IOPE RETIGEN SMOOTHING PACT NO.1 SPF25 PA PLUS PLUS- octinoxate, titanium dioxide and zinc oxide powder
IOPE RETIGEN SMOOTHING PACT NO.2 SPF25 PA PLUS PLUS- octinoxate, titanium dioxide and zinc oxide powder
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 RETIGEN SMOOTHING POWDER PACT

Drug Fact

Active ingredients

ETHYLHEXYL METHOXYCINNAMATE	6%
TITANIUM DIOXIDE	6.208%
ZINC OXIDE	2.94%

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 and irritation develops and lasts.

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

Directions

At the final step, lightly pat on the face, and carefully press on grooves around the nose and eyes.

Inactive ingredients

TALC, POLYMETHYL METHACRYLATE, SILICA, NYLON-12, BORON NITRIDE, PHENYL TRIMETHICONE, CAMELLIA SINENSIS LEAF EXTRACT, BETA-CAROTENE, CAPRYLYL GLYCOL, GLYCERIN, PROPANEDIOL, BETA-GLUCAN, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, HYDROLYZED EXTENSIN, ACRYLATES/AMMONIUM METHACRYLATE COPOLYMER, BUTYLENE GLYCOL, POLYACRYLIC ACID, TRIETHOXYCAPRYLYLSILANE, DIISOSTEARYL MALATE, METHICONE, LAUROYL LYSINE, ETHYLHEXYLGLYCERIN, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ACRYLATES/TRIDECYL ACRYLATE/TRIETHOXYSILYLPROPYL METHACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, GLYCERYL CAPRYLATE, WATER, DIMETHICONE, FRAGRANCE, MICA, TITANIUM DIOXIDE, ULTRAMARINES (CI 77007), IRON OXIDE (CI 77491), IRON OXIDE (CI 77492), IRON OXIDE (CI 77499)

AMOREPACIFIC US INC.
270 Sylvan Ave. #255 Englewood Cliffs, NJ07632

PRINCIPAL DISPLAY PANEL - 14 g Carton - NO. 1

IOPE

IOPE
RETIGEN
SMOOTHING POWDER PACT

PRINCIPAL DISPLAY PANEL - 14 g Carton - NO. 1

PRINCIPAL DISPLAY PANEL - 14 g Carton - NO. 2

IOPE

IOPE
RETIGEN
SMOOTHING POWDER PACT

PRINCIPAL DISPLAY PANEL - 14 g Carton - NO. 2

IOPE RETIGEN SMOOTHING PACT NO.1 SPF25 PA PLUS PLUS
octinoxate, titanium dioxide, and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:43419-314
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (OCTINOXATE)	OCTINOXATE	0.84 g in 14 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	0.86912 g in 14 g
ZINC OXIDE (ZINC OXIDE)	ZINC OXIDE	0.4116 g in 14 g

Ingredient Name	Strength
Inactive Ingredients
TALC
MICA
SILICON DIOXIDE
BORON NITRIDE
PHENYL TRIMETHICONE
TRIETHOXYCAPRYLYLSILANE
FERRIC OXIDE YELLOW
LAUROYL LYSINE
ETHYLHEXYLGLYCERIN
FERRIC OXIDE RED
GLYCERYL CAPRYLATE
WATER
DIMETHICONE
FERROSOFERRIC OXIDE
ULTRAMARINE BLUE
BUTYLENE GLYCOL
GREEN TEA LEAF
BETA CAROTENE
CAPRYLYL GLYCOL
GLYCERIN
PROPANEDIOL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43419-314-06	14 g in 1 CONTAINER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2011

IOPE RETIGEN SMOOTHING PACT NO.2 SPF25 PA PLUS PLUS
octinoxate, titanium dioxide, and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:43419-315
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (OCTINOXATE)	OCTINOXATE	0.84 g in 14 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	0.86912 g in 14 g
ZINC OXIDE (ZINC OXIDE)	ZINC OXIDE	0.4116 g in 14 g

Ingredient Name	Strength
Inactive Ingredients
TALC
MICA
SILICON DIOXIDE
BORON NITRIDE
PHENYL TRIMETHICONE
TRIETHOXYCAPRYLYLSILANE
FERRIC OXIDE YELLOW
LAUROYL LYSINE
ETHYLHEXYLGLYCERIN
FERRIC OXIDE RED
GLYCERYL CAPRYLATE
WATER
DIMETHICONE
FERROSOFERRIC OXIDE
ULTRAMARINE BLUE
BUTYLENE GLYCOL
GREEN TEA LEAF
BETA CAROTENE
CAPRYLYL GLYCOL
GLYCERIN
PROPANEDIOL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43419-315-06	14 g in 1 CONTAINER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2011

Labeler - AMOREPACIFIC (687995683)

Name	Address	ID/FEI	Business Operations
Establishment
AMOREPACIFIC		687995683	MANUFACTURE

Revised: 8/2011

Document Id: 4c1128ec-7f86-4586-bad2-af62014735ed

Set id: 35b952eb-07c4-4f65-967d-3d72b0fab878

Version: 1

Effective Time: 20110804

AMOREPACIFIC