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

Ultra Balm Moisturizing Protective lips SPF 20 Nude Caramel by

Drug Labeling and Warnings

Ultra Balm Moisturizing Protective lips SPF 20 Nude Caramel by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD, BEL STAR S A. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

L'Bel

Ultra Balm

Moisturizing Protective Balm for Lips SPF 20 Nude Translucide

Net Wt. 0.14 oz (4g)

PRINCIPAL DISPLAY PANEL

L'Bel

Ultra Balm

Moisturizing Protective Balm for Lips SPF 20 Coral Petal

Net Wt. 0.14 oz (4g)

PRINCIPAL DISPLAY PANEL

L'Bel

Ultra Balm

Moisturizing Protective Balm for Lips SPF 20 Rose Paradise

Net Wt. 0.14 oz (4g)

PRINCIPAL DISPLAY PANEL

L'Bel

Ultra Balm

Moisturizing Protective Balm for Lips SPF 20 Rose Cotton

Net Wt. 0.14 oz (4g)

PRINCIPAL DISPLAY PANEL

L'Bel

Ultra Balm

Moisturizing Protective Balm for Lips SPF 20 Cerise Brise

Net Wt. 0.14 oz (4g)

PRINCIPAL DISPLAY PANEL

L'Bel

Ultra Balm

Moisturizing Protective Balm for Lips SPF 20 Nude Caramel

Net Wt. 0.14 oz (4g)

INGREDIENTS AND APPEARANCE

ULTRA BALM MOISTURIZING PROTECTIVE LIPS SPF 20 NUDE TRANSLUCIDE 
octinoxate, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0745
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0745-1	4 g in 1 CARTON; Type 0: Not a Combination Product	02/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/28/2020

ULTRA BALM MOISTURIZING PROTECTIVE LIPS SPF 20 CORAL PETALE 
octinoxate, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0746
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0746-1	4 g in 1 CARTON; Type 0: Not a Combination Product	02/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/28/2020

ULTRA BALM MOISTURIZING PROTECTIVE LIPS SPF 20 ROSE PARADISE 
octinoxate, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0747
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0747-1	4 g in 1 CARTON; Type 0: Not a Combination Product	02/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/28/2020

ULTRA BALM MOISTURIZING PROTECTIVE LIPS SPF 20 ROSE COTTON 
octinoxate, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0748
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0748-1	4 g in 1 CARTON; Type 0: Not a Combination Product	02/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/28/2020

ULTRA BALM MOISTURIZING PROTECTIVE LIPS SPF 20 CERISE BRISE 
octinoxate, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0749
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0749-1	4 g in 1 CARTON; Type 0: Not a Combination Product	02/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/28/2020

ULTRA BALM MOISTURIZING PROTECTIVE LIPS SPF 20 NUDE CARAMEL 
octinoxate, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0750
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0750-1	4 g in 1 CARTON; Type 0: Not a Combination Product	02/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/28/2020

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
BEL STAR S A		880160197	manufacture(43596-0745, 43596-0746, 43596-0747, 43596-0748, 43596-0749, 43596-0750)