LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 NUDE TRANSLUCENT/BEIGE- octinoxate and zinc oxide lipstick LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 CORAL PETALE/ RED- octinoxate and zinc oxide lipstick LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 ROSE PARADISE/ RED- octinoxate and zinc oxide lipstick LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 ROSE COTTON/ RED- octinoxate and zinc oxide lipstick LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 CERISE BRISE / RED- octinoxate and zinc oxide lipstick LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 NUDE CARAMEL/ BEIGE- octinoxate and zinc oxide lipstick

LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 by

Drug Labeling and Warnings

LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 by is a Otc medication manufactured, distributed, or labeled by Ventura International LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
OCTINOXATE 7.5 %	Sunscreen
ZINC OXIDE 4.9 %	Sunscreen

Uses

• Helps prevent sunburn.

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.

• Stop use and ask a doctor if rash occurs.

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

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 information

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

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 TEREBINTHIFOLIUS SEED EXTRACT, PHENOXYETHANOL, DIMETHICONE, ACACIA DECURRENS FLOWER WAX, POLYGLYCERIN-3, TRIETHOXYCAPRYLYLSILANE, CAPRYLYL GLYCOL, CHLORPHENESIN, TRIMETHYLSILOXYSILICATE, CERAMIDE 3. MAY CONTAIN: MICA, TITANIUM DIOXIDE, DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, TRIDECYL TRIMELLITATE, IRON OXIDES, YELLOW 5 LAKE, RED 7 LAKE, RED 6 LAKE, TRIDECYL STEARATE, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, TALC.

SPL UNCLASSIFIED SECTION

Dist. by Ventura Int Ltd.
DBA Belcorp USA, Miami, FL 33126

PRINCIPAL DISPLAY PANEL - 4 g Tube Carton - Nude Translucent/ Beige

L'BEL
ULTRA
BALM

Moisturizing protective
balm for lips
SPF 20

Net Wt. 0.14 oz e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Carton - Coral Petale/ Red

L'BEL
ULTRA
BALM

Moisturizing protective
balm for lips
SPF 20

Net Wt. 0.14 oz e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Carton - Rose Paradise/ Red

L'BEL
ULTRA
BALM

Moisturizing protective
balm for lips
SPF 20

Net Wt. 0.14 oz e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Carton - Rose Cotton/ Red

L'BEL
ULTRA
BALM

Moisturizing protective
balm for lips
SPF 20

Net Wt. 0.14 oz e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Carton - Cerise Brise/ Red

L'BEL
ULTRA
BALM

Moisturizing protective
balm for lips
SPF 20

Net Wt. 0.14 oz e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Carton - Nude Caramel/ Beige

L'BEL
ULTRA
BALM

Moisturizing protective
balm for lips
SPF 20

Net Wt. 0.14 oz e (4 g)

INGREDIENTS AND APPEARANCE

LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20  NUDE TRANSLUCENT/BEIGE
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-152
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-152-02	1 in 1 CARTON	11/10/2018
1	NDC: 14783-152-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/10/2018

LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20  CORAL PETALE/ RED
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-153
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-153-02	1 in 1 CARTON	11/10/2018
1	NDC: 14783-153-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/10/2018

LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20  ROSE PARADISE/ RED
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-154
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-154-02	1 in 1 CARTON	11/10/2018
1	NDC: 14783-154-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/10/2018

LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20  ROSE COTTON/ RED
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-155
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-155-02	1 in 1 CARTON	11/10/2018
1	NDC: 14783-155-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/10/2018

LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20  CERISE BRISE / RED
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-156
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-156-02	1 in 1 CARTON	11/10/2018
1	NDC: 14783-156-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/10/2018

LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20  NUDE CARAMEL/ BEIGE
octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-157
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-157-02	1 in 1 CARTON	11/10/2018
1	NDC: 14783-157-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/10/2018

Labeler - Ventura International LTD (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-152, 14783-153, 14783-154, 14783-155, 14783-156, 14783-157)