IOPE RETIGEN MOISTURE FOUNDATION NO.17 SPF22 PA PLUS

Dosage form: lotion
Ingredients: OCTINOXATE 1.75g in 35mL, TITANIUM DIOXIDE 0.8715g in 35mL, ZINC OXIDE 0.343g in 35mL
Labeler: AMOREPACIFIC
NDC Code: 43419-307

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 Moisture Foundation

Drug Facts

ACTIVE INGREDIENTS
ETHYLHEXYL METHOXYCINNAMATE5%
TITANIUM DIOXIDE2.49%
ZINC OXIDE0.98%

PURPOSE

Sunscreen

USES

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

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. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. 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

WATER, CYCLOPENTASILOXANE, TITANIUM DIOXIDE (CI 77891), CYCLOHEXASILOXANE, BUTYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, METHYL TRIMETHICONE, DIMETHICONE, SODIUM CHLORIDE, IRON OXIDES (CI 77492), OZOKERITE, PHENYL TRIMETHICONE, SORBITAN ISOSTEARATE, DISTEARDIMONIUM HECTORITE, DICAPRYLYL CARBONATE, POLYMETHYL METHACRYLATE, SQUALANE, POLYSILICONE-11, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, ALUMINUM HYDROXIDE, ETHYLHEXYLGLYCERIN, BEESWAX, COPERNICIA CERIFERA (CARNAUBA) WAX, HYDROGENATED CASTOR OIL ISOSTEARATE, RICINUS COMMUNIS (CASTOR) SEED OIL, STEARIC ACID, IRON OXIDES (CI 77491), TRIETHOXYCAPRYLYLSILANE, CAPRYLYL GLYCOL, FRAGRANCE, CALCIUM STEARATE, SORBITAN SESQUIOLEATE, ACRYLATES/AMMONIUM METHACRYLATE COPOLYMER, IRON OXIDES (CI 77499), DISODIUM EDTA, POLYACRYLIC ACID, CAMELLIA SINENSIS LEAF EXTRACT, HYDROLYZED EXTENSIN, BETA-CAROTENE, GLYCERIN, PROPANEDIOL, BETA-GLUCAN

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Carton - No. 17

IOPE

IOPE

RETIGEN
MOISTURE FOUNDATION

SUNSCREEN
BROAD SPECTRUM
[SPF 22]

35 ml/1.1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Carton - No. 21

IOPE

IOPE

RETIGEN
MOISTURE FOUNDATION

SUNSCREEN
BROAD SPECTRUM
[SPF 22]

35 ml/1.1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Carton - No. 23

IOPE

IOPE

RETIGEN
MOISTURE FOUNDATION

SUNSCREEN
BROAD SPECTRUM
[SPF 22]

35 ml/1.1 FL.OZ.

IOPE RETIGEN MOISTURE FOUNDATION   NO.17 SPF22 PA PLUS
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-307
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE1.75 g  in 35 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.8715 g  in 35 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.343 g  in 35 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
BUTYLENE GLYCOL 
METHYL TRIMETHICONE 
DIMETHICONE 
SODIUM CHLORIDE 
FERRIC OXIDE YELLOW 
DICAPRYLYL CARBONATE 
PHENYL TRIMETHICONE 
SQUALANE 
ALUMINUM HYDROXIDE 
ETHYLHEXYLGLYCERIN 
CASTOR OIL 
YELLOW WAX 
CARNAUBA WAX 
STEARIC ACID 
FERRIC OXIDE RED 
TRIETHOXYCAPRYLYLSILANE 
CAPRYLYL GLYCOL 
CALCIUM STEARATE 
SORBITAN SESQUIOLEATE 
FERROSOFERRIC OXIDE 
EDETATE DISODIUM 
GREEN TEA LEAF 
.BETA.-CAROTENE 
GLYCERIN 
PROPANEDIOL 
Packaging
#Item CodePackage Description
1NDC:43419-307-031 BOTTLE, PUMP in 1 CARTON
135 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/01/2011
IOPE RETIGEN MOISTURE FOUNDATION   NO.21 SPF22 PA PLUS
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-308
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE1.75 g  in 35 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.8715 g  in 35 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.343 g  in 35 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
BUTYLENE GLYCOL 
METHYL TRIMETHICONE 
DIMETHICONE 
SODIUM CHLORIDE 
FERRIC OXIDE YELLOW 
DICAPRYLYL CARBONATE 
PHENYL TRIMETHICONE 
SQUALANE 
ALUMINUM HYDROXIDE 
ETHYLHEXYLGLYCERIN 
CASTOR OIL 
YELLOW WAX 
CARNAUBA WAX 
STEARIC ACID 
FERRIC OXIDE RED 
TRIETHOXYCAPRYLYLSILANE 
CAPRYLYL GLYCOL 
CALCIUM STEARATE 
SORBITAN SESQUIOLEATE 
FERROSOFERRIC OXIDE 
EDETATE DISODIUM 
GREEN TEA LEAF 
.BETA.-CAROTENE 
GLYCERIN 
PROPANEDIOL 
Packaging
#Item CodePackage Description
1NDC:43419-308-031 BOTTLE, PUMP in 1 CARTON
135 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/01/2011
IOPE RETIGEN MOISTURE FOUNDATION   NO.23 SPF22 PA PLUS
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-309
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE1.75 g  in 35 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.8715 g  in 35 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.343 g  in 35 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
BUTYLENE GLYCOL 
METHYL TRIMETHICONE 
DIMETHICONE 
SODIUM CHLORIDE 
FERRIC OXIDE YELLOW 
DICAPRYLYL CARBONATE 
PHENYL TRIMETHICONE 
SQUALANE 
ALUMINUM HYDROXIDE 
ETHYLHEXYLGLYCERIN 
CASTOR OIL 
YELLOW WAX 
CARNAUBA WAX 
STEARIC ACID 
FERRIC OXIDE RED 
TRIETHOXYCAPRYLYLSILANE 
CAPRYLYL GLYCOL 
CALCIUM STEARATE 
SORBITAN SESQUIOLEATE 
FERROSOFERRIC OXIDE 
EDETATE DISODIUM 
GREEN TEA LEAF 
.BETA.-CAROTENE 
GLYCERIN 
PROPANEDIOL 
Packaging
#Item CodePackage Description
1NDC:43419-309-031 BOTTLE, PUMP in 1 CARTON
135 mL in 1 BOTTLE, PUMP
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(43419-307, 43419-308, 43419-309)

Revised: 02/2014
 
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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