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NDC 72330-0601-03 OHUI Ultimate Cover CC Cushion Compact 02 Natural Beige .405; .819 g/15g; g/15g Details

OHUI Ultimate Cover CC Cushion Compact 02 Natural Beige .405; .819 g/15g; g/15g

OHUI Ultimate Cover CC Cushion Compact 02 Natural Beige is a TOPICAL POWDER in the HUMAN OTC DRUG category. It is labeled and distributed by fmg Co.Ltd. The primary component is ENSULIZOLE; TITANIUM DIOXIDE.

Product Information

NDC	72330-0601
Product ID	72330-601_d307b366-b9b7-1d68-e053-2995a90af94e
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	OHUI Ultimate Cover CC Cushion Compact 02 Natural Beige
Proprietary Name Suffix	n/a
Non-Proprietary Name	Titanium Dioxide
Product Type	HUMAN OTC DRUG
Dosage Form	POWDER
Route	TOPICAL
Active Ingredient Strength	.405; .819
Active Ingredient Units	g/15g; g/15g
Substance Name	ENSULIZOLE; TITANIUM DIOXIDE
Labeler Name	fmg Co.Ltd
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 72330-0601-03 (72330060103)

Pricing Information	N/A
NDC Package Code	72330-601-03
Billing NDC	72330060103
Package	3 CONTAINER in 1 CARTON (72330-601-03) / 15 g in 1 CONTAINER
Marketing Start Date	2016-01-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d3078dd2-ae9e-d81a-e053-2a95a90a47bf Details

ACTIVE INGREDIENTS

ENSULIZOLE 2.7%, TITANIUM DIOXIDE 5.46%

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 exposure.

Warnings

For external use only. Do not use on damaged or broken skin. When using this product: Keep out of the 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. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regulary 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. to 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water

INACTIVE INGREDIENTS

WATER, TRIETHYLHEXANOIN, DIMETHICONE, PHENYL TRIMETHICONE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, CYCLOPENTASILOXANE, DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS, CETYL PEG/PPG-10/1 DIMETHICONE, NIACINAMIDE, TROMETHAMINE, 1,2-HEXANEDIOL, SORBITAN SESQUIOLEATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SODIUM CHLORIDE, ZINC STEARATE, PEG-30 DIPOLYHYDROXYSTEARATE, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, STEARIC ACID, DISTEARYLDIMONIUM CHLORIDE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, PALMITOYL PROLINE, PHENOXY ETHANOL, ADENOSINE, BIOSACCHARIDE GUM-1, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM PALMITOYL GLUTAMATE, SODIUM PALMITOYL SARCOSINATE, PALMITIC ACID, DIPROPYLENE GLYCOL, LUFFA CYLINDRICA FRUIT EXTRACT, HEXYL LAURATE, SODIUM CITRATE, POLYGLYCERYL-4 ISOSTEARATE, TOCOPHEROL, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA, IRON OXIDES(CI 77492), IRON OXIDES(CI 77491), IRON OXIDES(CI 77499)

PRINCIPAL DISPLAY PANEL

O HUI

ULTIMATE COVER

CC CUSHION COMPACT

Sunscreen

Broad Spectrum SPF 50

Net Wt. 1.58 oz / 45 g (15 g x 3)

INGREDIENTS AND APPEARANCE

OHUI ULTIMATE COVER CC CUSHION COMPACT 02 NATURAL BEIGE

titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72330-601
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.819 g in 15 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	0.405 g in 15 g

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC STEARATE (UNII: H92E6QA4FV)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PALMITIC ACID (UNII: 2V16EO95H1)
NIACINAMIDE (UNII: 25X51I8RD4)
TROMETHAMINE (UNII: 023C2WHX2V)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PALMITOYL PROLINE (UNII: I49727TDYF)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
STEARIC ACID (UNII: 4ELV7Z65AP)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS (UNII: D818OLQ51Z)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ADENOSINE (UNII: K72T3FS567)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM PALMITOYL GLUTAMATE (UNII: DH37YM1F48)
SODIUM PALMITOYL SARCOSINATE (UNII: 7297LY09YF)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
LUFFA AEGYPTIACA FRUIT (UNII: QKL9NEO1F9)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72330-601-03	3 in 1 CARTON	01/25/2016
1		15 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/25/2016

Labeler - fmg Co.Ltd (690188305)

Name	Address	ID/FEI	Business Operations
Establishment
fmg Co.Ltd		690188305	manufacture(72330-601)

Revised: 12/2021

Document Id: d307b366-b9b7-1d68-e053-2995a90af94e

Set id: d3078dd2-ae9e-d81a-e053-2a95a90a47bf

Version: 1

Effective Time: 20211213