Label: 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
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-152-01, 14783-152-02, 14783-153-01, 14783-153-02, view more14783-154-01, 14783-154-02, 14783-155-01, 14783-155-02, 14783-156-01, 14783-156-02, 14783-157-01, 14783-157-02 - Packager: Ventura International 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 November 13, 2018
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 Carton - Nude Translucent/ Beige
- PRINCIPAL DISPLAY PANEL - 4 g Tube Carton - Coral Petale/ Red
- PRINCIPAL DISPLAY PANEL - 4 g Tube Carton - Rose Paradise/ Red
- PRINCIPAL DISPLAY PANEL - 4 g Tube Carton - Rose Cotton/ Red
- PRINCIPAL DISPLAY PANEL - 4 g Tube Carton - Cerise Brise/ Red
- PRINCIPAL DISPLAY PANEL - 4 g Tube Carton - Nude Caramel/ Beige
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INGREDIENTS AND APPEARANCE
LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 NUDE TRANSLUCENT/BEIGE
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-152 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) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/10/2018 LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 CORAL PETALE/ RED
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-153 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) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/10/2018 LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 ROSE PARADISE/ RED
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-154 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) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/10/2018 LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 ROSE COTTON/ RED
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-155 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) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/10/2018 LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 CERISE BRISE / RED
octinoxate and zinc oxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-156 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) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/10/2018 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:14783-157 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) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/10/2018 Labeler - Ventura International LTD (603192787) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(14783-152, 14783-153, 14783-154, 14783-155, 14783-156, 14783-157)