IOPE PERFECT SKIN BASE- octinoxate lotion 
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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IOPE Perfect Skin Base

Drug Facts

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 6.5 %

PURPOSE

Sunscreen

USES

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

WATER, DIMETHICONE, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, PHENYL TRIMETHICONE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, NEOPENTYL GLYCOL DIHEPTANOATE, DISTEARDIMONIUM HECTORITE, BORON NITRIDE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRISILOXANE, TITANIUM DIOXIDE (CI 77891), CYCLOHEXASILOXANE, METHYL METHACRYLATE CROSSPOLYMER, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SORBITAN ISOSTEARATE, SODIUM CHLORIDE, POLYMETHYL METHACRYLATE, POLYSILICONE-11, TRIMETHYLSILOXYSILICATE, PHENOXYETHANOL, CAPRYLYL GLYCOL, FRAGRANCE, CHROMIUM OXIDE GREENS (CI 77288), ETHYLHEXYLGLYCERIN, ALUMINUM HYDROXIDE, SYNTHETIC FLUORPHLOGOPITE, TRIETHOXYCAPRYLYLSILANE, DISODIUM EDTA, ADENOSINE, ETHYLHEXYL PALMITATE, TIN OXIDE, SILICA DIMETHYL SILYLATE, SODIUM HYALURONATE

OTHER INFORMATION

Protect the product in this container from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Carton

IOPE

PERFECT SKIN
BASE

SUNSCREEN
BROAD SPECTRUM
[SPF 11]

HYALURONIC FORMULA

LIGHT GREEN

35 ml / 1.1 FL.OZ.

Principal Display Panel - 35 ml Bottle Carton
IOPE PERFECT SKIN BASE 
octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-375
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2275 mg  in 35 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHROMIC OXIDE (UNII: X5Z09SU859)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ADENOSINE (UNII: K72T3FS567)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-375-031 in 1 CARTON01/15/201508/31/2019
135 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/15/201508/31/2019
Labeler - Amorepacific Corporation (631035289)
Establishment
NameAddressID/FEIBusiness Operations
Amorepacific Corporation694894112manufacture(43419-375)

Revised: 9/2019
 
Amorepacific Corporation