Drug Facts

Drug Labeling and Warnings

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LOREAL PARIS SKIN EXPERTISE REVITALIFT DEEP-SET WRINKLE REPAIR EYE 24 HOUR EYE REPAIR DUO SPF 15- avobenzone, octisalate and octocrylene lotion 
L'Oreal USA Products 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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Drug Facts

AVOBENZONE 3%; OCTISALATE 5%; OCTOCRYLENE 3%

Directions

Apply prior to sun exposure. Use everyday for maximum results.

Warnings

FOR EXTERNAL USE ONLY

When using this product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

Stop use and ask a doctor

IF SIGNS OF IRRITATION OR RASH APPEAR. IF IRRITATION OR RASH PERSISTS, CONSULT A DOCTOR. 

Keep out of reach of children.

NOT TO BE SWALLOWED.

Inactive ingredients

WATER
C12-15 ALKYL BENZOATE
ISONONYL ISONONANOATE
ALCOHOL DENAT.
GLYCERIN
CYCLOHEXASILOXANE
PROPYLENE GLYCOL
ETHYLHEXYL PALMITATE
POLY C10-30 ALKYL ACRYLATE
BUTYLENE GLYCOL
ALUMINUM STARCH OCTENYLSUCCINATE
DIMETHICONE
NYLON-66
STYRENE/ACRYLATES COPOLYMER
GLYCERYL STEARATE
BEHENYL ALCOHOL
GLYCERYL STEARATE CITRATE
TRIETHANOLAMINE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER
DIMETHYL ISOSORBIDE
SODIUM CITRATE
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL
VIGNA ACONITIFOLIA SEED EXTRACT
ASCORBYL GLUCOSIDE
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE
CAPRYLOYL SALICYLIC ACID
ACETYL TRIFLUOROMETHYLPHENYL VALYLGLYCINE
CRITHMUM MARITIMUM EXTRACT
XANTHAN GUM
OCTYLDODECANOL
RETINYL PALMITATE
PHENOXYETHANOL
MICA
TITANIUM DIOXIDE

image of a label

LOREAL PARIS SKIN EXPERTISE REVITALIFT DEEP-SET WRINKLE REPAIR EYE 24 HOUR EYE REPAIR DUO SPF 15 
avobenzone, octisalate and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49967-686
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)  
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49967-686-011 in 1 CARTON06/01/200907/01/2015
16 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/200907/01/2015
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA Products Inc624244349manufacture(49967-686)

Revised: 12/2018