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CLINIQUE

CLINIQUE LABORATORIES INC.

CLINIQUE SPF 50 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

OXYBENZONE 5.0% • OCTISALATE 5.0% • HOMOSALATE 5.0% • AVOBENZONE 3.0% • OCTOCRYLENE 2.7%

INGREDIENTS

WATER • METHYL TRIMETHICONE • BUTYLENE GLYCOL • BUTYLOCTYL SALICYLATE • NEOPENTYL GLYCOL DIHEPTANOATE • BUTYROSPERMUM PARKII (SHEA BUTTER) • PEG-100 STEARATE • SILICA • DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • DIMETHICOME • GLYCERYL STEARATE • LAURDIMONIUM HYDROXYPROPYL HYDROLYZED SOY PROTEIN • ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT • PERILLA OCYMOIDES LEAF EXTRACT • CAFFEINE • POTASSIUM CETYL PHOSPHATE • SUCROSE • STYRENE/ACRYLATES COPOLYMER • C30-38 OLEFIN/ISOPROPYL MALEATE/MA COPOLYMER • CETYL ALCOHOL • VP/EICOSENE COPOLYMER • ETHYLHEXYLGLYCERIN • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER • PEG-8 LAURATE • SODIUM RNA • LECITHIN • ARGINNE FERULATE • TOCOPHERYL ACETATE • CAPRYLYL GLYCOL • PROPYL GALLATE • ASCORBYL TOCOPHERYL MALEATE • STEARIC ACID • XANTHAN GUM • HEXYLENE GLYCOL • NORDIHYDROGUAIARETIC ACID • DISODIUM EDTA • PHENOXYETHANOL • MICA • SODIUM DEHYDROACETATE [ILN37121]

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

PRINCIPAL DISPLAY PANEL - 150 ml Carton

CLINIQUE

SPF
50
with
SolarSmart

UVA UVB
advanced
protection

body cream

5 FL. OZ.
150 ml e

CLINIQUE

CLINIQUE

oxybenzone, octisalate, homosalate, avobenzone, and octocrylene CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49527-734
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

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

Inactive Ingredients

Ingredient Name Strength
water
METHYL TRIMETHICONE
BUTYLENE GLYCOL
BUTYLOCTYL SALICYLATE
NEOPENTYL GLYCOL DIHEPTANOATE
SHEA BUTTER
PEG-100 STEARATE
SILICON DIOXIDE
DIMETHICONE
GLYCERYL MONOSTEARATE
ROSEMARY
PERILLA FRUTESCENS LEAF
CAFFEINE
potassium cetyl phosphate
SUCROSE
CETYL ALCOHOL
ETHYLHEXYLGLYCERIN
PEG-8 LAURATE
ALPHA-TOCOPHEROL ACETATE
CAPRYLYL GLYCOL
STEARIC ACID
XANTHAN GUM
maltodextrin
ferulic acid
Hexylene Glycol
MASOPROCOL
EDETATE DISODIUM
PHENOXYETHANOL
MICA
SODIUM DEHYDROACETATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 150 in 1 BOTTLE
2 NDC:49527-734-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2009-03-02


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