ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 CORAL PETALE- octinoxate, zinc oxide stick ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 ROSE PARADISE- octinoxate, zinc oxide stick ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 ROSE COTTON- octinoxate, zinc oxide stick ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 NUDE TRANSLUCIDE- octinoxate, zinc oxide stick ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 CERISE BRISE- octinoxate, zinc oxide stick
Ultra Balm Moisturizing Protective Balm for lips SPF 20 Cerise Brise by
Drug Labeling and Warnings
Ultra Balm Moisturizing Protective Balm for lips SPF 20 Cerise Brise 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
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
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
-
INACTIVE INGREDIENT
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. - OTHER SAFETY INFORMATION
- 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
-
INGREDIENTS AND APPEARANCE
ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 CORAL PETALE
octinoxate, zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 43596-0886 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 43596-0886-1 4 g in 1 CARTON; Type 0: Not a Combination Product 06/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/15/2021 ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 ROSE PARADISE
octinoxate, zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 43596-0888 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 43596-0888-1 4 g in 1 CARTON; Type 0: Not a Combination Product 06/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/15/2021 ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 ROSE COTTON
octinoxate, zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 43596-0887 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 43596-0887-1 4 g in 1 CARTON; Type 0: Not a Combination Product 06/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/15/2021 ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 NUDE TRANSLUCIDE
octinoxate, zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 43596-0885 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 43596-0885-1 4 g in 1 CARTON; Type 0: Not a Combination Product 06/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/15/2021 ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 CERISE BRISE
octinoxate, zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 43596-0889 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 43596-0889-1 4 g in 1 CARTON; Type 0: Not a Combination Product 06/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/15/2021 Labeler - Ventura Corporation LTD (602751344) Registrant - BEL STAR S A (880160197) Establishment Name Address ID/FEI Business Operations BEL STAR S A 880160197 manufacture(43596-0885, 43596-0886, 43596-0887, 43596-0888, 43596-0889)
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