ULTRA BALM MOISTURIZING PROTECTIVE LIPS SPF 20 NUDE TRANSLUCIDE- octinoxate, zinc oxide stick 
ULTRA BALM MOISTURIZING PROTECTIVE LIPS SPF 20 CORAL PETALE- octinoxate, zinc oxide stick 
ULTRA BALM MOISTURIZING PROTECTIVE LIPS SPF 20 ROSE PARADISE- octinoxate, zinc oxide stick 
ULTRA BALM MOISTURIZING PROTECTIVE LIPS SPF 20 ROSE COTTON- octinoxate, zinc oxide stick 
ULTRA BALM MOISTURIZING PROTECTIVE LIPS SPF 20 CERISE BRISE- octinoxate, zinc oxide stick 
ULTRA BALM MOISTURIZING PROTECTIVE LIPS SPF 20 NUDE CARAMEL- octinoxate, zinc oxide stick 
Ventura Corporation LTD

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.

----------

Ultra Balm Moisturizing Protective for Lips SPF 20


Active Ingredients Purpose

Octinoxate 7.50%................................................................. Sunscreen
Zinc oxide 4.90 %.......................................................... Sunscreen


Uses
Helps prevent sunburn.


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

Stop use and ask a doctor if rash occurs.


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.


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


Inactive ingredients: Octyldodecanol, ethylhexyl palmitate, polyethylene, ozokerite, mica, 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, schinus terebinthifolia seed extract, phenoxyethanol, dimethicone, acacia decurrens flower wax, polyglycerin-3, triethoxycaprylylsilane, caprylyl glycol, chlorphenesin, trimethylsiloxysilicate, ceramide np.
may contain:
mica, titanium dioxide, dipentaerythrityl hexacaprylate/hexacaprate, synthetic fluorphlogopite, tridecyl trimellitate, iron oxides, yellow 5 lake, red 7 lake, red 6 lake, tridecyl stearate, neopentyl glycol dicaprylate/dicaprate, talc.

L'Bel

Ultra Balm

Moisturizing Protective Balm for Lips SPF 20 Nude Translucide

Net Wt. 0.14 oz (4g)

Ultra Balm

L'Bel

Ultra Balm

Moisturizing Protective Balm for Lips SPF 20 Coral Petal

Net Wt. 0.14 oz (4g)

Coral Petal

L'Bel

Ultra Balm

Moisturizing Protective Balm for Lips SPF 20 Rose Paradise

Net Wt. 0.14 oz (4g)

Rose Paradise

L'Bel

Ultra Balm

Moisturizing Protective Balm for Lips SPF 20 Rose Cotton

Net Wt. 0.14 oz (4g)

Rose Cotton

L'Bel

Ultra Balm

Moisturizing Protective Balm for Lips SPF 20 Cerise Brise

Net Wt. 0.14 oz (4g)

Cerise Brise

L'Bel

Ultra Balm

Moisturizing Protective Balm for Lips SPF 20 Nude Caramel

Net Wt. 0.14 oz (4g)

Nude Caramel

ULTRA BALM MOISTURIZING PROTECTIVE LIPS SPF 20 NUDE TRANSLUCIDE 
octinoxate, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0745
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TRIDECYL STEARATE (UNII: A8OE252M6L)  
BRAZILIAN PEPPER (UNII: SUG822G7CD)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
CERAMIDE NP (UNII: 4370DF050B)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TALC (UNII: 7SEV7J4R1U)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MICA (UNII: V8A1AW0880)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CERESIN (UNII: Q1LS2UJO3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0745-14 g in 1 CARTON; Type 0: Not a Combination Product02/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/28/2020
ULTRA BALM MOISTURIZING PROTECTIVE LIPS SPF 20 CORAL PETALE 
octinoxate, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0746
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TRIDECYL STEARATE (UNII: A8OE252M6L)  
BRAZILIAN PEPPER (UNII: SUG822G7CD)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
CERAMIDE NP (UNII: 4370DF050B)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TALC (UNII: 7SEV7J4R1U)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MICA (UNII: V8A1AW0880)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CERESIN (UNII: Q1LS2UJO3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0746-14 g in 1 CARTON; Type 0: Not a Combination Product02/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/28/2020
ULTRA BALM MOISTURIZING PROTECTIVE LIPS SPF 20 ROSE PARADISE 
octinoxate, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0747
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TRIDECYL STEARATE (UNII: A8OE252M6L)  
BRAZILIAN PEPPER (UNII: SUG822G7CD)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
CERAMIDE NP (UNII: 4370DF050B)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TALC (UNII: 7SEV7J4R1U)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MICA (UNII: V8A1AW0880)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CERESIN (UNII: Q1LS2UJO3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0747-14 g in 1 CARTON; Type 0: Not a Combination Product02/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/28/2020
ULTRA BALM MOISTURIZING PROTECTIVE LIPS SPF 20 ROSE COTTON 
octinoxate, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0748
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TRIDECYL STEARATE (UNII: A8OE252M6L)  
BRAZILIAN PEPPER (UNII: SUG822G7CD)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
CERAMIDE NP (UNII: 4370DF050B)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TALC (UNII: 7SEV7J4R1U)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MICA (UNII: V8A1AW0880)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CERESIN (UNII: Q1LS2UJO3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0748-14 g in 1 CARTON; Type 0: Not a Combination Product02/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/28/2020
ULTRA BALM MOISTURIZING PROTECTIVE LIPS SPF 20 CERISE BRISE 
octinoxate, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0749
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TRIDECYL STEARATE (UNII: A8OE252M6L)  
BRAZILIAN PEPPER (UNII: SUG822G7CD)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
CERAMIDE NP (UNII: 4370DF050B)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TALC (UNII: 7SEV7J4R1U)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MICA (UNII: V8A1AW0880)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CERESIN (UNII: Q1LS2UJO3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0749-14 g in 1 CARTON; Type 0: Not a Combination Product02/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/28/2020
ULTRA BALM MOISTURIZING PROTECTIVE LIPS SPF 20 NUDE CARAMEL 
octinoxate, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0750
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TRIDECYL STEARATE (UNII: A8OE252M6L)  
BRAZILIAN PEPPER (UNII: SUG822G7CD)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
CERAMIDE NP (UNII: 4370DF050B)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TALC (UNII: 7SEV7J4R1U)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MICA (UNII: V8A1AW0880)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CERESIN (UNII: Q1LS2UJO3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0750-14 g in 1 CARTON; Type 0: Not a Combination Product02/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/28/2020
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
BEL STAR S A880160197manufacture(43596-0745, 43596-0746, 43596-0747, 43596-0748, 43596-0749, 43596-0750)

Revised: 2/2020
Document Id: 9f970484-bc3e-4f08-e053-2995a90a8844
Set id: 9f970484-bc3d-4f08-e053-2995a90a8844
Version: 1
Effective Time: 20200227
 
Ventura Corporation LTD