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 Facts

ACTIVE INGREDIENTS 
ETHYLHEXYL METHOXYCINNAMATE6%
TITANIUM DIOXIDE6.208%
ZINC OXIDE2.94%

PURPOSE

Sunscreen

USE

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.

Other information

protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENTS

TALC, POLYMETHYL METHACRYLATE, SILICA, NYLON-12, BORON NITRIDE, PHENYL TRIMETHICONE, TRIETHOXYCAPRYLYLSILANE, DIISOSTEARYL MALATE,METHICONE, LAUROYL LYSINE, ETHYLHEXYLGLYCERIN, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER,ACRYLATES/TRIDECYL ACRYLATE/TRIETHOXYSILYLPROPYL METHACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, GLYCERYL CAPRYLATE, ALUMINUM HYDROXIDE, WATER, DIMETHICONE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, HYDROLYZED EXTENSIN, ACRYLATES/AMMONIUM METHACRYLATE COPOLYMER, BUTYLENE GLYCOL, POLYACRYLIC ACID, CAMELLIA SINENSIS LEAF EXTRACT, BETA-CAROTENE, CAPRYLYL GLYCOL, GLYCERIN, PROPANEDIOL, BETA-GLUCAN, FRAGRANCE, MICA (CI 77019), TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499), ULTRAMARINES (CI 77007)

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - No. 1

IOPE

IOPE

RETIGEN
SMOOTHING POWDER PACT

SUNSCREEN
[SPF 25]

Net wt. 14 g/0.4 OZ.

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - No. 2

IOPE

IOPE

RETIGEN
SMOOTHING POWDER PACT

SUNSCREEN
[SPF 25]

Net wt. 14 g/0.4 OZ.

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 
ALUMINUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:43419-314-061 CONTAINER in 1 CARTON
114 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 
ALUMINUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:43419-315-061 CONTAINER in 1 CARTON
114 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(43419-314, 43419-315)

Revised: 12/2013
 
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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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