ADVANCED TIME ZONE AGE REVERSING  LINE/WRINKLE OIL FREE BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN- avobenzone, octinoxate, and octisalate cream 
ESTEE LAUDER INC

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.

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ADVANCED TIME ZONE AGE REVERSING
LINE/WRINKLE CRÈME OIL FREE BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN

Drug Facts

Active ingredientsPurpose
Avobenzone 3.00%Sunscreen
Octinoxate 7.50%Sunscreen
Octisalate 5.00%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\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>

Other information

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

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
ADVANCED TIME ZONE AGE REVERSING   LINE/WRINKLE OIL FREE BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN
avobenzone, octinoxate, and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 g  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11559-035-011 in 1 CARTON05/01/2013
150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/01/201311/19/2020
Labeler - ESTEE LAUDER INC (005914387)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COMPANY, THE828534516RELABEL(11559-035) , REPACK(11559-035)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(11559-035)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.202952982MANUFACTURE(11559-035)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(11559-035)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(11559-035)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC INC943871157RELABEL(11559-035) , REPACK(11559-035)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774RELABEL(11559-035) , REPACK(11559-035)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(11559-035)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(11559-035)

Revised: 12/2018
 
ESTEE LAUDER INC