REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY- octinoxate, octisalate, and titanium dioxide cream 
CLINIQUE LABORATORIES LLC

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

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 • simmondsia chinensis (jojoba) butter • petrolatum • polyethylene • glycerin • octyldodecyl neopentanoate • di-c12-15 alkyl fumarate • dimethicone • hydrogenated lecithin • butylene glycol • hydrogenated polyisobutene • hexyldecyl stearate • glyceryl stearate • pentylene glycol • potato starch modified • sigesbeckia orientalis (st. paul's wort) extract • salvia sclarea (clary) extract • chlorella vulgaris extract • commiphora mukul resin extract • litchi chinensis seed extract • laminaria digitata extract • plankton extract • cladosiphon okamuranus extract • whey protein\lactis protein\protéine du petit-lait • astrocaryum murumuru seed butter • sorbitol • caffeine • cholesterol • lecithin • acetyl hexapeptide-8 • sodium hyaluronate • peg-100 stearate • pentaerythrityl tetraethylhexanoate • behenyl alcohol • tocopheryl acetate • caprylyl glycol • c12-16 alcohols • caprylic/capric triglyceride • ergothioneine • polysilicone-11 • methicone • dextrin • palmitic acid • ammonium acryloyldimethyltaurate/vp copolymer • tetrahexyldecyl ascorbate • hexylene glycol • citric acid • potassium sorbate • xanthan gum • alumina • sodium hydroxide • disodium edta • phenoxyethanol • red 4 (ci 14700) • yellow 5 (ci 19140) • titanium dioxide (ci 77891) • mica [iln39282]

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

C

CLINIQUE

repairwear uplifting

firming cream
broad spectrum SPF 15

VERY DRY TO DRY

POIDS NET WT. 1.7 OZ./50 ml e

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
REPAIRWEAR  UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY
octinoxate, octisalate, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE35 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE17 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HEXYLDECYL STEARATE (UNII: OJX2P28Y14)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
CLARY SAGE (UNII: U3HSK5JC0Q)  
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)  
SORBITOL (UNII: 506T60A25R)  
CAFFEINE (UNII: 3G6A5W338E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
DOCOSANOL (UNII: 9G1OE216XY)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
C12-16 ALCOHOLS (UNII: S4827SZE3L)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
ICODEXTRIN (UNII: 2NX48Z0A9G)  
PALMITIC ACID (UNII: 2V16EO95H1)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
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:49527-017-011 in 1 CARTON11/24/2020
150 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02005/02/2012
Labeler - CLINIQUE LABORATORIES LLC (044475127)
Registrant - Estee Lauder Companies Inc. (790802086)
Establishment
NameAddressID/FEIBusiness Operations
The Estee Lauder Inc802599436manufacture(49527-017) , pack(49527-017) , label(49527-017)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774pack(49527-017) , label(49527-017)

Revised: 7/2023
Document Id: 017ad17c-87b5-dc4e-e063-6294a90ac5e0
Set id: 07701e11-8a7e-44c5-b46e-5b48264eacad
Version: 8
Effective Time: 20230727
 
CLINIQUE LABORATORIES LLC