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

  • NDC Code(s): 53208-701-01
  • Packager: LG Household and Health Care Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 1, 2017

If you are a consumer or patient please visit this version.

  • 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

    PDPMoisturizing 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.819 g  in 15 g
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE0.405 g  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-701-013 in 1 CARTON01/01/2017
    115 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2017
    Labeler - LG Household and Health Care Inc (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    LG Household and Health Care Inc688276187manufacture(53208-701)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZENISCE Co.Ltd.690188305manufacture(53208-701)