Label: LBEL DIVINE LIP GLOSS SPF 15 (PECHE) - BROWN- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS SPF 15 (GRAPE LUMIERE) - MAGENTA- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS SPF 15 (SWEET FRAMBOISE) - PINK- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS SPF 15 (DOUCE) - PINK- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS SPF 15 (VIN) - BROWN- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS SPF 15 (CARAMEL MELON) - BROWN- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS SPF 15 (GROSEILLE) - BROWN- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS SPF 15 (VIN SENSUELLE) - RED- octinoxate and oxybenzone lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-467-01, 14783-467-02, 14783-468-03, 14783-468-04, view more14783-469-05, 14783-469-06, 14783-470-07, 14783-470-08, 14783-471-09, 14783-471-10, 14783-472-11, 14783-472-12, 14783-473-13, 14783-473-14, 14783-474-15, 14783-474-16 - 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 January 29, 2014
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
Hydrogenated polyisobutene, diisopropyl dimer dilinoleate, isostearyl neopentanoate, beeswax, silica dimethyl silylate, fragrance, glycerin, prunus amygdalus dulcis (sweet almond) oil, tocopheryl acetate, cocos nucifera (coconut) oil, aloe barbadensis leaf extract, hydrogenated vegetable oil, propylparaben, methylparaben, sodium saccharin, bht, citrus limon (lemon) peel wax, citrus limon (lemon) peel oil, citrus aurantium dulcis (orange) peel oil, citrus aurantium dulcis (orange) peel wax.
May contain: mica , red 7 lake , titanium dioxide, iron oxides, yellow 5 lake , red 40 lake, blue 1 lake, carmine, talc, palmitic acid.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - (PECHE) - BROWN
- PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - (GRAPE LUMIERE) - MAGENTA
- PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - (SWEET FRAMBOISE) - PINK
- PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - (DOUCE) - PINK
- PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - (VIN) - BROWN
- PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - (CARAMEL MELON) - BROWN
- PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - (GROSEILLE) - BROWN
- PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - (VIN SENSUELLE) - RED
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INGREDIENTS AND APPEARANCE
LBEL DIVINE LIP GLOSS SPF 15 (PECHE) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-467 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 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.03 g in 1 mL Inactive Ingredients Ingredient Name Strength diisopropyl dilinoleate (UNII: 5323S7S2LR) isostearyl neopentanoate (UNII: 411THY156Q) yellow wax (UNII: 2ZA36H0S2V) silica dimethyl silylate (UNII: EU2PSP0G0W) glycerin (UNII: PDC6A3C0OX) almond oil (UNII: 66YXD4DKO9) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) coconut oil (UNII: Q9L0O73W7L) aloe vera leaf (UNII: ZY81Z83H0X) propylparaben (UNII: Z8IX2SC1OH) methylparaben (UNII: A2I8C7HI9T) saccharin sodium (UNII: SB8ZUX40TY) butylated hydroxytoluene (UNII: 1P9D0Z171K) lemon peel wax (UNII: 20G0UPO0TI) lemon oil (UNII: I9GRO824LL) orange oil (UNII: AKN3KSD11B) orange peel wax (UNII: 0U715N387C) mica (UNII: V8A1AW0880) d&c red no. 7 (UNII: ECW0LZ41X8) aluminum oxide (UNII: LMI26O6933) titanium dioxide (UNII: 15FIX9V2JP) ferric oxide red (UNII: 1K09F3G675) fd&c yellow no. 5 (UNII: I753WB2F1M) fd&c red no. 40 (UNII: WZB9127XOA) fd&c blue no. 1 (UNII: H3R47K3TBD) talc (UNII: 7SEV7J4R1U) palmitic acid (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-467-02 1 in 1 BOX 1 NDC:14783-467-01 12 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 LBEL DIVINE LIP GLOSS SPF 15 (GRAPE LUMIERE) - MAGENTA
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-468 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 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.03 g in 1 mL Inactive Ingredients Ingredient Name Strength diisopropyl dilinoleate (UNII: 5323S7S2LR) isostearyl neopentanoate (UNII: 411THY156Q) yellow wax (UNII: 2ZA36H0S2V) silica dimethyl silylate (UNII: EU2PSP0G0W) glycerin (UNII: PDC6A3C0OX) almond oil (UNII: 66YXD4DKO9) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) coconut oil (UNII: Q9L0O73W7L) aloe vera leaf (UNII: ZY81Z83H0X) propylparaben (UNII: Z8IX2SC1OH) methylparaben (UNII: A2I8C7HI9T) saccharin sodium (UNII: SB8ZUX40TY) butylated hydroxytoluene (UNII: 1P9D0Z171K) lemon