AMOREPACIFIC FUTURE RESPONSE AGE DEFENSE DUAL EYE CREME WITH SPF 25 SUNSCREEN

Drug Labeling and Warnings

Drug Details [pdf]

AMOREPACIFIC FUTURE RESPONSE AGE DEFENSE DUAL EYE WITH SPF 25 SUNSCREEN- octinoxate, octisalate, octocrylene, and titanium dioxide 
Amorepacific Corporation

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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AMOREPACIFIC FUTURE RESPONSE AGE DEFENSE DUAL EYE CREME WITH SPF 25 SUNSCREEN

DAY SPF 25

Drug Facts

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 7% ETHYLHEXYL SALICYLATE 4.5% OCTOCRYLENE 8% TITANIUM DIOXIDE 4.4%

PURPOSE

Sunscreen

USE

  • helps prevent sunburn

WARNINGS

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

  • 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

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor

OTHER INFORMATION

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

INACTIVE INGREDIENTS

CAMELLIA SINENSIS LEAF WATER, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, ALCOHOL, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, CYCLOHEXASILOXANE, METHOXY PEG-114/POLYEPSILON CAPROLACTONE, 1,2-HEXANEDIOL, GLYCERYL STEARATE, GLYCERYL CAPRYLATE, CAMELLIA SINENSIS LEAF EXTRACT, DISODIUM EDTA, PRUNUS MUME FRUIT EXTRACT, TRICHOLOMA MATSUTAKE EXTRACT, STEARIC ACID, ALUMINA, ALUMINUM STEARATE, ETHYLHEXYLGLYCERIN, AQUA/WATER/EAU, CARBOMER, KAOLIN, CAPRYLYL GLYCOL, PHENOXYETHANOL, POLYSORBATE 20, POLYACRYLATE-13, POLYISOBUTENE, POLYHYDROXYSTEARIC ACID, PEG-100 STEARATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, PARFUM/FRAGRANCE

NIGHT

Drug Facts

INACTIVE INGREDIENTS

CAMELLIA SINENSIS LEAF WATER, BUTYLENE GLYCOL, GLYCERIN, HYDROGENATED POLY(C6-14 OLEFIN), ALCOHOL, PENTAERYTHRITYL TETRAETHYLHEXANOATE, AQUA/WATER/EAU, TRIOCTYLDODECYL CITRATE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, GLYCERYL STEARATE, BEHENYL ALCOHOL, DIMETHICONE, PHYTOSTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE, DIPALMITOYL HYDROXYPROLINE, THEANINE, CAMELLIA SINENSIS LEAF EXTRACT, TRICHOLOMA MATSUTAKE EXTRACT, CAMELLIA SINENSIS LEAF POWDER, SODIUM HYALURONATE, CAFFEINE, POLYGLUTAMIC ACID, EPIGALLOCATECHIN GALLATE, KAOLIN, TRISILOXANE, PEG-100 STEARATE, CETEARYL ALCOHOL, HYDROXYETHYL ACRYLATE /SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, POLYACRYLATE-13, POLYISOBUTENE, ETHYLHEXYLGLYCERIN, POLYSORBATE 20, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, PHENOXYETHANOL, DISODIUM EDTA, PARFUM/FRAGRANCE

PRINCIPAL DISPLAY PANEL - Kit Carton

FUTURE RESPONSE
Age Defense Dual Eye Creme

Day SPF 25 sunscreen

0.33 FL. OZ./ 10 ml + 0.33 FL. OZ./ 10 ml e

AMOREPACIFIC

Night

Principal Display Panel - Kit Carton
AMOREPACIFIC FUTURE RESPONSE AGE DEFENSE DUAL EYE WITH SPF 25 SUNSCREEN 
octinoxate, octisalate, octocrylene, and titanium dioxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-516
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-516-261 in 1 CARTON; Type 0: Not a Combination Product11/05/201808/31/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 JAR 10 mL
Part 21 JAR 10 mL
Part 1 of 2
CREAM   DAY SPF 25
octinoxate, octisalate, octocrylene, and titanium dioxide cream
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.7 g  in 10 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.45 g  in 10 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.8 g  in 10 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.44 g  in 10 mL
Inactive Ingredients
Ingredient NameStrength
TEA LEAF OIL (UNII: VC855RRT77)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ALCOHOL (UNII: 3K9958V90M)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PRUNUS MUME FRUIT (UNII: 639190I8CU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
WATER (UNII: 059QF0KO0R)  
KAOLIN (UNII: 24H4NWX5CO)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PEG-100 STEARATE (UNII: YD01N1999R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
110 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/08/2014
Part 2 of 2
CREAM   NIGHT
eye lotion cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRTEA LEAF OIL (UNII: VC855RRT77)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRALCOHOL (UNII: 3K9958V90M)  
INGRPENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
INGRWATER (UNII: 059QF0KO0R)  
INGRTRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRDOCOSANOL (UNII: 9G1OE216XY)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRDIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
INGRTHEANINE (UNII: 8021PR16QO)  
INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRCAFFEINE (UNII: 3G6A5W338E)  
INGREPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)  
INGRKAOLIN (UNII: 24H4NWX5CO)  
INGRTRISILOXANE (UNII: 9G1ZW13R0G)  
INGRPEG-100 STEARATE (UNII: YD01N1999R)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
110 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/08/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/08/201408/31/2019
Labeler - Amorepacific Corporation (631035289)
Establishment
NameAddressID/FEIBusiness Operations
Amorepacific Corporation694894112manufacture(43419-516)

Revised: 9/2019
Document Id: 91d2c679-5e2c-86cf-e053-2a95a90ae3d9
Set id: 9b0262a6-13a6-40c7-81d1-3f448aeea70b
Version: 4
Effective Time: 20190905