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

Amorepacific Natural Protector by

Drug Labeling and Warnings

Amorepacific Natural Protector 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 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

INGREDIENTS AND APPEARANCE

AMOREPACIFIC NATURAL PROTECTOR 
avobenzone, homosalate, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-580
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1500 mg  in 60 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5400 mg  in 60 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2700 mg  in 60 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5400 mg  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-580-18	1 in 1 CARTON	01/18/2016	05/30/2020
1		60 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 43419-580-24	30 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2018	05/30/2020
3	NDC: 43419-580-14	5 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2018	05/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/18/2016	05/30/2020

Labeler - AMOREPACIFIC CORPORATION (631035289)

Establishment
Name	Address	ID/FEI	Business Operations
AMOREPACIFIC CORPORATION		694894112	manufacture(43419-580)