEH0A3F75J)  
    potassium hydroxide (UNII: WZH3C48M4T)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    edetate disodium (UNII: 7FLD91C86K)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11559-021-01 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 06/01/2012
    Labeler - ESTEE LAUDER INC (005914387)
    Establishment
    Name Address ID/FEI Business Operations
    ELGC K.K. 712808195 RELABEL(11559-021) , REPACK(11559-021)
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(11559-021) , RELABEL(11559-021) , REPACK(11559-021)
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Inc. 042918826 MANUFACTURE(11559-021)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(11559-021) , RELABEL(11559-021)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(11559-021)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(11559-021)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(11559-021)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER N.V. 370151326 MANUFACTURE(11559-021)
    Establishment
    Name Address ID/FEI Business Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(11559-021)
    Establishment
    Name Address ID/FEI Business Operations
    NORTEC KEYSTONE 943871157 MANUFACTURE(11559-021) , RELABEL(11559-021) , REPACK(11559-021)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC BRISTOL 959338336 MANUFACTURE(11559-021) , RELABEL(11559-021) , REPACK(11559-021)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC KEYSTONE 949264774 MANUFACTURE(11559-021) , RELABEL(11559-021) , REPACK(11559-021)
    Establishment
    Name Address ID/FEI Business Operations
    WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(11559-021)
    Establishment
    Name Address ID/FEI Business Operations
    Aveda Corporation 071352058 MANUFACTURE(11559-021)
    Establishment
    Name Address ID/FEI Business Operations
    Pennsylvania Logistics Center 078364654 REPACK(11559-021) , RELABEL(11559-021)
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