CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM with SOLAR SMART

Dosage form: cream
Ingredients: OCTISALATE 5.0mL in 100mL, HOMOSALATE 5.0mL in 100mL, OXYBENZONE 4.0mL in 100mL, AVOBENZONE 3.0mL in 100mL, OCTOCRYLENE 2.7mL in 100mL
Labeler: CLINIQUE LABS INC
NDC Code: 49527-736

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.

active ingredients: octisalate 5.00% [] homosalate 5.00% [] oxybenzone 4.00% [] avobenzone 3.00% [] octocrylene 2.70%

inactive 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 [] 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 [] arginine ferulate [] tocopheryl acetate [] caprylyl glycol [] ascorbyl tocopheryl maleate [] propyl gallate [] stearic acid [] xanthan gum [] hexylene glycol [] nordihydroguaiaretic acid [] disodium edta [] phenoxyethanol [] sodium dehydroacetate [] mica

 to use: apply liberally before sun exposure as needed. Reapply frequently, and after towel drying, swimming or perspiring

children under 6 months of age: ask a doctor

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.

PRINCIPAL DISPLAY PANEL:


CLINIQUE

spf 30

WITH SOLAR SMART

UVA/UVB

ADVANCED PROTECTION

BODY CREAM



5 FL OZ/150 ML


clinique labs inc.

new york, ny 10022





CLINIQUE  SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART
octisalate, homosalate, oxybenzone, avobenzone, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-736
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (OCTISALATE) OCTISALATE5.0 mL  in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE5.0 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE4.0 mL  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE3.0 mL  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE2.7 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
METHYL TRIMETHICONE 
BUTYLENE GLYCOL 
SHEA BUTTER 
SILICON DIOXIDE 
DIMETHICONE 
GLYCERYL MONOSTEARATE 
SUCROSE 
LECITHIN, SOYBEAN 
PHENOXYETHANOL 
XANTHAN GUM 
MICA 
Packaging
#Item CodePackage Description
1NDC:49527-736-011 TUBE (TUBE) in 1 CARTON
1NDC:49527-736-02150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2010
Labeler - CLINIQUE LABS INC (173047747)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIOperations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIOperations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIOperations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIOperations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIOperations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058manufacture

Revised: 02/2011
 
CLINIQUE LABS 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.

Hide
(web2)