ADVANCED TIME ZONE AGE REVERSING  LINE WRINKLE BROAD SPECTRUM SPF 15 NORMAL COMBO 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 BROAD SPECTRUM SPF 15 NORMAL /COMBO SKIN

Drug Facts

Active ingredients Purpose
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:

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>

Other information

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

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

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
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)

Revised: 9/2012
Document Id: 2c8d36a1-5545-4ce8-b066-eb011dba96d0
Set id: 3169db90-4d1a-4c21-aafb-bf65161ee94c
Version: 1
Effective Time: 20120904
ESTEE LAUDER INC