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

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

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 7.0%
ETHYLHEXYL SALICYLATE 4.5% OCTOCRYLENE 8.0% TITANIUM DIOXIDE 4.4%

PURPOSE

Sunscreen

USE

Helps prevent sunburn

WARNINGS

For external use only.

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

Stop use and ask a doctor if rash or irritation develops or lasts.

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

DIRECTIONS

Use in the morning and reapply regularly throughout the day if desired.

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, TRICHOLOMA MATSUTAKE EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, CAMELLIA SINENSIS LEAF POWDER, METHOXY PEG-114/POLYEPSILON CAPROLACTONE, PEG-100 STEARATE, GLYCERYL STEARATE, ALUMINUM STEARATE, POLYACRYLATE-13, POLYHYDROXYSTEARIC ACID, ALUMINA, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, POLYISOBUTENE, STEARIC ACID, CARBOMER, POLYSORBATE 20, EPIGALLOCATECHIN GALLATE, POLYGLUTAMIC ACID, THEANINE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, PARFUM/FRAGRANCE, IRON OXIDES (CI 77492, CI 77491)

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

FUTURE RESPONSE
Age Defense Creme SPF30

1.7 FL. OZ./ 50 ml e

AMOREPACIFIC

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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE3.6505 g  in 50 mL
OCTISALATE (OCTISALATE) OCTISALATE2.34675 g  in 50 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE4.172 g  in 50 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE2.2946 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLENE GLYCOL 
ALKYL (C12-15) BENZOATE 
CYCLOMETHICONE 5 
CETOSTEARYL ALCOHOL 
CYCLOMETHICONE 6 
1,2-HEXANEDIOL 
GREEN TEA LEAF 
PEG-100 STEARATE 
GLYCERYL MONOSTEARATE 
ALUMINUM STEARATE 
ALUMINUM OXIDE 
STEARIC ACID 
POLYSORBATE 20 
EPIGALLOCATECHIN GALLATE 
THEANINE 
CAPRYLYL GLYCOL 
ETHYLHEXYLGLYCERIN 
EDETATE DISODIUM 
FERRIC OXIDE YELLOW 
FERRIC OXIDE RED 
Packaging
#Item CodePackage Description
1NDC:43419-515-221 in 1 CARTON
150 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/25/2013
Labeler - AMOREPACIFIC (687995683)
Establishment
NameAddressID/FEIBusiness Operations
AMOREPACIFIC687995683MANUFACTURE(43419-515)

Revised: 01/2013
Document Id: 1b841af0-4080-4a13-8d5f-c31a6f34a32c
Set id: 2ba70ab3-a7ce-4096-ace4-09b78a83c792
Version: 1
Effective Time: 20130128
 
AMOREPACIFIC