IOPE PERFECT SKIN TWIN PACT NO 21- titanium dioxide and zinc oxide powder 
IOPE PERFECT SKIN TWIN PACT NO 23- titanium dioxide and zinc oxide powder 
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.

----------

IOPE Perfect Skin Twin Pact

Drug Facts

ACTIVE INGREDIENTS

TITANIUM DIOXIDE 9.31%, ZINC OXIDE 2.94%

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

TALC, SYNTHETIC FLUORPHLOGOPITE, SILICA, TITANIUM DIOXIDE (CI 77891), MICA (CI 77019), OCTYLDODECYL STEAROYL STEARATE, ETHYLENE/ACRYLIC ACID COPOLYMER, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, IRON OXIDES (CI 77492), PEG-10 DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, METHICONE, DIMETHICONE, FRAGRANCE, IRON OXIDES (CI 77491), ETHYLHEXYLGLYCERIN, ALU-INUM HYDROXIDE, GLYCERYL CAPRYLATE, IRON OXIDES (CI 77499), TIN OXIDE, ETHYLHEXYL PALMITATE, SILICA DIMETHYL SILYLATE, BUTYLENE GLYCOL, SODIUM HYALURONATE

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - NO 21

IOPE

PERFECT SKIN
TWIN PACT

SUNSCREEN
[SPF 14]

HYALURONIC FORMULA

12 g / 0.4 OZ.

Principal Display Panel - 12 g Container Carton - no 21

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - NO 23

IOPE

PERFECT SKIN
TWIN PACT

SUNSCREEN
[SPF 14]

HYALURONIC FORMULA

12 g / 0.4 OZ.

Principal Display Panel - 12 g Container Carton - no 23
IOPE PERFECT SKIN TWIN PACT NO 21 
titanium dioxide and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-780
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.1172 g  in 12 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.3528 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
STANNOUS OXIDE (UNII: JB2MV9I3LS)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-780-171 in 1 CARTON01/20/201510/01/2018
112 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/20/201510/01/2018
IOPE PERFECT SKIN TWIN PACT NO 23 
titanium dioxide and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-781
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.1172 g  in 12 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.3528 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
STANNOUS OXIDE (UNII: JB2MV9I3LS)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-781-171 in 1 CARTON01/20/201510/01/2018
112 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/20/201510/01/2018
Labeler - Amorepacific Corporation (631035289)

Revised: 10/2018
Document Id: 67e9765d-8e02-4180-9097-3fe1089d6b1a
Set id: 4b048732-50a1-4e90-8798-8ffe239b7e23
Version: 4
Effective Time: 20181018
 
Amorepacific Corporation