CLINIQUE  SKIN SUPPLIES FOR MEN- octinoxate, octisalate, avobenzone, and oxybenzone lotion 
CLINIQUE LABORATORIES INC.

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.

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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

Principal Display Panel - 100 ml Bottle Carton
CLINIQUE   SKIN SUPPLIES FOR MEN
octinoxate, octisalate, avobenzone, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-886
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate7.4 mL  in 100 mL
octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W) octisalate5 mL  in 100 mL
avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX) avobenzone3 mL  in 100 mL
oxybenzone (UNII: 95OOS7VE0Y) (oxybenzone - UNII:95OOS7VE0Y) oxybenzone2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
butylene glycol (UNII: 3XUS85K0RA)  
dimethicone (UNII: 92RU3N3Y1O)  
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
peg-100 stearate (UNII: YD01N1999R)  
barley (UNII: 5PWM7YLI7R)  
cucumber (UNII: YY7C30VXJT)  
helianthus annuus seedcake (UNII: 482WYF7XLC)  
cholesterol (UNII: 97C5T2UQ7J)  
cetearyl glucoside (UNII: 09FUA47KNA)  
propylene glycol dicaprate (UNII: U783H9JHWY)  
matricaria recutita (UNII: G0R4UBI2ZZ)  
tridecyl trimellitate (UNII: FY36J270ES)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
tridecyl stearate (UNII: A8OE252M6L)  
isododecane (UNII: A8289P68Y2)  
dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
oleth-10 (UNII: JD797EF70J)  
laureth-4 (UNII: 6HQ855798J)  
laureth-23 (UNII: N72LMW566G)  
caprylyl glycol (UNII: 00YIU5438U)  
hexylene glycol (UNII: KEH0A3F75J)  
high density polyethylene (UNII: UG00KM4WR7)  
tromethamine (UNII: 023C2WHX2V)  
sodium citrate (UNII: 1Q73Q2JULR)  
edetate disodium (UNII: 7FLD91C86K)  
sodium benzoate (UNII: OJ245FE5EU)  
potassium sorbate (UNII: 1VPU26JZZ4)  
chlorphenesin (UNII: I670DAL4SZ)  
phenoxyethanol (UNII: HIE492ZZ3T)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
fd&c yellow no. 6 (UNII: H77VEI93A8)  
d&c red no. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-886-011 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/FEIBusiness Operations
ELGC Kabushiki Kaisha712808195RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
ARAMIS, INC042918826MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK, RELABEL
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE787336577MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL949264774MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE618107429MANUFACTURE, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE

Revised: 12/2011
Document Id: 35c7c68e-924c-487c-bdd9-be60717eb96a
Set id: d2510515-c8c1-4086-a4a7-f1caadfaa6b7
Version: 1
Effective Time: 20111201
 
CLINIQUE LABORATORIES INC.