IOPE UV DEFENSE SUN PROTECTOR EX- avobenzone, homosalate, octocrylene, octisalate lotion lotion

IOPE UV DEFENSE SUN PROTECTOR EX by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENTS

Avobenzone 2.5%
Homosalate 9%
Octocrylene 9%
Octisalate 4.5%

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 swallowed, call a poison control centre or get medical help 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 / Aqua / Eau, Propanediol, Butyloctyl salicylate, Glycerin, Butylene glycol dicaprylate/dicaprate, Diphenylsiloxy
phenyl trimethicone, Dimethicone, Trisiloxane, Silica, Cyclopentasiloxane, Trimethylsiloxysilicate, VP/Eicosene copolymer, 1,2-Hexanediol, Behenyl alcohol, Glyceryl stearate, PEG-100 stearate, C14-22 Alcohols, Polyacrylate-13, Cetyl alcohol, Potassium cetyl phosphate, Fragrance / Parfum, Polyisobutene, C12-20 Alkyl glucoside, Butylene glycol, Disodium EDTA, Ethylhexy glycerin, Polysorbate 20, Sorbitan isostearate, Gossypium herbaceum (cotton) extract, Glucose, Tocopherol

Questions?

support@us.amorepacific.com

PRINCIPAL DISPLAY PANEL

IOPE

UV DEFENSE

SUN PROTECTOR EX

SUNSCREEN

BROAD SPECTRUM SPF39

60 ml / 2.02 FL. OZ.

INGREDIENTS AND APPEARANCE

IOPE UV DEFENSE SUN PROTECTOR EX 
avobenzone, homosalate, octocrylene, octisalate lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-418
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 mg  in 60 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.7 mg  in 60 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5.4 mg  in 60 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5.4 mg  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRISILOXANE (UNII: 9G1ZW13R0G)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYISOBUTYLENE (1100000 MW) (UNII: FLT10CH37X)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPANEDIOL (UNII: 5965N8W85T)
DOCOSANOL (UNII: 9G1OE216XY)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LEVANT COTTON SEED (UNII: 550E4N439V)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
TOCOPHEROL (UNII: R0ZB2556P8)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-418-18	1 in 1 CARTON	04/27/2020
1		60 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 not final	part352	04/27/2020

Labeler - Amorepacific Corporation (631035289)

Establishment
Name	Address	ID/FEI	Business Operations
Amorepacific Corporation		694894112	manufacture(43419-418)