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CLINIQUE

CLINIQUE LABORATORIES INC.

CLINIQUE SPF 15 with SolarSmart


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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]

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

CLINIQUE

CLINIQUE

homosalate, octisalate, avobenzone, and octocrylene CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49527-735
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HOMOSALATE Homosalate 10 mL
OCTISALATE OCTISALATE 5 mL
AVOBENZONE AVOBENZONE 3 mL
OCTOCRYLENE Octocrylene 2.7 mL

Inactive Ingredients

Ingredient Name Strength
water
BUTYLENE GLYCOL
ISONONYL ISONONANOATE
BUTYLOCTYL SALICYLATE
TRIACONTANYL PVP (WP-660)
SILICON DIOXIDE
ROSEMARY
PERILLA FRUTESCENS LEAF
CAFFEINE
SUCROSE
potassium cetyl phosphate
PEG-100 STEARATE
CETYL ALCOHOL
HIGH DENSITY POLYETHYLENE
.ALPHA.-TOCOPHEROL ACETATE
tromethamine
Magnesium Ascorbyl Phosphate
HYALURONATE SODIUM
maltodextrin
CAPRYLYL GLYCOL
Hexylene Glycol
MASOPROCOL
ferulic acid
EDETATE DISODIUM
PHENOXYETHANOL
CHLORPHENESIN
MICA

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2009-03-01


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