CLINIQUE SPF 30 with SOLAR SMART

Dosage form: cream
Ingredients: octisalate 5mL in 100mL, homosalate 5mL in 100mL, oxybenzone 4mL in 100mL, avobenzone 3mL in 100mL, octocrylene 2.7mL in 100mL
Labeler: CLINIQUE LABORATORIES INC.
NDC Code: 49527-716

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

CLINIQUE
SPF
30
with
SolarSmart

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

OCTISALATE 5.0% • HOMOSALATE 5.0% • OXYBENZONE 4.0% • 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 • DIMETHICONE • GLYCERYL STEARATE • LAURDIMONIUM HYDROXYPROPYL HYDROLYZED SOY PROTEIN • ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT • PERILLA OCYMOIDES LEAF EXTRACT • PLANKTON 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 • PHOSPHOLIPIDS • LECITHIN • C1-8 ALKYL TETRAHYDROXYCYCLOHEXANOATE • HYDROXYETHYLCELLULOSE • TOCOPHERYL ACETATE • CAPRYLYL GLYCOL • ASCORBYL TOCOPHERYL MALEATE • STEARIC ACID • XANTHAN GUM • MALTODEXTRIN • FERULIC ACID • HEXYLENE GLYCOL • NORDIHYDROGUAIARETIC ACID • DISODIUM EDTA • PHENOXYETHANOL • MICA • SODIUM DEHYDROACETATE [ILN35074]

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

PRINCIPAL DISPLAY PANEL - 50 ml Carton

CLINIQUE

SPF
30
with
SolarSmart

UVA UVB
advanced
protection

face cream

1.7 FL. OZ.
50 ml e

CLINIQUE   SPF 30 WITH SOLAR SMART
octisalate, homosalate, oxybenzone, avobenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-716
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
octisalate (octisalate) octisalate5 mL  in 100 mL
homosalate (homosalate) homosalate5 mL  in 100 mL
oxybenzone (oxybenzone) oxybenzone4 mL  in 100 mL
avobenzone (avobenzone) avobenzone3 mL  in 100 mL
octocrylene (octocrylene) octocrylene2.7 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage Description
1NDC:49527-716-011 BOTTLE (BOTTLE) in 1 CARTON
150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/2010
Labeler - CLINIQUE LABORATORIES INC. (173047747)
Establishment
NameAddressID/FEIOperations
ELGC Kabushiki Kaisha712808195RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
ARAMIS, INC042918826MANUFACTURE
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK, RELABEL
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326MANUFACTURE
Establishment
NameAddressID/FEIOperations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE
Establishment
NameAddressID/FEIOperations
NORTEC KEYSTONE787336577MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
NORTHTEC BRISTOL949264774MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
NORTHTEC KEYSTONE618107429MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058MANUFACTURE

Revised: 10/2011
 
CLINIQUE LABORATORIES INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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