AMOREPACIFIC RESORT COLLECTION SUN PROTECTION MIST- homosalate, octocrylene, octisalate, and avobenzone spray 
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 Mist

Drug Facts

ACTIVE INGREDIENTS

AVOBENZONE 3%
HOMOSALATE 14%
OCTISALATE 4.5%
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 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

ALCOHOL, C12-15 ALKYL BENZOATE, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, PHYLLOSTACHIS BAMBUSOIDES JUICE, TRICHOLOMA MATSUTAKE EXTRACT, PRUNUS MUME FRUIT EXTRACT, PORTULACA OLERACEA EXTRACT, ACRYLATES/OCTYLACRYLAMIDE COPOLYMER, BUTYLENE GLYCOL, FRAGRANCE

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 200 ml Bottle Carton

RESORT COLLECTION
Sun Protection Mist
Broad Spectrum
SPF 30
SUNSCREEN

AMOREPACIFIC

6.76 FL. OZ./200 ml e

PRINCIPAL DISPLAY PANEL - 200 ml Bottle Carton
AMOREPACIFIC RESORT COLLECTION SUN PROTECTION MIST 
homosalate, octocrylene, octisalate, and avobenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-522
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE28000 mg  in 200 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE18000 mg  in 200 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE9000 mg  in 200 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE6000 mg  in 200 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP)  
PRUNUS MUME FRUIT (UNII: 639190I8CU)  
PURSLANE (UNII: M6S840WXG5)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-522-311 in 1 CARTON02/13/201508/01/2018
1200 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:43419-522-381 in 1 CARTON08/01/201808/31/2019
280 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:43419-522-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/201810/22/2020
4NDC:43419-522-371 in 1 CARTON08/01/201810/22/2020
4200 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/13/201510/22/2020
Labeler - AMOREPACIFIC CORPORATION (631035289)
Establishment
NameAddressID/FEIBusiness Operations
AMOREPACIFIC CORPORATION694894112manufacture(43419-522)

Revised: 12/2019
Document Id: 99713420-e827-fdd8-e053-2995a90aeb77
Set id: 253296db-238f-47bf-a147-7f20b2a8702b
Version: 7
Effective Time: 20191211
 
AMOREPACIFIC CORPORATION