CLINIQUE  REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY COMBO OILY- octinoxate, octisalate, and titanium dioxide 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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REPAIRWEAR UPLIFTING FIRMING CREAM BROAD SPECTRUM SPF 15 DRY COMBO OILY

Drug Facts

Active ingredients

Octinoxate 7.5%
Octisalate 3.5%
Titanium dioxide 1.7%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

Inactive ingredients

water\aqua\eau • neopentyl glycol diheptanoate • simmondsia chinensis (jojoba) butter • glycerin • petrolatum • octyldodecyl neopentanoate • di-c12-15 alkyl fumarate • dimethicone • hydrogenated lecithin • butylene glycol • hydrogenated polyisobutene • hexyldecyl stearate • sigesbeckia orientalis (st. paul's wort) extract • whey protein\lactis protein\protéine du petit-lait • salvia sclarea (clary) extract • chlorella vulgaris extract • commiphora mukul resin extract • litchi chinensis seed extract • laminaria digitata extract • cladosiphon okamuranus extract • plankton extract • astrocaryum murumuru seed butter • acetyl hexapeptide-8 • lecithin • polyethylene • pentylene glycol • potato starch modified • ergothioneine • glyceryl stearate • caffeine • sorbitol • behenyl alcohol • sodium hyaluronate • methicone • tocopheryl acetate • peg-100 stearate • pentaerythrityl tetraethylhexanoate • caprylyl glycol • c12-16 alcohols • cholesterol • caprylic/capric triglyceride • polysilicone-11 • dextrin • palmitic acid • tetrahexyldecyl ascorbate • hexylene glycol • citric acid • xanthan gum • alumina • ammonium acryloyldimethyltaurate/vp copolymer • sodium hydroxide • disodium edta • potassium sorbate • phenoxyethanol • red 4 (ci 14700) • yellow 5 (ci 19140) • titanium dioxide (ci 77891) • mica [iln39272]

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

CLINIQUE

repairwear uplifting

firming cream
broad spectrum SPF 15

DRY COMBINATION TO COMBINATION OILY

POIDS NET WT. 1.7 OZ./50 ml e

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
CLINIQUE   REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY COMBO OILY
octinoxate, octisalate, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.7 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)  
glycerin (UNII: PDC6A3C0OX)  
petrolatum (UNII: 4T6H12BN9U)  
octyldodecyl neopentanoate (UNII: X8725R883T)  
di-c12-15 alkyl fumarate (UNII: A1CB3Z898P)  
dimethicone (UNII: 92RU3N3Y1O)  
butylene glycol (UNII: 3XUS85K0RA)  
hexyldecyl stearate (UNII: OJX2P28Y14)  
chlorella vulgaris (UNII: RYQ4R60M02)  
guggul (UNII: 34969JX79R)  
litchi chinensis seed (UNII: 9294024N9Q)  
laminaria digitata (UNII: 15E7C67EE8)  
cladosiphon okamuranus (UNII: 2IJE0CH09J)  
astrocaryum murumuru seed butter (UNII: 12V64UPU6R)  
acetyl hexapeptide-8 (UNII: L4EL31FWIL)  
high density polyethylene (UNII: UG00KM4WR7)  
pentylene glycol (UNII: 50C1307PZG)  
ergothioneine (UNII: BDZ3DQM98W)  
glyceryl monostearate (UNII: 230OU9XXE4)  
caffeine (UNII: 3G6A5W338E)  
sorbitol (UNII: 506T60A25R)  
docosanol (UNII: 9G1OE216XY)  
hyaluronate sodium (UNII: YSE9PPT4TH)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
peg-100 stearate (UNII: YD01N1999R)  
pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897)  
caprylyl glycol (UNII: 00YIU5438U)  
c12-16 alcohols (UNII: S4827SZE3L)  
cholesterol (UNII: 97C5T2UQ7J)  
medium-chain triglycerides (UNII: C9H2L21V7U)  
icodextrin (UNII: 2NX48Z0A9G)  
palmitic acid (UNII: 2V16EO95H1)  
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
hexylene glycol (UNII: KEH0A3F75J)  
citric acid monohydrate (UNII: 2968PHW8QP)  
xanthan gum (UNII: TTV12P4NEE)  
aluminum oxide (UNII: LMI26O6933)  
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)  
sodium hydroxide (UNII: 55X04QC32I)  
edetate disodium (UNII: 7FLD91C86K)  
potassium sorbate (UNII: 1VPU26JZZ4)  
phenoxyethanol (UNII: HIE492ZZ3T)  
FD&C red no. 4 (UNII: X3W0AM1JLX)  
FD&C yellow no. 5 (UNII: I753WB2F1M)  
mica (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-014-011 in 1 CARTON
150 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/02/2012
Labeler - CLINIQUE LABORATORIES INC (173047747)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(49527-014) , REPACK(49527-014)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(49527-014) , RELABEL(49527-014) , REPACK(49527-014)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Inc.042918826MANUFACTURE(49527-014)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(49527-014) , RELABEL(49527-014)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(49527-014)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(49527-014)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(49527-014)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(49527-014)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(49527-014)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE943871157MANUFACTURE(49527-014) , RELABEL(49527-014) , REPACK(49527-014)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL959338336MANUFACTURE(49527-014) , RELABEL(49527-014) , REPACK(49527-014)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774MANUFACTURE(49527-014) , RELABEL(49527-014) , REPACK(49527-014)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(49527-014)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(49527-014)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center078364654REPACK(49527-014) , RELABEL(49527-014)

Revised: 8/2012
Document Id: 8efb261e-c071-4029-863e-b60335b75899
Set id: 50755a3c-219a-403c-a365-a35560f77ef3
Version: 1
Effective Time: 20120816
 
CLINIQUE LABORATORIES INC