AMOREPACIFIC NATURAL PROTECTOR- avobenzone, homosalate, octisalate, and octocrylene cream 
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 Natural Protector

Drug Facts

ACTIVE INGREDIENTS W/W

AVOBENZONE 2.5%
HOMOSALATE 9%
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 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 waterresistant 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, PROPANEDIOL, BUTYLOCTYL SALICYLATE, ALCOHOL, CYCLOPENTASILOXANE, DIMETHICONE, CYCLOHEXASILOXANE, C14-22 ALCOHOLS, PEG-100 STEARATE, GLYCERYL STEARATE, BEHENYL ALCOHOL, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, FRAGRANCE/PARFUM, POLYACRYLATE-13, C12-20 ALKYL GLUCOSIDE, POLYISOBUTENE, WATER, PORTULACA OLERACEA EXTRACT, PRUNUS MUME FRUIT EXTRACT, DISODIUM EDTA, BUTYLENE GLYCOL, POLYSORBATE 20, CAMELLIA SINENSIS LEAF EXTRACT, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 60 ml Tube Carton

NATURAL PROTECTOR
Broad Spectrum SPF 35
Sunscreen

AMOREPACIFIC

2.02 FL. OZ./60 ml e

PRINCIPAL DISPLAY PANEL - 60 ml Tube Carton
AMOREPACIFIC NATURAL PROTECTOR 
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-580
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1500 mg  in 60 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5400 mg  in 60 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2700 mg  in 60 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5400 mg  in 60 mL
Inactive Ingredients
Ingredient NameStrength
PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP)  
PROPANEDIOL (UNII: 5965N8W85T)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ALCOHOL (UNII: 3K9958V90M)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
C14-22 ALCOHOLS (UNII: B1K89384RJ)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DOCOSANOL (UNII: 9G1OE216XY)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
WATER (UNII: 059QF0KO0R)  
PURSLANE (UNII: M6S840WXG5)  
PRUNUS MUME FRUIT (UNII: 639190I8CU)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-580-181 in 1 CARTON01/18/201605/30/2020
160 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:43419-580-2430 mL in 1 TUBE; Type 0: Not a Combination Product08/01/201805/30/2020
3NDC:43419-580-145 mL in 1 TUBE; Type 0: Not a Combination Product08/01/201805/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/18/201605/30/2020
Labeler - AMOREPACIFIC CORPORATION (631035289)
Establishment
NameAddressID/FEIBusiness Operations
AMOREPACIFIC CORPORATION694894112manufacture(43419-580)

Revised: 12/2019
 
AMOREPACIFIC CORPORATION