FDA.reportPublic FDA data

Amorepacific Resort Collection Sun Protection Cushion

Manufacturer
AMOREPACIFIC CORPORATION
Effective date
2019-12-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:52:47

Label at a glance#

ProductAmorepacific Resort Collection Sun Protection Cushion
Active ingredientOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Indications and 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.

Dosage and administration

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, especial...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ETHYLHEXYL METHOXYCINNAMATE 7%
TITANIUM DIOXIDE 4.15%
ZINC OXIDE 9.8%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • For external use only.

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

  • When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL - 15 g Container Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RESORT COLLECTION
Sun Protection Cushion
Broad Spectrum SPF 30+
SUNSCREEN

AMOREPACIFIC

Net Wt. 0.52 OZ./15 g e

Principal Display Panel - 15 g Container Carton
Principal Display Panel - 15 g Container Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP2
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN02
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATEINACTIVE INGREDIENT75D21FL1PI2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U2
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R2
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BA2
DISTEARDIMONIUM HECTORITEINACTIVE INGREDIENTX687XDK09L2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT28659933092
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6752
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3572
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63M2
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U00622
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONEINACTIVE INGREDIENT25G622K2RA2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4R2
PHYLLOSTACHYS RETICULATA RESININACTIVE INGREDIENTKX390ME4SP2
PRUNUS MUME FRUITINACTIVE INGREDIENT639190I8CU2
PURSLANEINACTIVE INGREDIENTM6S840WXG52
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43419-52043419-520-31

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHYLLOSTACHYS RETICULATA RESINKX390ME4SPIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 6XHK3U310BAIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE75D21FL1PIIACT
ALCOHOL3K9958V90MIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
SODIUM CHLORIDE451W47IQ8XIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
ETHYLHEXYL PALMITATE2865993309IACT
ISOSTEARIC ACIDX33R8U0062IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
EDETATE DISODIUM7FLD91C86KIACT
FERRIC OXIDE RED1K09F3G675IACT
PURSLANEM6S840WXG5IACT
PRUNUS MUME FRUIT639190I8CUIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 373 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRALESIONAL13 mgExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCREAM / TOPICAL0.4 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSYSTEM / IONTOPHORESIS3.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
21 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
26 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGRANULE, FOR SUSPENSION / ORAL162 mgExact identifier — unii candidate
134 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii candidate
21 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / ORALNAExact identifier — unii candidate
26 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOAP / TOPICAL6 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MGEL / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET / ORAL231 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSPRAY / NASAL30 mgExact identifier — unii candidate
134 equally ranked IID candidates
ISOSTEARIC ACIDISOSTEARIC ACIDX33R8U0062CREAM / TOPICAL100 mgExact identifier — unii candidate
3 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APIMPLANT / SUBCUTANEOUS1.04 mgExact identifier — unii candidate
26 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRALESIONAL0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRA-ARTERIAL278 mgExact identifier — unii candidate
134 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED / ORAL0.12 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVENOUS2916 mgExact identifier — unii candidate
134 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAVITREAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, EFFERVESCENT / ORAL32 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPOWDER, FOR SUSPENSION / ORAL1203 mg/5mlExact identifier — unii candidate
26 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION/ DROPS / AURICULAR (OTIC)3 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSYSTEM / TOPICAL3.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
77 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MAEROSOL / TOPICAL397 mgExact identifier — unii candidate
8 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / ORAL1126 mgExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / EPIDURAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / IONTOPHORESIS0.1 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / ORALNAExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINHALANT / RESPIRATORY (INHALATION)3 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / RECTALNAExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAVENOUS6320 mgExact identifier — unii candidate
134 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
20 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MOINTMENT / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, COATED / ORAL0.21 mgExact identifier — unii candidate
77 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, DELAYED RELEASE / ORAL7 mgExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / EPIDURAL3535 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAMUSCULAR90 mgExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / NASAL100 mg/100mlExact identifier — unii candidate
77 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii candidate
26 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR226 mgExact identifier — unii candidate
134 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
26 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / ORAL148 mgExact identifier — unii candidate
134 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
99711363-fc99-3acf-e053-2a95a90a0435423b42f7-8799-4082-bf3a-182c062f1a5b2019-12-11WarningsExact identifier
spl id: 99711363-fc99-3acf-e053-2a95a90a0435
spl set id: 423b42f7-8799-4082-bf3a-182c062f1a5b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.