IOPE RETIGEN SMOOTHING PACT NO.1 SPF25 PA PLUS PLUS

Dosage form: powder
Ingredients: OCTINOXATE 0.84g in 14g, TITANIUM DIOXIDE 0.86912g in 14g, ZINC OXIDE 0.4116g in 14g
Labeler: AMOREPACIFIC
NDC Code: 43419-314

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 SMOOTHING POWDER PACT

Drug Fact

Active ingredients
ETHYLHEXYL METHOXYCINNAMATE6%
TITANIUM DIOXIDE6.208%
ZINC OXIDE2.94%

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. 2

IOPE

IOPE
RETIGEN
SMOOTHING POWDER PACT

IOPE RETIGEN SMOOTHING PACT  NO.1 SPF25 PA PLUS PLUS
octinoxate, titanium dioxide, and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-314
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE0.84 g  in 14 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.86912 g  in 14 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.4116 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:43419-314-0614 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/01/2011
IOPE RETIGEN SMOOTHING PACT  NO.2 SPF25 PA PLUS PLUS
octinoxate, titanium dioxide, and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-315
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE0.84 g  in 14 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.86912 g  in 14 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.4116 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:43419-315-0614 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/01/2011
Labeler - AMOREPACIFIC (687995683)
Establishment
NameAddressID/FEIOperations
AMOREPACIFIC687995683MANUFACTURE

Revised: 08/2011
 
AMOREPACIFIC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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