IOPE AIR CUSHION BLUSHER NO 1- octinoxate, titanium dioxide, and zinc oxide lotion IOPE AIR CUSHION BLUSHER NO 2- octinoxate, titanium dioxide, and zinc oxide lotion

IOPE Air Cushion Blusher no 2 by

Drug Labeling and Warnings

IOPE Air Cushion Blusher no 2 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

ETHYLHEXYL METHOXYCINNAMATE 7% / TITANIUM DIOXIDE 1.66% / ZINC OXIDE 1.96 %

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. S un 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.

INACTIVE INGREDIENTS

WATER (MINERAL WATER), CYCLOPENTASILOXANE, PHENYL TRIMETHICONE, CYCLOHEXASILOXANE, PEG-10 DIMETHICONE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, BUTYLENE GLYCOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, PROPANEDIOL, BORON NITRIDE, ARBUTIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, DISTEARDIMONIUM HECTORITE, TITANIUM DIOXIDE (CI 77891), ACRYLATES /ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, POLYHYDROXYSTEARIC ACID, SODIUM CHLORIDE, SYNTHETIC FLUORPHLOGOPITE, MICA (CI 77019), PHENOXYETHANOL, FRAGRANCE, ETHYLHEXYL PALMITATE, ISOPROPYL PALMITATE, ISOSTEARIC ACID, LECITHIN, ALUMINUM HYDROXIDE, POLYMETHYL METHACRYLATE, CAPRYLYL GLYCOL, IRON OXIDES (CI 77491), GLYCERIN, STEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, ETHYLHEXYLGLYCERIN, DIMETHICONE, SILICA, DISODIUM EDTA, TRIETHOXYCAPRYLYLSILANE, TRIMETHYLSILOXYSILICATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, NELUMBO NUCIFERA FLOWER EXTRACT, WATER, PRUNUS MUME FRUIT EXTRACT, TIN OXIDE, LIPASE, CHITOSAN, GLYCOPROTEINS

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 9 g Container Carton - 01 Rosé Pink

IOPE

AIR CUSHION ® BLUSHER
01 ROSÉ PINK

BROAD SPECTRUM
SPF30
SUNSCREEN

Net wt. 0.31 OZ. / 9 g

PRINCIPAL DISPLAY PANEL - 9 g Container Carton - 02 Peach Sherbet

IOPE

AIR CUSHION ® BLUSHER
02 PEACH SHERBET

BROAD SPECTRUM
SPF30
SUNSCREEN

Net wt. 0.31 OZ. / 9 g

INGREDIENTS AND APPEARANCE

IOPE AIR CUSHION BLUSHER NO 1 
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-385
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.63 g  in 9 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.1494 g  in 9 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.1764 g  in 9 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
BORON NITRIDE (UNII: 2U4T60A6YD)
ARBUTIN (UNII: C5INA23HXF)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOSTEARIC ACID (UNII: X33R8U0062)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
PRUNUS MUME FRUIT (UNII: 639190I8CU)
STANNIC OXIDE (UNII: KM7N50LOS6)
PANCRELIPASE LIPASE (UNII: 8MYC33932O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-385-28	1 in 1 CARTON	11/05/2018	01/03/2022
1		9 g in 1 CONTAINER; 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	10/27/2014	01/03/2022

IOPE AIR CUSHION BLUSHER NO 2 
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-386
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.63 g  in 9 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.1494 g  in 9 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.1764 g  in 9 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
ARBUTIN (UNII: C5INA23HXF)
BORON NITRIDE (UNII: 2U4T60A6YD)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MICA (UNII: V8A1AW0880)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOSTEARIC ACID (UNII: X33R8U0062)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
PRUNUS MUME FRUIT (UNII: 639190I8CU)
STANNIC OXIDE (UNII: KM7N50LOS6)
PANCRELIPASE LIPASE (UNII: 8MYC33932O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-386-28	1 in 1 CARTON	11/05/2018	11/26/2021
1		9 g in 1 CONTAINER; 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	10/27/2014	11/26/2021

Labeler - Amorepacific Corporation (631035289)

Establishment
Name	Address	ID/FEI	Business Operations
Amorepacific Corporation		694894112	manufacture(43419-385, 43419-386)