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

CLINIQUE REDNESS SOLUTIONS by

Drug Labeling and Warnings

CLINIQUE REDNESS SOLUTIONS by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES INC, ELGC Kabushiki Kaisha, Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ARAMIS, INC, ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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]

SPL UNCLASSIFIED SECTION

© 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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-722
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.4 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-722-01	1 in 1 CARTON
1		40 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2007

Labeler - CLINIQUE LABORATORIES INC (173047747)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC Kabushiki Kaisha		712808195	RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
ARAMIS, INC		042918826	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK, RELABEL

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		787336577	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		949264774	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		618107429	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE