YOUTH SURGE- octisalate, avobenzone, octocrylene, and homosalate cream

YOUTH SURGE by

Drug Labeling and Warnings

YOUTH SURGE by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES INC., ELGC Kabushiki Kaisha, Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ARAMIS, 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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNING

Keep out of eyes.

Stop use if irritation occurs.

Keep out of reach of children.

ACTIVE INGREDIENTS

OCTISALATE 5.0% AVOBENZONE 3.0% OCTOCRYLENE 2.7% HOMOSALATE 2.0%.

INGREDIENTS

WATER BEHENYL ALCOHOL BUTYLENE GLYCOL GLYCERIN BUTYLOCTYL SALICYLATE POLYGLYCERYL-2 TRIISOSTEARATE DIMETHICONE MYRISTYL MYRISTATE PETROLATUM CETYL ESTERS PEG-100 STEARATE POLYGONUM CUSPIDATUM ROOT EXTRACT TRITICUM VULGARE (WHEAT BRAN) EXTRACT SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT OLEA EUROPAEA (OLIVE) FRUIT EXTRACT COLEUS BARBATUS EXTRACT SACCHAROMYCES LYSATE EXTRACT HYDROLYZED RICE EXTRACT ALGAE EXTRACT PADINA PAVONICA THALLUS EXTRACT ASTROCARYUM MURUMURU SEED BUTTER COFFEA ROBUSTA SEED EXTRACT BETULA ALBA (BIRCH) BARK EXTRACT CITRUS RETICULATA (TANGERINE) PEEL EXTRACT LAURDIMONIUM HYDROXYPROPYL HYDROLYZED SOY PROTEIN CAFFEINE CREATINE LINOLEIC ACID ADENOSINE PHOSPHATE HYDROXYPROLINE DECARBOXY CARNOSINE HCL BETAINE STEARETH-21 ETHYLHEXYL PALMITATE GLYCERYL STEARATE CHOLESTEROL TOCOPHERYL ACETATE DI-PPG-2 MYRETH-10 ADIPATE ISONICOTINAMIDE SUCROSE POLYETHYLENE ISOHEXADECANE TREHALOSE SODIUM RNA SODIUM DNA DIPALMITOYL HYDROXYPROLINE ACETYL HEXAPEPTIDE-8 AMINOGUANIDINE HCL LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE DISODIUM NADH POLYSORBATE 80 TROMETHAMINE AMINOPROPYL ASCORBYL PHOSPHATE CAPRYLYL GLYCOL LECITHIN MAGNESIUM ASCORBYL PHOSPHATE SODIUM HYALURONATE PROLINE ACRYLATES COPOLYMER ETHYLHEXYL STEARATE PHYTOSPHINGOSINE GLYCINE ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER PROPYLENE GLYCOL DICAPRATE HEXYLENE GLYCOL CARBOMER POTASSIUM SULFATE XANTHAN GUM POLYAMINOPROPYL BIGUANIDE PHENOXYETHANOL DISODIUM EDTA [ILN35043]

SPL UNCLASSIFIED SECTION

© CLINIQUE LABORATORIES, DIST. NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 50 ml Carton

C

CLINIQUE

youth surge SPF 15

age decelerating moisturizer

VERY DRY TO DRY

NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

YOUTH SURGE   AGE DECELERATING MOISTURIZER SPF 15
octisalate, avobenzone, octocrylene, and homosalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-732
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W)	octisalate	5 mL  in 100 mL
avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX)	avobenzone	3 mL  in 100 mL
octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM)	octocrylene	2.7 mL  in 100 mL
homosalate (UNII: V06SV4M95S) (homosalate - UNII:V06SV4M95S)	homosalate	2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
butylene glycol (UNII: 3XUS85K0RA)
glycerin (UNII: PDC6A3C0OX)
butyloctyl salicylate (UNII: 2EH13UN8D3)
dimethicone (UNII: 92RU3N3Y1O)
docosanol (UNII: 9G1OE216XY)
myristyl myristate (UNII: 4042ZC00DY)
petrolatum (UNII: 4T6H12BN9U)
cetyl esters wax (UNII: D072FFP9GU)
peg-100 stearate (UNII: YD01N1999R)
polygonum cuspidatum root (UNII: 7TRV45YZF7)
wheat bran (UNII: 6L966A1IMR)
black olive (UNII: 2M6QWV94OC)
plectranthus barbatus root (UNII: V5741391RG)
saccharomyces lysate (UNII: R85W246Z1C)
astrocaryum murumuru seed butter (UNII: 12V64UPU6R)
robusta coffee bean (UNII: V5032728L7)
betula pubescens bark (UNII: 3R504894L9)
tangerine peel (UNII: JU3D414057)
caffeine (UNII: 3G6A5W338E)
creatine (UNII: MU72812GK0)
linoleic acid (UNII: 9KJL21T0QJ)
adenosine phosphate (UNII: 415SHH325A)
hydroxyproline (UNII: RMB44WO89X)
betaine (UNII: 3SCV180C9W)
steareth-21 (UNII: 53J3F32P58)
ethylhexyl palmitate (UNII: 2865993309)
glyceryl monostearate (UNII: 230OU9XXE4)
cholesterol (UNII: 97C5T2UQ7J)
alpha-tocopherol acetate (UNII: 9E8X80D2L0)
sucrose (UNII: C151H8M554)
high density polyethylene (UNII: UG00KM4WR7)
isohexadecane (UNII: 918X1OUF1E)
trehalose (UNII: B8WCK70T7I)
dipalmitoyl hydroxyproline (UNII: E6AHA53N1H)
Pimagedine Hydrochloride (UNII: A2Z7G2RGAH)
polysorbate 80 (UNII: 6OZP39ZG8H)
tromethamine (UNII: 023C2WHX2V)
caprylyl glycol (UNII: 00YIU5438U)
magnesium ascorbyl phosphate (UNII: 0R822556M5)
hyaluronate sodium (UNII: YSE9PPT4TH)
proline (UNII: 9DLQ4CIU6V)
ethylhexyl stearate (UNII: EG3PA2K3K5)
glycine (UNII: TE7660XO1C)
propylene glycol dicaprate (UNII: U783H9JHWY)
hexylene glycol (UNII: KEH0A3F75J)
potassium sulfate (UNII: 1K573LC5TV)
xanthan gum (UNII: TTV12P4NEE)
edetate disodium (UNII: 7FLD91C86K)
polyaminopropyl biguanide (UNII: 322U039GMF)
phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-732-01	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	03/01/2008

Labeler - CLINIQUE LABORATORIES INC. (173047747)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC Kabushiki Kaisha		712808195	RELABEL, REPACK

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

Establishment
Name	Address	ID/FEI	Business Operations
ARAMIS, INC		042918826	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK, RELABEL

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE

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

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		787336577	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		949264774	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		618107429	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE