INTENSE UV PROTECTION EMULSION- homosalate, octinoxate, octocrylene, octisalate, and avobenzone lotion

intense UV protection emulsion by

Drug Labeling and Warnings

intense UV protection emulsion by is a Otc medication manufactured, distributed, or labeled by Innisfree Corporation, Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone (2.9%)	Sunscreen
Homosalate (9.0%)	Sunscreen
Octinoxate (6.8%)	Sunscreen
Octisalate (4.5%)	Sunscreen
Octocrylene (5.0%)	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

WATER, PROPANEDIOL, METHYL METHACRYLATE CROSSPOLYMER, 1,2-HEXANEDIOL, STYRENE/ACRYLATES COPOLYMER, FRAGRANCE, CETETH-10, PHENOXYETHANOL, CETYL ALCOHOL, POLYACRYLATE CROSSPOLYMER-6, PENTYLENE GLYCOL, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SACCHARIDE HYDROLYSATE, OCTYLDODECANOL, CARBOMER, TROMETHAMINE, ETHYLHEXYLGLYCERIN, CENTELLA ASIATICA EXTRACT, PORTULACA OLERACEA EXTRACT, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, SALVIA HISPANICA SEED EXTRACT, ECHIUM PLANTAGINEUM SEED OIL, BUTYLENE GLYCOL, T-BUTYL ALCOHOL, CAMELLIA SINENSIS LEAF EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, TOCOPHEROL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, GLYCERIN, HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF EXTRACT, CITRUS UNSHIU PEEL EXTRACT, OPUNTIA COCCINELLIFERA FRUIT EXTRACT, ORCHID EXTRACT, CAMELLIA JAPONICA LEAF EXTRACT, CITRIC ACID, SODIUM BENZOATE, POTASSIUM SORBATE

Other information

• protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

innisfree

intense UV protection
emulsion

broad spectrum SPF 50+

1.69 FL.OZ./ 50 ml

INGREDIENTS AND APPEARANCE

INTENSE UV PROTECTION EMULSION 
homosalate, octinoxate, octocrylene, octisalate, and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71220-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4.5 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.4 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.5 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.45 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
propanediol (UNII: 5965N8W85T)
1,2-hexanediol (UNII: TR046Y3K1G)
ceteth-10 (UNII: LF9X1PN3XJ)
phenoxyethanol (UNII: HIE492ZZ3T)
cetyl alcohol (UNII: 936JST6JCN)
pentylene glycol (UNII: 50C1307PZG)
invert sugar (UNII: ED959S6ACY)
octyldodecanol (UNII: 461N1O614Y)
carboxypolymethylene (UNII: 0A5MM307FC)
tromethamine (UNII: 023C2WHX2V)
ethylhexylglycerin (UNII: 147D247K3P)
Centella Asiatica (UNII: 7M867G6T1U)
Purslane (UNII: M6S840WXG5)
turmeric (UNII: 856YO1Z64F)
chia seed (UNII: NU0OLX06F8)
echium plantagineum seed oil (UNII: PIB7XBU8XW)
butylene glycol (UNII: 3XUS85K0RA)
tert-butyl alcohol (UNII: MD83SFE959)
Green Tea Leaf (UNII: W2ZU1RY8B0)
cardiospermum halicacabum flowering top (UNII: MZP2508BRR)
tocopherol (UNII: R0ZB2556P8)
sunflower oil (UNII: 3W1JG795YI)
glycerin (UNII: PDC6A3C0OX)
hamamelis virginiana leaf (UNII: T07U1161SV)
tangerine peel (UNII: JU3D414057)
opuntia cochenillifera fruit (UNII: 838ZTK02KH)
camellia japonica leaf (UNII: 4E3VE6KTLY)
citric acid monohydrate (UNII: 2968PHW8QP)
sodium benzoate (UNII: OJ245FE5EU)
potassium sorbate (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71220-012-09	1 in 1 CARTON	12/01/2017
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/01/2017

Labeler - Innisfree Corporation (557822425)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	MANUFACTURE(71220-012)