CLINIQUE SPF 15 WITH SOLAR SMART ADVANCED PROTECTION- homosalate, octisalate, avobenzone, and octocrylene cream

CLINIQUE by

Drug Labeling and Warnings

CLINIQUE by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES 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]

TO USE

Apply liberally before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply frequently, and after towel drying, swimming or perspiring.

WARNING

For external use only. Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help right away.

ACTIVE INGREDIENTS

HOMOSALATE 10.0% OCTISALATE 5.0% AVOBENZONE 3.0% OCTOCRYLENE 2.7%

INGREDIENTS

WATER BUTYLENE GLYCOL ISONONYL ISONONANDATE BUTYLOCTYL SALICYLATE TRIACONTANYL PVP POLYESTER-8 SILICA ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT PERILLA OCYMOIDES LEAF EXTRACT STEARYL DIMETHICONE CAFFEINE PLANKTON EXTRACT SUCROSE HYDROGENATED LECITHIN POTASSIUM CETYL PHOSPHATE LAURDIMONIUM HYDROXYPROPYL HYDROLYZED SOY PROTEIN PEG-100 STEARATE CETYL ALCOHOL POLYETHYLENE ACRYLIC ACID/VP CROSSPOLYMER VP/EICOSENE COPOLYMER TOCOPHERYL ACETATE TROMETHAMINE SODIUM RNA ALOE BARBADENSIS POWDER PHOSPHOLIPIDS LECITHIN MAGNESIUM ASCORBYL PHOSPHATE SODIUM HYALURONATE HYDROXYPROPYL METHYLCELLULOSE C1-8 ALKYL TETRAHYDROXYCYCLOHEXANOATE HYDROXYETHYLCELLULOSE ASCORBYL TOCOPHERYL MALEATE MALTODEXTRIN CAPRYLYL GLYCOL HEXYLENE GLYCOL NORDIHYDROGUAIARETIC ACID FERULIC ACID DISODIUM EDTA PHENOXYETHANOL CHLORPHENESIN MICA [ILN34995]

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 150 ml Carton

CLINIQUE

SPF
15
with SolarSmart

UVA UVB
advanced
protection

face/body
cream

5 FL. OZ.
150 ml e

INGREDIENTS AND APPEARANCE

CLINIQUE   SPF 15 WITH SOLAR SMART ADVANCED PROTECTION
homosalate, octisalate, avobenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-735
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
homosalate (UNII: V06SV4M95S) (homosalate - UNII:V06SV4M95S)	homosalate	10 mL  in 100 mL
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

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
butylene glycol (UNII: 3XUS85K0RA)
isononyl isononanoate (UNII: S4V5BS6GCX)
butyloctyl salicylate (UNII: 2EH13UN8D3)
triacontanyl pvp (wp-660) (UNII: N0SS3Q238D)
silicon dioxide (UNII: ETJ7Z6XBU4)
rosemary (UNII: IJ67X351P9)
perilla frutescens leaf (UNII: T4L5881Y68)
caffeine (UNII: 3G6A5W338E)
sucrose (UNII: C151H8M554)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
peg-100 stearate (UNII: YD01N1999R)
cetyl alcohol (UNII: 936JST6JCN)
high density polyethylene (UNII: UG00KM4WR7)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
tromethamine (UNII: 023C2WHX2V)
magnesium ascorbyl phosphate (UNII: 0R822556M5)
hyaluronate sodium (UNII: YSE9PPT4TH)
maltodextrin (UNII: 7CVR7L4A2D)
caprylyl glycol (UNII: 00YIU5438U)
hexylene glycol (UNII: KEH0A3F75J)
masoprocol (UNII: 7BO8G1BYQU)
ferulic acid (UNII: AVM951ZWST)
edetate disodium (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)
chlorphenesin (UNII: I670DAL4SZ)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-735-01	1 in 1 CARTON
1		150 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	03/01/2009

Labeler - CLINIQUE LABORATORIES INC. (173047747)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(49527-735) , REPACK(49527-735)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(49527-735) , RELABEL(49527-735) , REPACK(49527-735)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc.		042918826	MANUFACTURE(49527-735)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(49527-735) , RELABEL(49527-735)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(49527-735)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-735)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(49527-735)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-735)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-735)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(49527-735) , RELABEL(49527-735) , REPACK(49527-735)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(49527-735) , RELABEL(49527-735) , REPACK(49527-735)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(49527-735) , RELABEL(49527-735) , REPACK(49527-735)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-735)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(49527-735)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(49527-735) , RELABEL(49527-735)