AMOREPACIFIC RESORT COLLECTION SUN PROTECTION CUSHION- octinoxate, titanium dioxide, and zinc oxide lotion

Amorepacific Resort Collection Sun Protection Cushion by

Drug Labeling and Warnings

Amorepacific Resort Collection Sun Protection Cushion 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 4.15%
ZINC OXIDE 9.8%

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

INACTIVE INGREDIENTS

PHYLLOSTACHIS BAMBUSOIDES JUICE, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, PEG-10 DIMETHICONE, PHENYL TRIMETHICONE, BUTYLENE GLYCOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, ALCOHOL, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, POLYHYDROXYSTEARIC ACID, DISTEARDIMONIUM HECTORITE, SODIUM CHLORIDE, ALUMINUM HYDROXIDE, STEARIC ACID, FRAGRANCE, LECITHIN, ETHYLHEXYL PALMITATE, ISOSTEARIC ACID, ISOPROPYL PALMITATE, TRIETHOXYCAPRYLYLSILANE, CAPRYLYL GLYCOL, POLYGLYCERYL-3 POLYRICINOLEATE, PHENOXYETHANOL, IRON OXIDES (CI 77492), ETHYLHEXYLGLYCERIN, DISODIUM EDTA, POLYMETHYL METHACRYLATE, IRON OXIDES (CI 77491), PORTULACA OLERACEA EXTRACT, PRUNUS MUME FRUIT EXTRACT, IRON OXIDES (CI 77499)

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 15 g Container Carton

RESORT COLLECTION
Sun Protection Cushion
Broad Spectrum SPF 30+
SUNSCREEN

AMOREPACIFIC

Net Wt. 0.52 OZ./15 g e

INGREDIENTS AND APPEARANCE

AMOREPACIFIC RESORT COLLECTION SUN PROTECTION CUSHION 
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-520
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.05 g  in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.6225 g  in 15 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.47 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
ALCOHOL (UNII: 3K9958V90M)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISOSTEARIC ACID (UNII: X33R8U0062)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PURSLANE (UNII: M6S840WXG5)
PRUNUS MUME FRUIT (UNII: 639190I8CU)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-520-31	1 in 1 CARTON	02/06/2015	08/01/2020
1		15 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	02/06/2015	08/01/2020

Labeler - AMOREPACIFIC CORPORATION (631035289)

Establishment
Name	Address	ID/FEI	Business Operations
AMOREPACIFIC CORPORATION		694894112	manufacture(43419-520)