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

Dosage form: cream
Ingredients: AVOBENZONE 3mL in 100mL, OCTINOXATE 7.5mL in 100mL, OCTISALATE 5mL in 100mL
Labeler: ESTEE LAUDER INC
NDC Code: 11559-021

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.

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

ADVANCED TIME ZONE AGE REVERSING   LINE WRINKLE BROAD SPECTRUM SPF 15 NORMAL COMBO SKIN
avobenzone, octinoxate, and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-021
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE3 mL  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water 
butylene glycol 
glycerin 
octyldodecyl myristate 
neopentyl glycol diheptanoate 
dimethicone 
glyceryl monostearate 
watermelon 
apple 
lens culinaris fruit 
centaurium erythraea 
laminaria digitata 
barley 
cucumber 
tamarind seed 
salicornia europaea 
polygonum cuspidatum root 
vitis vinifera seed 
rosemary 
selaginella tamariscina 
hops 
tangerine peel 
yeast 
limonium vulgare flowering top 
cetyl alcohol 
pentaerythrityl tetraethylhexanoate 
high density polyethylene 
pomegranate juice 
cholesterol 
sucrose 
linoleic acid 
caffeine 
n-acetylglucosamine 
linolenic acid 
adenosine phosphate 
acetyl hexapeptide-8 
glucose oxidase 
peg-100 stearate 
glyceryl trioleate 
phytantriol 
.alpha.-tocopherol acetate 
trehalose 
pentylene glycol 
docosanol 
medium-chain triglycerides 
isohexadecane 
caprylyl glycol 
propylene glycol dicaprate 
sodium pyrrolidone carboxylate 
helianthus annuus seedcake 
polysorbate 80 
dextrose 
hyaluronate sodium 
sodium lactate 
oleic acid 
palmitic acid 
stearic acid 
potassium sulfate 
decarboxy carnosine hydrochloride 
masoprocol 
hexylene glycol 
potassium hydroxide 
silicon dioxide 
edetate disodium 
butylated hydroxytoluene 
phenoxyethanol 
Packaging
#Item CodePackage Description
1NDC:11559-021-011 CONTAINER (CONTAINER) in 1 CARTON
150 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/01/2012
Labeler - ESTEE LAUDER INC (005914387)
Establishment
NameAddressID/FEIOperations
ELGC K.K.712808195RELABEL(11559-021), REPACK(11559-021)
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(11559-021), RELABEL(11559-021), REPACK(11559-021)
Establishment
NameAddressID/FEIOperations
Estee Lauder Inc.042918826MANUFACTURE(11559-021)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(11559-021), RELABEL(11559-021)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(11559-021)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(11559-021)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(11559-021)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326MANUFACTURE(11559-021)
Establishment
NameAddressID/FEIOperations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(11559-021)
Establishment
NameAddressID/FEIOperations
NORTEC KEYSTONE943871157MANUFACTURE(11559-021), RELABEL(11559-021), REPACK(11559-021)
Establishment
NameAddressID/FEIOperations
NORTHTEC BRISTOL959338336MANUFACTURE(11559-021), RELABEL(11559-021), REPACK(11559-021)
Establishment
NameAddressID/FEIOperations
NORTHTEC KEYSTONE949264774MANUFACTURE(11559-021), RELABEL(11559-021), REPACK(11559-021)
Establishment
NameAddressID/FEIOperations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(11559-021)
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058MANUFACTURE(11559-021)
Establishment
NameAddressID/FEIOperations
Pennsylvania Logistics Center078364654REPACK(11559-021), RELABEL(11559-021)

Revised: 09/2012
 
ESTEE LAUDER INC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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