ADVANCED TIME ZONE AGE REVERSING LINE WRINKLE BROAD SPECTRUM SPF 15 DRY SKIN- avobenzone, octisalate, and octocrylene cream

ADVANCED TIME ZONE AGE REVERSING by

Drug Labeling and Warnings

ADVANCED TIME ZONE AGE REVERSING by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, ELGC K.K., Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), Estee Lauder Inc., ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation, Pennsylvania Logistics Center. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3.00%	Sunscreen
Octisalate 5.00%	Sunscreen
Octocrylene 2.70%	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 dimethicone butyrospermum parkii (shea butter) butylene glycol di-c12-15 alkyl fumarate steareth-21 pentaerythrityl tetraethylhexanoate sucrose cetyl alcohol glycerin neopentyl glycol diethylhexanoate hdi/ppg/polycaprolactone crosspolymer steareth-2 acrylamide/sodium acryloyldimethyltaurate copolymer polyethylene 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 punica granatum (pomegranate) fruit juice cholesterol linoleic acid caffeine acetyl glucosamine linolenic acid adenosine phosphate lactoperoxidase phospholipids acetyl hexapeptide-8 glucose oxidase tocopheryl acetate triolein cetyl dimethicone phytantriol trehalose ppg-15 stearyl ether pvp/hexadecene copolymer caprylic/capric triglyceride ethylhexylglycerin polysilicone-11 isohexadecane caprylyl glycol propylene glycol dicaprate sodium pca helianthus annuus (sunflower) seedcake propylene glycol heptanoate polysorbate 80 acrylates/c10-30 alkyl acrylate crosspolymer glucose neopentyl glycol diisostearate sodium hyaluronate sodium lactate phytosteryl canola glycerides oleic acid palmitic acid stearic acid potassium sulfate decarboxy carnosine hcl nordihydroguaiaretic acid cyclodextrin tromethamine hexylene glycol fragrance (parfum) silica ethylbisiminomethylguaiacol manganese chloride dipentaerythrityl tri-polyhydroxystearate disodium edta bht phenoxyethanol mica <iln38907>

Other information

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

SPL UNCLASSIFIED SECTION

ESTEĒ 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

Dry Skin

POIDS NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

ADVANCED TIME ZONE AGE REVERSING   LINE WRINKLE BROAD SPECTRUM SPF 15 DRY SKIN
avobenzone, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-020
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
shea butter (UNII: K49155WL9Y)
butylene glycol (UNII: 3XUS85K0RA)
di-c12-15 alkyl fumarate (UNII: A1CB3Z898P)
steareth-21 (UNII: 53J3F32P58)
pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897)
sucrose (UNII: C151H8M554)
cetyl alcohol (UNII: 936JST6JCN)
glycerin (UNII: PDC6A3C0OX)
neopentyl glycol diethylhexanoate (UNII: U68ZV6W62C)
steareth-2 (UNII: V56DFE46J5)
high density polyethylene (UNII: UG00KM4WR7)
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)
pomegranate juice (UNII: 99S671U9KB)
cholesterol (UNII: 97C5T2UQ7J)
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)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
glyceryl trioleate (UNII: O05EC62663)
phytantriol (UNII: 8LVI07A72W)
trehalose (UNII: B8WCK70T7I)
ppg-15 stearyl ether (UNII: 1II18XLS1L)
isohexadecane (UNII: 918X1OUF1E)
medium-chain triglycerides (UNII: C9H2L21V7U)
ethylhexylglycerin (UNII: 147D247K3P)
caprylyl glycol (UNII: 00YIU5438U)
helianthus annuus seedcake (UNII: 482WYF7XLC)
propylene glycol dicaprate (UNII: U783H9JHWY)
propylene glycol heptanoate (UNII: 25DEK56Z7Z)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
dextrose (UNII: IY9XDZ35W2)
neopentyl glycol diisostearate (UNII: 4M6OQ34JWW)
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)
tromethamine (UNII: 023C2WHX2V)
hexylene glycol (UNII: KEH0A3F75J)
silicon dioxide (UNII: ETJ7Z6XBU4)
edetate disodium (UNII: 7FLD91C86K)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-020-01	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(11559-020) , REPACK(11559-020)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(11559-020) , RELABEL(11559-020) , REPACK(11559-020)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc.		042918826	MANUFACTURE(11559-020)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(11559-020) , RELABEL(11559-020)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(11559-020)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-020)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(11559-020)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-020)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-020)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(11559-020) , RELABEL(11559-020) , REPACK(11559-020)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(11559-020) , RELABEL(11559-020) , REPACK(11559-020)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(11559-020) , RELABEL(11559-020) , REPACK(11559-020)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-020)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(11559-020)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(11559-020) , RELABEL(11559-020)