Label: LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 NUDE TRANSLUCIDE - BEIGE- octinoxate and zinc oxide lipstick
LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 CORAL PETALE - PINK- octinoxate and zinc oxide lipstick
LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 ROSE PARADISE - PINK- octinoxate and zinc oxide lipstick
LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 ROSE COTTON - PINK- octinoxate and zinc oxide lipstick
LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 CERISE BRISE - PINK- octinoxate and zinc oxide lipstick
LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 NUDE CARAMEL - BEIGE- octinoxate and zinc oxide lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-508-01, 13537-508-02, 13537-509-01, 13537-509-02, view more13537-510-01, 13537-510-02, 13537-569-01, 13537-569-02, 13537-755-01, 13537-755-02, 13537-756-01, 13537-756-02 - 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 October 26, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
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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
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NUDE TRANSLUCIDE - BEIGE
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CORAL PETALE - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE PARADISE - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE COTTON - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CERISE BRISE - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NUDE CARAMEL - BEIGE
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INGREDIENTS AND APPEARANCE
LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 NUDE TRANSLUCIDE - BEIGE
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-755 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) CERESIN (UNII: Q1LS2UJO3A) 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) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BRAZILIAN PEPPER (UNII: SUG822G7CD) 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) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ALUMINUM OXIDE (UNII: LMI26O6933) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 6 (UNII: 481744AI4O) 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:13537-755-02 1 in 1 BOX 10/26/2016 1 NDC:13537-755-01 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 10/26/2016 LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 CORAL PETALE - PINK
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-756 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) CERESIN (UNII: Q1LS2UJO3A) 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) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BRAZILIAN PEPPER (UNII: SUG822G7CD) 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) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ALUMINUM OXIDE (UNII: LMI26O6933) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 6 (UNII: 481744AI4O) 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:13537-756-02 1 in 1 BOX 10/26/2016 1 NDC:13537-756-01 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 10/26/2016 LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 ROSE PARADISE - PINK
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-508 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) CERESIN (UNII: Q1LS2UJO3A) 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) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BRAZILIAN PEPPER (UNII: SUG822G7CD) 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) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ALUMINUM OXIDE (UNII: LMI26O6933) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 6 (UNII: 481744AI4O) 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:13537-508-02 1 in 1 BOX 10/26/2016 1 NDC:13537-508-01 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 10/26/2016 LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 ROSE COTTON - PINK
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-509 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) CERESIN (UNII: Q1LS2UJO3A) 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) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BRAZILIAN PEPPER (UNII: SUG822G7CD) 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) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ALUMINUM OXIDE (UNII: LMI26O6933) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 6 (UNII: 481744AI4O) 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:13537-509-02 1 in 1 BOX 10/26/2016 1 NDC:13537-509-01 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 10/26/2016 LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 CERISE BRISE - PINK
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-510 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) CERESIN (UNII: Q1LS2UJO3A) 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) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BRAZILIAN PEPPER (UNII: SUG822G7CD) 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) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ALUMINUM OXIDE (UNII: LMI26O6933) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 6 (UNII: 481744AI4O) 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:13537-510-02 1 in 1 BOX 10/26/2016 1 NDC:13537-510-01 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 10/26/2016 LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 NUDE CARAMEL - BEIGE
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-569 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) CERESIN (UNII: Q1LS2UJO3A) 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) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BRAZILIAN PEPPER (UNII: SUG822G7CD) 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) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ALUMINUM OXIDE (UNII: LMI26O6933) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 6 (UNII: 481744AI4O) 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:13537-569-02 1 in 1 BOX 10/26/2016 1 NDC:13537-569-01 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 10/26/2016 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-755, 13537-756, 13537-508, 13537-509, 13537-510, 13537-569)