INTENSE UV PROTECTION CREAM- zinc oxide, octinoxate, octisalate, and titanium dioxide lotion

intense UV protection cream by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Octinoxate (6.8%)	Sunscreen
Octisalate (4.5%)	Sunscreen
Titanium Dioxide (4.0006%)	Sunscreen
Zinc Oxide (12.6616%)	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, cyclopentasiloxane, peg-10 dimethicone, dipropylene glycol, butyloctyl salicylate, glycerin, dicaprylyl carbonate, caprylyl methicone, mica (CI 77019), disteardimonium hectorite, silica, vinyl dimethicone/methicone silsesquioxane crosspolymer, magnesium sulfate, aluminum hydroxide, stearic acid, phenoxyethanol, triethoxycaprylylsilane, fragrance, propanediol, polyglyceryl-3 polydimethylsiloxyethyl dimethicone, sorbitan caprylate, octyldodecanol, phenyl trimethicone, dimethicone crosspolymer, glyceryl caprylate, ethylhexylglycerin, iron oxides (CI 77492), centella asiatica extract, portulaca oleracea extract, echium plantagineum seed oil, iron oxides (CI 77491), butylene glycol, iron oxides (CI 77499), camellia sinensis leaf extract, helianthus annuus (sunflower) seed oil unsaponifiables, cardiospermum halicacabum flower/leaf/vine extract, tocopherol, helianthus annuus (sunflower) seed oil, 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 Container Carton

innisfree

intense UV protection
cream
broad spectrum SPF 50+

1.69 FL.OZ./ 50 ml

INGREDIENTS AND APPEARANCE

INTENSE UV PROTECTION CREAM 
zinc oxide, octinoxate, octisalate, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71220-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12.6616 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.8 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.0006 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
MICA (UNII: V8A1AW0880)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
PURSLANE (UNII: M6S840WXG5)
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71220-011-09	1 in 1 CARTON	05/13/2017
1		50 mL in 1 CONTAINER; 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	05/13/2017

Labeler - Innisfree Corporation (557822425)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea		689512611	MANUFACTURE(71220-011)