IPKN PORE APPLE SUN BLOCK- octinoxate, zinc oxide, octisalate, titanium dioxide cream

IPKN Pore Apple Sun Block by

Drug Labeling and Warnings

IPKN Pore Apple Sun Block by is a Otc medication manufactured, distributed, or labeled by Inel Cosmetics Co., Ltd, Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethylhexyl Methoxycinnamate 6.80%

Zinc Oxide 4.80%

Ethylhexyl Salicylate 4.50%

Titanium Dioxide 2.49%

PURPOSE

Sunscreen

Helps prevent sunburn

INSTRUCTIONS FOR USE

Apply liberally 15 minutes before sun exposure

Reapply at least every two 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 of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10a.m. - 2p.m.
Wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor.

For external use only

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

ASK DOCTOR

Stop use and ask a doctor if rash occurs.

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

DO NOT USE

Do not use on damaged or broken skin.

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

WATER
CYCLOPENTASILOXANE
GLYCERIN
PEG-10 DIMETHICONE
CYCLOMETHICONE
BUTYLOCTYL SALICYLATE
DIPROPYLENE GLYCOL
DISTEARDIMONIUM HECTORITE
MAGNESIUM SULFATE
TALC
DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER
PYRUS MALUS (APPLE) FRUIT EXTRACT
PHENOXYETHANOL
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER
ALUMINUM HYDROXIDE
ALUMINUM STEARATE
METHICONE
CAPRYLYL GLYCOL
FRAGRANCE
GLYCERYL CAPRYLATE
DIMETHICONE
OPUNTIA FICUS-INDICA EXTRACT
POLYGLYCERYL-6 POLYRICINOLEATE
ANTHEMIS NOBILIS FLOWER EXTRACT
FOENICULUM VULGARE (FENNEL) LEAF EXTRACT
LAURUS NOBILIS LEAF EXTRACT
LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER/LEAF/STEM EXTRACT
MENTHA PIPERITA (PEPPERMINT) EXTRACT
ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT
CHROMIUM OXIDE GREENS
VACCINIUM MYRTILLUS FRUIT EXTRACT
SACCHARUM OFFICINARUM (SUGAR CANE) EXTRACT
CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT
CITRUS LIMON (LEMON) FRUIT EXTRACT
ACER SACCHARUM (SUGAR MAPLE) EXTRACT
BELLIS PERENNIS (DAISY) FLOWER EXTRACT
CITRIC ACID
THYMUS VULGARIS (THYME) OIL
VITIS VINIFERA (GRAPE) SEED EXTRACT
OCIMUM BASILICUM (BASIL) LEAF EXTRACT
ORIGANUM MAJORANA LEAF EXTRACT
SALVIA OFFICINALIS (SAGE) LEAF EXTRACT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IPKN PORE APPLE SUN BLOCK 
octinoxate, zinc oxide, octisalate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43526-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.72 mg  in 40 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.92 mg  in 40 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.8 mg  in 40 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.996 mg  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TALC (UNII: 7SEV7J4R1U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
METHICONE (20 CST) (UNII: 6777U11MKT)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
DIMETHICONE (UNII: 92RU3N3Y1O)
OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
FOENICULUM VULGARE LEAF (UNII: 6DR2KY0L5K)
BAY LEAF (UNII: WS0Y3M85RF)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
ROSEMARY (UNII: IJ67X351P9)
CHROMIC OXIDE (UNII: X5Z09SU859)
BILBERRY (UNII: 9P2U39H18W)
SUGARCANE (UNII: 81H2R5AOH3)
ORANGE (UNII: 5EVU04N5QU)
PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)
LEMON (UNII: 24RS0A988O)
ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC)
BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
THYME OIL (UNII: 2UK410MY6B)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
BASIL (UNII: 2U0KZP0FDW)
SWEET MARJORAM OIL (UNII: ICH7BE016E)
SAGE (UNII: 065C5D077J)
APPLE (UNII: B423VGH5S9)
DIPHENYL DIMETHICONE (400 CST) (UNII: Y5MXX82OQ7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43526-120-02	1 in 1 CARTON	01/31/2018
1	NDC: 43526-120-01	40 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 not final	part352	01/31/2018

Labeler - Inel Cosmetics Co., Ltd (688038939)

Registrant - Inel Cosmetics Co., Ltd (688038939)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(43526-120)