IOPE RETIGEN GLOW COVER CAKE NO.21 SPF33 PA PLUS PLUS- octinoxate, titanium dioxide and zinc oxide cream
IOPE RETIGEN GLOW COVER CAKE NO.23 SPF33 PA PLUS PLUS- octinoxate, titanium dioxide and zinc oxide 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.

----------

IOPE
RETIGEN
GLOW COVER CAKE

Drug Fact

Active ingredients

ETHYLHEXYL METHOXYCINNAMATE	5%
TITANIUM DIOXIDE	2.49%
ZINC OXIDE	1.96%

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

After applying the base, apply on the face using the provided puff.

-: Light and natural skin expression : Lightly apply a little bit at a time using the puff.
-: Smooth and spot covered skin expression : Place an appropriate amount on the puff, and dab onto the face.

Inactive ingredients

WATER, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, CYCLOPENTASILOXANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROGENATED POLYDECENE, POLYMETHYL METHACRYLATE, CYCLOHEXASILOXANE, BUTYLENE GLYCOL, BARIUM SULFATE, OZOKERITE, CETYL PEG/PPG-10/1 DIMETHICONE, SORBITAN ISOSTEARATE, POLYETHYLENE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, GLYCERIN, CAMELLIA SINENSIS LEAF EXTRACT, HYDROLYZED EXTENSIN, BETA-CAROTENE, ADENOSINE, BETA-GLUCAN VP/HEXADECENE COPOLYMER, SORBITAN SESQUIOLEATE, CERESIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, STEARIC ACID, ACRYLATES/AMMONIUM METHACRYLATE COPOLYMER, POLYACRYLIC ACID, DISODIUM EDTA, TRIETHOXYCAPRYLYLSILANE, SILICA, MAGNESIUM MYRISTATE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, CAPRYLYL GLYCOL, PROPANEDIOL, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDE (CI 77492), IRON OXIDE (CI 77491), IRON OXIDE (CI 77499)

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

PRINCIPAL DISPLAY PANEL - 14 g Container (#21)

IOPE

IOPE
RETIGEN
GLOW COVER CAKE

Principal Display Panel - 14 g Container (#21)

PRINCIPAL DISPLAY PANEL - 14 g Container (#23)

IOPE

IOPE
RETIGEN
GLOW COVER CAKE

Principal Display Panel - 14 g Container (#23)

IOPE RETIGEN GLOW COVER CAKE NO.21 SPF33 PA PLUS PLUS
octinoxate, titanium dioxide, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:43419-302
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (OCTINOXATE)	OCTINOXATE	0.7 g in 14 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	0.3486 g in 14 g
ZINC OXIDE (ZINC OXIDE)	ZINC OXIDE	0.2744 g in 14 g

Ingredient Name	Strength
Inactive Ingredients
WATER
CYCLOMETHICONE 5
MEDIUM-CHAIN TRIGLYCERIDES
CYCLOMETHICONE 6
BUTYLENE GLYCOL
BARIUM SULFATE
FERRIC OXIDE YELLOW
GLYCERIN
SORBITAN SESQUIOLEATE
CERESIN
FERRIC OXIDE RED
SODIUM CHLORIDE
ALUMINUM HYDROXIDE
STEARIC ACID
FERROSOFERRIC OXIDE
EDETATE DISODIUM
ADENOSINE
TRIETHOXYCAPRYLYLSILANE
SILICON DIOXIDE
MAGNESIUM MYRISTATE
GREEN TEA LEAF
BETA CAROTENE
CAPRYLYL GLYCOL
PROPANEDIOL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43419-302-06	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 GLOW COVER CAKE NO.23 SPF33 PA PLUS PLUS
octinoxate, titanium dioxide, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:43419-303
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (OCTINOXATE)	OCTINOXATE	0.7 g in 14 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	0.3486 g in 14 g
ZINC OXIDE (ZINC OXIDE)	ZINC OXIDE	0.2744 g in 14 g

Ingredient Name	Strength
Inactive Ingredients
WATER
CYCLOMETHICONE 5
MEDIUM-CHAIN TRIGLYCERIDES
CYCLOMETHICONE 6
BUTYLENE GLYCOL
BARIUM SULFATE
FERRIC OXIDE YELLOW
GLYCERIN
SORBITAN SESQUIOLEATE
CERESIN
FERRIC OXIDE RED
SODIUM CHLORIDE
ALUMINUM HYDROXIDE
STEARIC ACID
FERROSOFERRIC OXIDE
EDETATE DISODIUM
ADENOSINE
TRIETHOXYCAPRYLYLSILANE
SILICON DIOXIDE
MAGNESIUM MYRISTATE
GREEN TEA LEAF
BETA CAROTENE
CAPRYLYL GLYCOL
PROPANEDIOL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43419-303-06	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: 6baf5ebd-6fef-49f9-b086-397206b2ed4f

Set id: 9806be5b-1476-4bc9-9ac4-34789a0a8192

Version: 1

Effective Time: 20110804

AMOREPACIFIC