BELIF MOISTURIZING BOMB CUSHION COMPACT - NATURAL BEIGE- ensulizole, titanium dioxide powder

belif Moisturizing bomb cushion compact - natural beige by

Drug Labeling and Warnings

belif Moisturizing bomb cushion compact - natural beige by is a Otc medication manufactured, distributed, or labeled by LG Household and Health Care Inc, ZENISCE Co.Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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), may decrease 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 the eyes. Rinse with water to remove.

Stop use and ask doctor, if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or

contact a Posion 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, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and othersun protection measures including:

- Limit time in the sun, especially from 10 a.m. to 2 p.m.

- Wear longsleeved shirts, pants, hats, and sunglasses.

• Children under 6 months: Ask a doctor.

OTHER INFORMATION

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

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, PEG-30 DIPOLYHYDROXYSTEARATE, SODIUM CHLORIDE, ZINC STEARATE, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, STEARIC ACID, DISTEARYLDIMONIUM CHLORIDE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, TRIETHOXYSILYLETHYL, POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, PALMITOYL PROLINE, ADENOSINE, BIOSACCHARIDE GUM-1, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM PALMITOYL GLUTAMATE, SODIUM PALMITOYL SARCOSINATE, PALMITIC ACID, DIPROPYLENE GLYCOL, LUFFA CYLINDRICA FRUIT EXTRACT, HEXYL LAURATE, POLYGLYCERYL-4 ISOSTEARATE, SODIUM CITRATE, TOCOPHEROL, FRAGRANCE*, TITANIUM DIOXIDE(CI 77891), MICA, IRON OXIDES(CI 77492), IRON OXIDES(CI 77491), IRON OXIDES(CI 77499)

DOSAGE & ADMINISTRATION

INDICATIONS & USAGE

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL - 30 g (15 g x 2) Natural Beige

Moisturizing bomb cushion compact - natural beige

Provides moisture & coverage for up to 26 hrs.*

Dermatologically tested

Sunscreen Broad Spectrum SPF 50

Net Wt. 1.04 oz / 30 g (15g x 2)

INGREDIENTS AND APPEARANCE

BELIF MOISTURIZING BOMB CUSHION COMPACT - NATURAL BEIGE 
ensulizole, titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53208-701
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53208-701-01	3 in 1 CARTON	01/01/2017
1		15 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2017

Labeler - LG Household and Health Care Inc (688276187)

Establishment
Name	Address	ID/FEI	Business Operations
LG Household and Health Care Inc		688276187	manufacture(53208-701)

Establishment
Name	Address	ID/FEI	Business Operations
ZENISCE Co.Ltd.		690188305	manufacture(53208-701)