Label: ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 CORAL PETALE- octinoxate, zinc oxide stick
ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 ROSE PARADISE- octinoxate, zinc oxide stick
ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 ROSE COTTON- octinoxate, zinc oxide stick
ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 NUDE TRANSLUCIDE- octinoxate, zinc oxide stick
ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 CERISE BRISE- octinoxate, zinc oxide stick

  • NDC Code(s): 14141-452-01, 14141-453-01, 14141-454-01, 14141-455-01, view more
    14141-456-01
  • Packager: BEL STAR S A
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 28, 2021

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

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose
    Octinoxate 7.50%.............Sunscreen
    Zinc oxide 4.90 %........... Sunscreen

  • PURPOSE

    Uses

    • Helps prevent sunburn.
  • 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.
  • INDICATIONS & USAGE

    • Stop use and ask a doctor if rash occurs.
  • WARNINGS

    Warnings

    • Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
    • For external use only.
    • Do not use on damaged or broken skin.
    • When using this product keep out of eyes. Rinse with water to remove.
  • DOSAGE & ADMINISTRATION

    Directions

    • Apply liberally and evenly 15 minutes before sun exposure.
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age: Ask a doctor
  • OTHER SAFETY INFORMATION

    Other Information

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

  • INACTIVE INGREDIENT

    Inactive ingredients: octyldodecanol, ethylhexyl palmitate, polyethylene, ozokerite, silica, jojoba esters, copernicia cerifera (carnauba) wax, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, helianthus annuus (sunflower) seed wax, hexyl laurate, tocopheryl acetate, dipentaerythrityl hexacaprylate/hexacaprate, tridecyl trimellitate, schinus terebinthifolia seed extract, phenoxyethanol, tridecyl stearate, dimethicone, acacia decurrens flower wax, polyglycerin-3, triethoxycaprylylsilane, neopentyl glycol dicaprylate/dicaprate, caprylyl glycol, chlorphenesin, trimethylsiloxysilicate, ceramide np, lecithin.
    may contain:
    mica, titanium dioxide, synthetic fluorphlogopite, iron oxides, yellow 5 lake, red 7 lake, red 6 lake, talc.

  • Ultra Balm SPF 20 Nude Translucide

    L'BEL ULTRA BALM Moisturizing Protective Balm for lips SPF 20 Nude Translucide

    Net. Wt. 0.14 oz (4 g)

    Nude Translucide

  • Ultra Balm SPF 20 Coral Petal

    L'BEL ULTRA BALM Moisturizing Protective Balm for lips SPF 20 Coral Petale

    Net. Wt. 0.14 oz (4 g)

    Coral Petale

  • Ultra Balm SPF 20 Rose Paradise

    L'BEL ULTRA BALM Moisturizing Protective Balm for lips SPF 20 Rose Paradise

    Net. Wt. 0.14 oz (4 g)

    Rose Paradise

  • Ultra Balm SPF 20 Rose Cotton

    L'BEL ULTRA BALM Moisturizing Protective Balm for lips SPF 20 Rose Cotton

    Net. Wt. 0.14 oz (4 g)

    Rose Cotton

  • Ultra Balm SPF 20 Cerise Brise

    L'BEL ULTRA BALM Moisturizing Protective Balm for lips SPF 20 Cerise Brise

    Net. Wt. 0.14 oz (4 g)

    Cerise Brise

  • INGREDIENTS AND APPEARANCE
    ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 CORAL PETALE 
    octinoxate, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-453
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BRAZILIAN PEPPER (UNII: SUG822G7CD)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    CERAMIDE NP (UNII: 4370DF050B)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-453-014 g in 1 CARTON; Type 0: Not a Combination Product06/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/15/2021
    ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 ROSE PARADISE 
    octinoxate, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-455
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BRAZILIAN PEPPER (UNII: SUG822G7CD)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    CERAMIDE NP (UNII: 4370DF050B)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-455-014 g in 1 CARTON; Type 0: Not a Combination Product06/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/15/2021
    ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 ROSE COTTON 
    octinoxate, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-454
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BRAZILIAN PEPPER (UNII: SUG822G7CD)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    CERAMIDE NP (UNII: 4370DF050B)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-454-014 g in 1 CARTON; Type 0: Not a Combination Product06/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/15/2021
    ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 NUDE TRANSLUCIDE 
    octinoxate, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-452
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BRAZILIAN PEPPER (UNII: SUG822G7CD)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    CERAMIDE NP (UNII: 4370DF050B)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-452-014 g in 1 CARTON; Type 0: Not a Combination Product06/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/15/2021
    ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 CERISE BRISE 
    octinoxate, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-456
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    BRAZILIAN PEPPER (UNII: SUG822G7CD)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    CERAMIDE NP (UNII: 4370DF050B)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-456-014 g in 1 CARTON; Type 0: Not a Combination Product06/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/15/2021
    Labeler - BEL STAR S A (880160197)
    Establishment
    NameAddressID/FEIBusiness Operations
    BEL STAR S A880160197manufacture(14141-452, 14141-453, 14141-454, 14141-455, 14141-456)
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