AMOREPACIFIC RESORT COLLECTION SUN PROTECTION- homosalate, octocrylene, octisalate, and avobenzone stick 
AMOREPACIFIC CORPORATION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Amorepacific Resort Collection Sun Protection Stick

Drug Facts

ACTIVE INGREDIENTS

BUTYL METHOXYDIBENZOYLMETHANE 3%
ETHYLHEXYL SALICYLATE 4.5%
HOMOSALATE 9%
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 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 medicalhelp 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

POLYETHYLENE, ISOPROPYL PALMITATE, POLYMETHYLSILSESQUIOXANE, PHENYL TRIMETHICONE, SQUALANE, BUTYLOCTYL SALICYLATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX, RICINUS COMMUNIS (CASTOR) SEED OIL, PHYLLOSTACHIS BAMBUSOIDES JUICE, PORTULACA OLERACEA EXTRACT, PRUNUS MUME FRUIT EXTRACT, CAMELLIA SINENSIS SEED OIL, GLYCERYL CAPRYLATE, BUTYLENE GLYCOL, ALCOHOL, FRAGRANCE

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 7 g Stick Carton

RESORT COLLECTION
Sun Protection Stick
Broad Spectrum
SPF 50+
SUNSCREEN

AMOREPACIFIC

NET WT. 0.24 OZ./7 g e

Principal Display Panel - 7 g Stick Carton
AMOREPACIFIC RESORT COLLECTION SUN PROTECTION 
homosalate, octocrylene, octisalate, and avobenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-521
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.63 g  in 7 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.63 g  in 7 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.315 g  in 7 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.21 g  in 7 g
Inactive Ingredients
Ingredient NameStrength
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SQUALANE (UNII: GW89575KF9)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
CASTOR OIL (UNII: D5340Y2I9G)  
PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP)  
PURSLANE (UNII: M6S840WXG5)  
PRUNUS MUME FRUIT (UNII: 639190I8CU)  
CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-521-311 in 1 CARTON02/13/201507/31/2018
17 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/13/201507/31/2018
Labeler - AMOREPACIFIC CORPORATION (631035289)
Establishment
NameAddressID/FEIBusiness Operations
AMOREPACIFIC687995683MANUFACTURE(43419-521)

Revised: 8/2018
 
AMOREPACIFIC CORPORATION