IOPE BRIGHTGEN- oxybenzone, octinoxate, octisalate, homosalate, octocrylene and titanium dioxide lotion 
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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Iope Brightgen Sun Cream

Drug Facts

ACTIVE INGREDIENTS

BENZOPHENONE-34.5%
ETHYLHEXYL METHOXYCINNAMATE7%
ETHYLHEXYL SALICYLATE4.5%
HOMOSALATE5%
OCTOCRYLENE5%
TITANIUM DIOXIDE5.2%

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 and lasts

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply smoothly before sun exposure and as needed.

Children under 6 months of age : ask a doctor

INACTIVE INGREDIENTS

WATER, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, PHENYL TRIMETHICONE, GLYCERYL STEARATE, METHOXY PEG-114/POLYEPSILON CAPROLACTONE, PEG-100 STEARATE, PEG-40 STEARATE, CETEARYL ALCOHOL, ALUMINUM STEARATE, POLYACRYLATE-13, ALUMINA, POLYHYDROXYSTEARIC ACID, PHENOXYETHANOL, STEARIC ACID, POLYISOBUTENE, XANTHAN GUM, PORTULACA OLERACEA EXTRACT, MANNITO, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, POLYSORBATE 20, AMMONIUM GLYCYRRHIZATE, NIACINAMIDE, ZINC GLUCONATE, CAFFEINE, AESCULUS HIPPOCASTANUM (HORSE CHESTNUT) SEED EXTRACT, FOENICULUM VULGARE (FENNEL) SEED EXTRACT, FRAGRANCE

MANUFACTURER : COSMAX INC.
27 JEYAKGONGDAN 1, 46 JEYAKGONGDAN 2,
HYANGNAM, HWASEONG, GYEONGGI,
KOREA

DISTRIBUTOR : AMOREPACIFIC US INC.
DIST NEW YORK, NY 10018

PRINCIPAL DISPLAY PANEL - 60 ml Tube Carton

IOPE

BRIGHTGEN
SUN CREAM

SPF 50 +

CONTAINS SKINCHROMA
COMPLEX™

60 ml / 2.02 fl.oz.

PRINCIPAL DISPLAY PANEL - 60 ml Tube Carton
IOPE BRIGHTGEN 
oxybenzone, octinoxate, octisalate, homosalate, octocrylene, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:43419-330
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (OXYBENZONE) OXYBENZONE2.862 g  in 60 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE4.452 g  in 60 mL
OCTISALATE (OCTISALATE) OCTISALATE2.862 g  in 60 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE3.18 g  in 60 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE3.18 g  in 60 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE3.3072 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLENE GLYCOL 
ALKYL (C12-15) BENZOATE 
PHENYL TRIMETHICONE 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
PEG-40 STEARATE 
CETOSTEARYL ALCOHOL 
ALUMINUM STEARATE 
ALUMINUM OXIDE 
POLYHYDROXYSTEARIC ACID (2300 MW) 
PHENOXYETHANOL 
STEARIC ACID 
XANTHAN GUM 
PURSLANE 
MANNITOL 
ETHYLHEXYLGLYCERIN 
EDETATE DISODIUM 
POLYSORBATE 20 
AMMONIUM GLYCYRRHIZATE 
NIACINAMIDE 
ZINC GLUCONATE 
CAFFEINE 
HORSE CHESTNUT 
FENNEL SEED 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-330-181 in 1 CARTON
160 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/24/2012
Labeler - AMOREPACIFIC (687995683)
Establishment
NameAddressID/FEIBusiness Operations
AMOREPACIFIC687995683MANUFACTURE(43419-330)

Revised: 12/2012
 
AMOREPACIFIC