IOPE UV DEFENSE SUN PROTECTOR- homosalate, octocrylene, octisalate, avobenzone cream

IOPE UV DEFENSE SUN PROTECTOR by

Drug Labeling and Warnings

IOPE UV DEFENSE SUN PROTECTOR by is a Otc medication manufactured, distributed, or labeled by AMOREPACIFIC CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 2.5%

Homosalate 9%

Octisalate 4.5%

Octocrylene 9%

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 externel 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure.

Children under 6 months of age: Ask a doctor.

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.

Other information

Protect the product in this container from excessive heat and direct sun.

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

WATER, BUTYLENE GLYCOL,GLYCERIN, BUTYLOCTYL SALICYLATE, CETEARYL ALCOHOL, PHENYL TRIMETHICONE, CAPRYLYL METHICONE, POTASSIUM CETYL PHOSPHATE, CETEARYL GLUCOSIDE, 1,2-HEXANEDIOL, SODIUM POLYACRYLOYLDIMETHYL, TAURATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER,
FRAGRANCE / PARFUM, TOCOPHEROL, GLYCERYL CAPRYLATE, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, LIMONENE, SORBITAN ISOSTEARATE, LINALOOL, GLUCOSE, CITRONELLOL, HEXYL CINNAMAL, FERULIC ACID

Questions?

support@us.amorepacific.com

IOPE UV Defense Sun Protector Sunscreen

IOPE

UV DEFENSE

SUN PROTECTOR

SUNSCREEN

BROAD SPECTRUM SPF45

50 mL / 1.69 fl. oz.

INGREDIENTS AND APPEARANCE

IOPE UV DEFENSE SUN PROTECTOR 
homosalate, octocrylene, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.5 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4.5 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
WATER (UNII: 059QF0KO0R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SODIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: NG5NG5733T)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TOCOPHEROL (UNII: R0ZB2556P8)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
FERULIC ACID (UNII: AVM951ZWST)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-420-08	1 in 1 BOX	03/01/2024
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2024

Labeler - AMOREPACIFIC CORPORATION (631035289)