Medication Guide App

CLINIQUE skin supplies for men

Dosage form: lotion
Ingredients: octinoxate 7.4mL in 100mL, octisalate 5mL in 100mL, avobenzone 3mL in 100mL, oxybenzone 2mL in 100mL
Labeler: CLINIQUE LABORATORIES INC.
NDC Code: 49527-886

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
skin supplies
for men

WARNING

Keep out of eyes.

Stop use if irritation occurs. If irritation persists, consult a health care practitioner.

ACTIVE INGREDIENTS

OCTINOXATE 7.40% • OCTISALATE 5.00% • AVOBENZONE 3.00% • OXYBENZONE 2.00%

INGREDIENTS

WATER • BUTYLENE GLYCOL • DIMETHICONE • NEOPENTYL GLYCOL DIHEPTANOATE • CETEARYL ALCOHOL • SILICA • PEG-100 STEARATE • LACTOBACILLUS FERMENT • HORDEUM VULGARE (BARLEY) EXTRACT • ALGAE EXTRACT • CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT • HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE • CHOLESTEROL • CETEARYL GLUCOSIDE • PROPYLENE GLYCOL DICAPRATE • CHAMOMILLA RECUTITA (MATRICARIA) • TRIDECYL TRIMELLITATE • HYDROGENATED LECITHIN • STEARYL ALCOHOL • ZEOLITE • TRIDECYL STEARATE • ISODODECANE • DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE • PVP • OLETH-10 • LAURETH-4 • LAURETH-23 • CAPRYLYL GLYCOL • HEXYLENE GLYCOL • POLYETHYLENE • TROMETHAMINE • CARBOMER • SODIUM CITRATE • DISODIUM EDTA • SODIUM BENZOATE • POTASSIUM SORBATE • CHLORPHENESIN • PHENOXYETHANOL • YELLOW 5 (CI 19140) • YELLOW 6 (CI 15985) • RED 33 (CI 17200) [ILN29625]

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

PRINCIPAL DISPLAY PANEL - 100 ml Bottle Carton

CLINIQUE
skin supplies
for men

M protect
SPF 21

daily hydration + protection

ALL SKIN TYPES

3.4 FL.OZ.LIQ./100 ml e

CLINIQUE   SKIN SUPPLIES FOR MEN
octinoxate, octisalate, avobenzone, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-886
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
octinoxate (octinoxate) octinoxate7.4 mL  in 100 mL
octisalate (octisalate) octisalate5 mL  in 100 mL
avobenzone (avobenzone) avobenzone3 mL  in 100 mL
oxybenzone (oxybenzone) oxybenzone2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water 
butylene glycol 
dimethicone 
neopentyl glycol diheptanoate 
cetostearyl alcohol 
silicon dioxide 
peg-100 stearate 
barley 
cucumber 
helianthus annuus seedcake 
cholesterol 
cetearyl glucoside 
propylene glycol dicaprate 
matricaria recutita 
tridecyl trimellitate 
stearyl alcohol 
tridecyl stearate 
isododecane 
dipentaerythrityl hexacaprylate/hexacaprate 
oleth-10 
laureth-4 
laureth-23 
caprylyl glycol 
hexylene glycol 
high density polyethylene 
tromethamine 
sodium citrate 
edetate disodium 
sodium benzoate 
potassium sorbate 
chlorphenesin 
phenoxyethanol 
fd&c yellow no. 5 
fd&c yellow no. 6 
d&c red no. 33 
Packaging
#Item CodePackage Description
1NDC:49527-886-011 BOTTLE (BOTTLE) in 1 CARTON
1100 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/2004
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: 12/2011
 
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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