AMOREPACIFIC FUTURE RESPONSE AGE DEFENSE SPF30- octinoxate, octisalate, octocrylene, and titanium dioxide cream 
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 Creme SPF30

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

INACTIVE INGREDIENTS

AQUA/WATER/EAU, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, CYCLOHEXASILOXANE, 1,2-HEXANEDIOL, METHOXY PEG-114/POLYEPSILON CAPROLACTONE, PEG-100 STEARATE, GLYCERYL STEARATE, POLYACRYLATE-13, ALUMINUM STEARATE, POLYHYDROXYSTEARIC ACID, ALUMINA, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, POLYISOBUTENE, STEARIC ACID, ETHYLHEXYLGLYCERIN, CARBOMER, DISODIUM EDTA, POLYSORBATE 20, CAMELLIA SINENSIS LEAF POWDER, TRICHOLOMA MATSUTAKE EXTRACT, EPIGALLOCATECHIN GALLATE, POLYGLUTAMIC ACID, CAMELLIA SINENSIS LEAF EXTRACT, THEANINE, CAPRYLYL GLYCOL, PARFUM/FRAGRANCE, IRON OXIDES (CI 77492, CI 77491)

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

FUTURE RESPONSE
Age Defense Creme SPF30
Sunscreen

AMOREPACIFIC

1.69 FL. OZ./ 50 ml e

Principal Display Panel - 50 ml Jar Carton
AMOREPACIFIC FUTURE RESPONSE AGE DEFENSE SPF30 
octinoxate, octisalate, octocrylene, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-515
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.6505 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.34675 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4.172 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.2946 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)  
THEANINE (UNII: 8021PR16QO)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-515-221 in 1 CARTON01/25/201308/31/2019
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 not finalpart35201/25/201308/31/2019
Labeler - AMOREPACIFIC CORPORATION (631035289)
Establishment
NameAddressID/FEIBusiness Operations
AMOREPACIFIC CORPORATION694894112manufacture(43419-515)

Revised: 9/2019
 
AMOREPACIFIC CORPORATION