Label: 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
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Contains inactivated NDC Code(s)
NDC Code(s): 43596-0745-1, 43596-0746-1, 43596-0747-1, 43596-0748-1, view more43596-0749-1, 43596-0750-1 - Packager: Ventura Corporation LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 27, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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
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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
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ULTRA BALM MOISTURIZING PROTECTIVE LIPS SPF 20 NUDE TRANSLUCIDE
octinoxate, zinc oxide stickProduct 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 stickProduct 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 stickProduct 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 stickProduct 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 stickProduct 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 stickProduct 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)
