IOPE RETIGEN MOISTURE BASE NATURAL YELLOW

Dosage form: lotion
Ingredients: OCTINOXATE 2.45g in 35mL, TITANIUM DIOXIDE 0.581g in 35mL, ZINC OXIDE 0.686g in 35mL
Labeler: AMOREPACIFIC
NDC Code: 43419-304

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 BASE

Drug Facts

ACTIVE INGREDIENTS
ETHYLHEXYL METHOXYCINNAMATE7%
TITANIUM DIOXIDE1.66%
ZINC OXIDE1.96%

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, CYCLOHEXASILOXANE, PHENYL TRIMETHICONE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, BUTYLENE GLYCOL, ARBUTIN, TRIETHYLHEXANOIN, NEOPENTYL GLYCOL DIHEPTANOATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, DIMETHICONE, POLYMETHYL METHACRYLATE, SQUALANE, CAMELLIA SINENSIS LEAF EXTRACT, HYDROLYZED EXTENSIN, SODIUM HYALURONATE, BETA-CAROTENE, BETA-GLUCAN, SODIUM CHLORIDE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SORBITAN ISOSTEARATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ALUMINUM HYDROXIDE, CALCIUM STEARATE, CAPRYLYL GLYCOL, STEARIC ACID, SORBITAN SESQUIOLEATE, GLYCERIN, TRIETHOXYCAPRYLYLSILANE, ACRYLATES/AMMONIUM METHACRYLATE COPOLYMER, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, SILICA, ADENOSINE, POLYACRYLIC ACID, PROPANEDIOL, PHENOXYETHANOL, ALCOHOL, FRAGRANCE, TITANIUM DIOXIDE (CI 77891), CHROMIUM OXIDE GREENS (CI 77288), ULTRAMARINES (CI 77007) , IRON OXIDES (CI 77492)

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Carton (natural yellow)

IOPE

IOPE
RETIGEN
MOISTURE BASE

SUNSCREEN
BROAD SPECTRUM
[SPF 34]

35 ml/1.1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Carton (natural green)

IOPE

IOPE
RETIGEN
MOISTURE BASE

SUNSCREEN
BROAD SPECTRUM
[SPF 34]

35 ml/1.1 FL.OZ.

IOPE RETIGEN MOISTURE BASE NATURAL YELLOW 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-304
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE2.45 g  in 35 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.581 g  in 35 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.686 g  in 35 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
PHENYL TRIMETHICONE 
BUTYLENE GLYCOL 
TRIETHYLHEXANOIN 
NEOPENTYL GLYCOL DIHEPTANOATE 
ARBUTIN 
DIMETHICONE 
SQUALANE 
SODIUM CHLORIDE 
PHENOXYETHANOL 
ALUMINUM HYDROXIDE 
CALCIUM STEARATE 
CAPRYLYL GLYCOL 
STEARIC ACID 
SORBITAN SESQUIOLEATE 
GLYCERIN 
TRIETHOXYCAPRYLYLSILANE 
FERRIC OXIDE YELLOW 
ETHYLHEXYLGLYCERIN 
EDETATE DISODIUM 
SILICON DIOXIDE 
ADENOSINE 
ALCOHOL 
GREEN TEA LEAF 
HYALURONATE SODIUM 
.BETA.-CAROTENE 
PROPANEDIOL 
Packaging
#Item CodePackage Description
1NDC:43419-304-0335 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 BASE NATURAL GREEN 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-305
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE2.45 g  in 35 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.581 g  in 35 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.686 g  in 35 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
PHENYL TRIMETHICONE 
BUTYLENE GLYCOL 
TRIETHYLHEXANOIN 
NEOPENTYL GLYCOL DIHEPTANOATE 
ARBUTIN 
DIMETHICONE 
SQUALANE 
SODIUM CHLORIDE 
PHENOXYETHANOL 
ALUMINUM HYDROXIDE 
CALCIUM STEARATE 
CAPRYLYL GLYCOL 
STEARIC ACID 
SORBITAN SESQUIOLEATE 
GLYCERIN 
TRIETHOXYCAPRYLYLSILANE 
FERRIC OXIDE YELLOW 
ETHYLHEXYLGLYCERIN 
EDETATE DISODIUM 
SILICON DIOXIDE 
ADENOSINE 
ALCOHOL 
GREEN TEA LEAF 
HYALURONATE SODIUM 
.BETA.-CAROTENE 
CHROMIC OXIDE 
ULTRAMARINE BLUE 
PROPANEDIOL 
Packaging
#Item CodePackage Description
1NDC:43419-305-0335 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(43419-304, 43419-305)

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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