AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102- zinc oxide, octinoxate, and titanium dioxide lotion

AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102 by

Drug Labeling and Warnings

AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102 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

ETHYLHEXYL METHOXYCINNAMATE 7%

TITANIUM DIOXIDE 4.15%

ZINC OXIDE 9.8%

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

PHYLLOSTACHIS BAMBUSOIDES JUICE, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, PEG-10 DIMETHICONE, PHENYL TRIMETHICONE, BUTYLENE GLYCOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, ALCOHOL, ARBUTIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, POLYHYDROXYSTEARIC ACID, SODIUM CHLORIDE, POLYMETHYL METHACRYLATE, ALUMINUM HYDROXIDE, STEARIC ACID, DISTEARDIMONIUM HECTORITE, TRIETHOXYCAPRYLYLSILANE, ETHYLHEXYL PALMITATE, LECITHIN, ISOSTEARIC ACID, ISOPROPYL PALMITATE, PHENOXYETHANOL, POLYGLYCERYL-3 POLYRICINOLEATE, ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, DIMETHICONE, DISODIUM EDTA, TRIMETHYLSILOXYSILICATE, ETHYLHEXYLGLYCERIN, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, AQUA/WATER/EAU, SILICA, CAMELLIA JAPONICA SEED OIL, CAMELLIA SINENSIS LEAF EXTRACT, CAPRYLYL GLYCOL, 1,2-HEXANEDIOL, PARFUM/FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES (CI 77492, CI 77491, CI 77499)

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 30 g (15 g x 2) Container Carton

COLOR CONTROL CUSHION COMPACT

Broad Spectrum SPF 50+
Sunscreen

AMOREPACIFIC

Net Wt. 1.05 OZ./30 g(15 gx2) e

INGREDIENTS AND APPEARANCE

AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102 
zinc oxide, octinoxate, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-528
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.94 g  in 30 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.1 g  in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.245 g  in 30 g

Inactive Ingredients
Ingredient Name	Strength
PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
ALCOHOL (UNII: 3K9958V90M)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISOSTEARIC ACID (UNII: X33R8U0062)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-528-31	2 in 1 CARTON	06/05/2017
1		15 g in 1 CONTAINER; Type 7: Separate Products Requiring Cross Labeling

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/26/2016

Labeler - AMOREPACIFIC CORPORATION (631035289)

Establishment
Name	Address	ID/FEI	Business Operations
AMOREPACIFIC CORPORATION		694894112	MANUFACTURE(43419-528)