CLINIQUE REDNESS SOLUTIONS  DAILY PROTECTIVE BASE SPF 15- titanium dioxide and zinc oxide cream 
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
redness solutions

WARNING

Keep out of eyes.

Stop use if irritation occurs.

Keep out of reach of children

ACTIVE INGREDIENTS

TITANIUM DIOXIDE 6.40% • ZINC OXIDE 2.00%

INGREDIENTS

WATER • TRIOCTYLDODECYL CITRATE • CYCLOPENTASILOXANE • BUTYLENE GLYCOL • C12-15 ALKYL BENZOATE • STEARETH-2 • STEARYL DIMETHICONE • TRICAPRYLYL CITRATE • SILICA • BARIUM SULFATE • SORBITAN TRISTEARATE • ALUMINUM STEARATE • ASCOPHYLLUM NODOSUM EXTRACT • ASPARAGOPSIS ARMATA EXTRACT • LECITHIN • SEA WHIP EXTRACT • GLYCERYL STEARATE • TOCOPHERYL ACETATE • PEG-100 STEARATE • SUCROSE • PANTETHINE • CAFFEINE • OCTYLDODECYL NEOPENTANOATE • CETETH-2 • PEG-40 STEARATE • DIMETHICONE • CETEARYL ALCOHOL • PEG/PPG-18/18 DIMETHICONE • STEARETH-20 • BISABOLOL • MAGNESIUM ASCORBYL PHOSPHATE • POLYGLYCERYL-6 POLYRICINOLEATE • SORBITOL • PHYTOSPHINGOSINE • SODIUM STEARATE • MAGNESIUM ALUMINUM SILICATE • CAPRYLYL GLYCOL • ISOPROPYL TITANIUM TRIISOSTEARATE • STEARIC ACID • HEXYLENE GLYCOL • XANTHAN GUM • DISODIUM EDTA • PHENOXYETHANOL • IRON OXIDES (CI 77491, CI 77492, CI 77499) • CHROMIUM HYDROXIDE GREEN (CI 77289) [ILN36209]

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

PRINCIPAL DISPLAY PANEL - 40 ml Carton

CLINIQUE

redness
solutions

daily
protective base
SPF 15

ALL SKIN TYPES

1.35 FL.OZ.LIQ./40 ml e

Principal Display Panel - 40 ml Carton

CLINIQUE REDNESS SOLUTIONS   DAILY PROTECTIVE BASE SPF 15
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-722
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.4 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
butylene glycol (UNII: 3XUS85K0RA)  
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
steareth-2 (UNII: V56DFE46J5)  
tricaprylyl citrate (UNII: BXW1GAI4TA)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
barium sulfate (UNII: 25BB7EKE2E)  
sorbitan tristearate (UNII: 6LUM696811)  
aluminum stearate (UNII: U6XF9NP8HM)  
ascophyllum nodosum (UNII: 168S4EO8YJ)  
asparagopsis armata (UNII: 2936KN6I1G)  
pseudopterogorgia elisabethae (UNII: UDY3H1OUX5)  
glyceryl monostearate (UNII: 230OU9XXE4)  
alpha-tocopherol acetate (UNII: 9E8X80D2L0)  
peg-100 stearate (UNII: YD01N1999R)  
sucrose (UNII: C151H8M554)  
pantethine (UNII: 7K81IL792L)  
caffeine (UNII: 3G6A5W338E)  
octyldodecyl neopentanoate (UNII: X8725R883T)  
ceteth-2 (UNII: 7H8VAM7778)  
peg-40 stearate (UNII: ECU18C66Q7)  
dimethicone (UNII: 92RU3N3Y1O)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
steareth-20 (UNII: L0Q8IK9E08)  
levomenol (UNII: 24WE03BX2T)  
magnesium ascorbyl phosphate (UNII: 0R822556M5)  
sorbitol (UNII: 506T60A25R)  
sodium stearate (UNII: QU7E2XA9TG)  
magnesium aluminum silicate (UNII: 6M3P64V0NC)  
caprylyl glycol (UNII: 00YIU5438U)  
stearic acid (UNII: 4ELV7Z65AP)  
hexylene glycol (UNII: KEH0A3F75J)  
xanthan gum (UNII: TTV12P4NEE)  
edetate disodium (UNII: 7FLD91C86K)  
phenoxyethanol (UNII: HIE492ZZ3T)  
ferric oxide red (UNII: 1K09F3G675)  
ferric oxide yellow (UNII: EX438O2MRT)  
ferrosoferric oxide (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-722-011 in 1 CARTON
140 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/01/2007
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: f22e64e9-8b07-4af1-9bbc-1978bf835562
Set id: cf49d7f3-01d8-490c-b9a4-ff69aee1e183
Version: 1
Effective Time: 20111201
 
CLINIQUE LABORATORIES INC