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

Other Information

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

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

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-453
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-453-01	4 g in 1 CARTON; Type 0: Not a Combination Product	06/15/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/15/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-455
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-455-01	4 g in 1 CARTON; Type 0: Not a Combination Product	06/15/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/15/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-454
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-454-01	4 g in 1 CARTON; Type 0: Not a Combination Product	06/15/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/15/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-452
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-452-01	4 g in 1 CARTON; Type 0: Not a Combination Product	06/15/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/15/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-456
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-456-01	4 g in 1 CARTON; Type 0: Not a Combination Product	06/15/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/15/2021

Labeler - BEL STAR S A (880160197)

Name	Address	ID/FEI	Business Operations
Establishment
BEL STAR S A		880160197	manufacture(14141-452, 14141-453, 14141-454, 14141-455, 14141-456)

Ultra Balm Moisturizing Protective Balm for Lips SPF 20

Ultra Balm SPF 20 Nude Translucide

Ultra Balm SPF 20 Coral Petal

Ultra Balm SPF 20 Rose Paradise

Ultra Balm SPF 20 Rose Cotton

Ultra Balm SPF 20 Cerise Brise