Search by Drug Name or NDC

NDC 43526-0120-02 IPKN Pore Apple Sun Block 2.72; 1.8; .996; 1.92 mg/40mL; mg/40mL; mg/40mL; mg/40mL Details

IPKN Pore Apple Sun Block 2.72; 1.8; .996; 1.92 mg/40mL; mg/40mL; mg/40mL; mg/40mL

IPKN Pore Apple Sun Block is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Inel Cosmetics Co., Ltd. The primary component is OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	43526-0120
Product ID	43526-120_1825b9e0-98ff-4f64-90e2-b8bc58848994
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	IPKN Pore Apple Sun Block
Proprietary Name Suffix	n/a
Non-Proprietary Name	OCTINOXATE, ZINC OXIDE, OCTISALATE, TITANIUM DIOXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	2.72; 1.8; .996; 1.92
Active Ingredient Units	mg/40mL; mg/40mL; mg/40mL; mg/40mL
Substance Name	OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	Inel Cosmetics Co., Ltd
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2022-12-31

Package

Package Images

NDC 43526-0120-02 (43526012002)

Pricing Information	N/A
NDC Package Code	43526-120-02
Billing NDC	43526012002
Package	1 CONTAINER in 1 CARTON (43526-120-02) / 40 mL in 1 CONTAINER (43526-120-01)
Marketing Start Date	2018-01-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a9e1dac8-6cb8-4f78-9b48-9b615f5972b5 Details

SPL UNCLASSIFIED SECTION

Ethylhexyl Methoxycinnamate 6.80%

Zinc Oxide 4.80%

Ethylhexyl Salicylate 4.50%

Titanium Dioxide 2.49%

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if rash occurs.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Do not use on damaged or broken skin.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/31/2018

Labeler - Inel Cosmetics Co., Ltd (688038939)

Registrant - Inel Cosmetics Co., Ltd (688038939)

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

Revised: 1/2018

Document Id: 1825b9e0-98ff-4f64-90e2-b8bc58848994

Set id: a9e1dac8-6cb8-4f78-9b48-9b615f5972b5

Version: 5

Effective Time: 20180131

Search by Drug Name or NDC

NDC 43526-0120-02 IPKN Pore Apple Sun Block 2.72; 1.8; .996; 1.92 mg/40mL; mg/40mL; mg/40mL; mg/40mL Details

IPKN Pore Apple Sun Block 2.72; 1.8; .996; 1.92 mg/40mL; mg/40mL; mg/40mL; mg/40mL

Product Information

Package

Package Images

NDC 43526-0120-02 (43526012002)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a9e1dac8-6cb8-4f78-9b48-9b615f5972b5 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

INSTRUCTIONS FOR USE

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

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