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
Ventura International 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.

----------

L'BEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20

Drug Facts

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.

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 - Nude Translucent/ Beige

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 - Coral Petale/ Red

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 Paradise/ Red

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 - Rose Cotton/ Red

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 - Cerise Brise/ Red

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)

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	11/10/2018

Labeler - Ventura International LTD (603192787)

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

Revised: 11/2018

Document Id: e68475b3-704f-4a0b-ac04-d3e95e82f994

Set id: 7e951285-bd30-4cff-bd11-b7e0fa8bc1fc

Version: 1

Effective Time: 20181113

Ventura International LTD