Label: ADVANCED TIME ZONE AGE REVERSING LINE/WRINKLE OIL FREE BROAD SPECTRUM SPF 15 NORMAL/COMBINATION 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 December 17, 2018

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 • octyldodecyl myristate • glycerin • neopentyl glycol diheptanoate • dimethicone • glyceryl stearate • polyethylene • hydrogenated lecithin • pentaerythrityl tetraethylhexanoate • whey protein\lactis protein\proteine du petit-lait • polygonum cuspidatum root extract • humulus lupulus (hops) extract • helianthus annuus (sunflower) seedcake • punica granatum (pomegranate) fruit juice • centaurium erythraea (centaury) extract • lens esculenta (lentil) fruit extract • pyrus malus (apple) fruit extract • hordeum vulgare (barley) extract\extrait d'orge • laminaria digitata extract • cucumis sativus (cucumber) fruit extract • laminaria saccharina extract • tamarindus indica seed extract • hydrolyzed rice extract • litchi chinensis seed extract • vitis vinifera (grape) seed extract • rosmarinus officinalis (rosemary) extract • selaginella tamariscina (spike moss) extract • rosmarinus officinalis (rosemary) leaf extract • citrus reticulata (tangerine) peel extract • limonium vulgare flower/leaf/stem extract • citrullus vulgaris (watermelon) fruite extract • sigesbeckia orientalis (st. paul's wort) extract • anthemis nobilis (chamomile) • yeast extract\faex\extrait de levure • linolenic acid • cholesterol • caffeine • sucrose • glucose • isohexadecane • chamomilla recutita (matricaria) • sodium pca • propylene glycol dicaprate • caprylyl glycol • acetyl glucosamine • trehalose • thermus thermophillus ferment • phytantriol • glucose oxidase • di-c12-15 alkyl fumarate • sodium hyaluronate • sodium lactate • linoleic acid • adenosine phosphate • peg-100 stearate • tocopheryl acetate • lactoperoxidase • decarboxy carnosine hcl • acetyl hexapeptide-8 • behenyl alcohol • pvp/hexadecene copolymer • pentylene glycol • hdi/ppg/polycaprolactone crosspolymer • acrylamide/sodium acryloyldimethyltaurate copolymer • polysilicone-11 • cetyl alcohol • carbomer • pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate • potassium hydroxide • polysorbate 80 • hexylene glycol • potassium sulfate • dextrin • lecithin • nordihydroguaiaretic acid • cyclodextrin • silica • ethylbisiminomethylguaiacol manganese chloride • disodium edta • phenoxyethanol <iln39640>

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  • Other information

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

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  • PRINCIPAL DISPLAY PANEL - 50 ml Container Carton

    EL

    ESTĒE LAUDER

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

    Normal/Combination Skin

    POIDS NET WT. 1.7 OZ./50 ml e

    Principal Display Panel - 50 ml Container Carton
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  • INGREDIENTS AND APPEARANCE
    ADVANCED TIME ZONE AGE REVERSING   LINE/WRINKLE OIL FREE BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN
    avobenzone, octinoxate, and octisalate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-035
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.03 g  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.075 g  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.05 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    butylene glycol (UNII: 3XUS85K0RA)  
    octyldodecyl myristate (UNII: S013N99GR8)  
    glycerin (UNII: PDC6A3C0OX)  
    neopentyl glycol diheptanoate (UNII: 5LKW3C543X)  
    dimethicone (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897)  
    REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)  
    HOPS (UNII: 01G73H6H83)  
    HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)  
    POMEGRANATE JUICE (UNII: 99S671U9KB)  
    CENTAURIUM ERYTHRAEA (UNII: 57X4TSH58S)  
    LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)  
    APPLE (UNII: B423VGH5S9)  
    BARLEY (UNII: 5PWM7YLI7R)  
    laminaria digitata (UNII: 15E7C67EE8)  
    CUCUMBER (UNII: YY7C30VXJT)  
    SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
    TAMARIND SEED (UNII: 6AHP8A7OML)  
    LITCHI CHINENSIS SEED (UNII: 9294024N9Q)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    ROSEMARY (UNII: IJ67X351P9)  
    TANGERINE PEEL (UNII: JU3D414057)  
    LIMONIUM VULGARE FLOWERING TOP (UNII: 840Y01ZC0M)  
    WATERMELON (UNII: 231473QB6R)  
    CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    linolenic acid (UNII: 0RBV727H71)  
    cholesterol (UNII: 97C5T2UQ7J)  
    caffeine (UNII: 3G6A5W338E)  
    sucrose (UNII: C151H8M554)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    isohexadecane (UNII: 918X1OUF1E)  
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    propylene glycol dicaprate (UNII: U783H9JHWY)  
    caprylyl glycol (UNII: 00YIU5438U)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    trehalose (UNII: B8WCK70T7I)  
    phytantriol (UNII: 8LVI07A72W)  
    glucose oxidase (UNII: 0T8392U5N1)  
    di-c12-15 alkyl fumarate (UNII: A1CB3Z898P)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    sodium lactate (UNII: TU7HW0W0QT)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    adenosine phosphate (UNII: 415SHH325A)  
    peg-100 stearate (UNII: YD01N1999R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DECARBOXY CARNOSINE HYDROCHLORIDE (UNII: 6X7K9I5QR7)  
    acetyl hexapeptide-8 (UNII: L4EL31FWIL)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    pentylene glycol (UNII: 50C1307PZG)  
    cetyl alcohol (UNII: 936JST6JCN)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    potassium hydroxide (UNII: WZH3C48M4T)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    hexylene glycol (UNII: KEH0A3F75J)  
    potassium sulfate (UNII: 1K573LC5TV)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    MASOPROCOL (UNII: 7BO8G1BYQU)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ethylbisiminomethylguaiacol manganese chloride (UNII: SM5YJ88LTU)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11559-035-01 1 in 1 CARTON 05/01/2013
    1 50 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 05/01/2013
    Labeler - ESTEE LAUDER INC (005914387)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COMPANY, THE 828534516 RELABEL(11559-035) , REPACK(11559-035)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(11559-035)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD. 202952982 MANUFACTURE(11559-035)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER N.V. 370151326 MANUFACTURE(11559-035)
    Establishment
    Name Address ID/FEI Business Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(11559-035)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC INC 943871157 RELABEL(11559-035) , REPACK(11559-035)
    Establishment
    Name Address ID/FEI Business Operations
    PADC 1 949264774 RELABEL(11559-035) , REPACK(11559-035)
    Establishment
    Name Address ID/FEI Business Operations
    WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(11559-035)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(11559-035)
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