peel wax (UNII: 20G0UPO0TI) lemon oil (UNII: I9GRO824LL) orange oil (UNII: AKN3KSD11B) orange peel wax (UNII: 0U715N387C) mica (UNII: V8A1AW0880) d&c red no. 7 (UNII: ECW0LZ41X8) aluminum oxide (UNII: LMI26O6933) titanium dioxide (UNII: 15FIX9V2JP) ferric oxide red (UNII: 1K09F3G675) fd&c yellow no. 5 (UNII: I753WB2F1M) fd&c red no. 40 (UNII: WZB9127XOA) fd&c blue no. 1 (UNII: H3R47K3TBD) talc (UNII: 7SEV7J4R1U) palmitic acid (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-468-04 1 in 1 BOX 1 NDC:14783-468-03 12 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 LBEL DIVINE LIP GLOSS SPF 15 (SWEET FRAMBOISE) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-469 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 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.03 g in 1 mL Inactive Ingredients Ingredient Name Strength diisopropyl dilinoleate (UNII: 5323S7S2LR) isostearyl neopentanoate (UNII: 411THY156Q) yellow wax (UNII: 2ZA36H0S2V) silica dimethyl silylate (UNII: EU2PSP0G0W) glycerin (UNII: PDC6A3C0OX) almond oil (UNII: 66YXD4DKO9) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) coconut oil (UNII: Q9L0O73W7L) aloe vera leaf (UNII: ZY81Z83H0X) propylparaben (UNII: Z8IX2SC1OH) methylparaben (UNII: A2I8C7HI9T) saccharin sodium (UNII: SB8ZUX40TY) butylated hydroxytoluene (UNII: 1P9D0Z171K) lemon peel wax (UNII: 20G0UPO0TI) lemon oil (UNII: I9GRO824LL) orange oil (UNII: AKN3KSD11B) orange peel wax (UNII: 0U715N387C) mica (UNII: V8A1AW0880) d&c red no. 7 (UNII: ECW0LZ41X8) aluminum oxide (UNII: LMI26O6933) titanium dioxide (UNII: 15FIX9V2JP) ferric oxide red (UNII: 1K09F3G675) fd&c yellow no. 5 (UNII: I753WB2F1M) fd&c red no. 40 (UNII: WZB9127XOA) fd&c blue no. 1 (UNII: H3R47K3TBD) talc (UNII: 7SEV7J4R1U) palmitic acid (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-469-06 1 in 1 BOX 1 NDC:14783-469-05 12 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 LBEL DIVINE LIP GLOSS SPF 15 (DOUCE) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-470 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 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.03 g in 1 mL Inactive Ingredients Ingredient Name Strength diisopropyl dilinoleate (UNII: 5323S7S2LR) isostearyl neopentanoate (UNII: 411THY156Q) yellow wax (UNII: 2ZA36H0S2V) silica dimethyl silylate (UNII: EU2PSP0G0W) glycerin (UNII: PDC6A3C0OX) almond oil (UNII: 66YXD4DKO9) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) coconut oil (UNII: Q9L0O73W7L) aloe vera leaf (UNII: ZY81Z83H0X) propylparaben (UNII: Z8IX2SC1OH) methylparaben (UNII: A2I8C7HI9T) saccharin sodium (UNII: SB8ZUX40TY) butylated hydroxytoluene (UNII: 1P9D0Z171K) lemon peel wax (UNII: 20G0UPO0TI) lemon oil (UNII: I9GRO824LL) orange oil (UNII: AKN3KSD11B) orange peel wax (UNII: 0U715N387C) mica (UNII: V8A1AW0880) d&c red no. 7 (UNII: ECW0LZ41X8) aluminum oxide (UNII: LMI26O6933) titanium dioxide (UNII: 15FIX9V2JP) ferric oxide red (UNII: 1K09F3G675) fd&c yellow no. 5 (UNII: I753WB2F1M) fd&c red no. 40 (UNII: WZB9127XOA) fd&c blue no. 1 (UNII: H3R47K3TBD) talc (UNII: 7SEV7J4R1U) palmitic acid (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-470-08 1 in 1 BOX 1 NDC:14783-470-07 12 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 LBEL DIVINE LIP GLOSS SPF 15 (VIN) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-471 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 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.03 g in 1 mL Inactive Ingredients Ingredient Name Strength diisopropyl dilinoleate (UNII: 5323S7S2LR) isostearyl neopentanoate (UNII: 411THY156Q) yellow wax (UNII: 2ZA36H0S2V) silica dimethyl silylate (UNII: EU2PSP0G0W) glycerin (UNII: PDC6A3C0OX) almond oil (UNII: 66YXD4DKO9) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) coconut oil (UNII: Q9L0O73W7L) aloe vera leaf (UNII: ZY81Z83H0X) propylparaben (UNII: Z8IX2SC1OH) methylparaben (UNII: A2I8C7HI9T) saccharin sodium (UNII: SB8ZUX40TY) butylated hydroxytoluene (UNII: 1P9D0Z171K) lemon peel wax (UNII: 20G0UPO0TI) lemon oil (UNII: I9GRO824LL) orange oil (UNII: AKN3KSD11B) orange peel wax (UNII: 0U715N387C) mica (UNII: V8A1AW0880) d&c red no. 7 (UNII: ECW0LZ41X8) aluminum oxide (UNII: LMI26O6933) titanium dioxide (UNII: 15FIX9V2JP) ferric oxide red (UNII: 1K09F3G675) fd&c yellow no. 5 (UNII: I753WB2F1M) fd&c red no. 40 (UNII: WZB9127XOA) fd&c blue no. 1 (UNII: H3R47K3TBD) talc (UNII: 7SEV7J4R1U) palmitic acid (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-471-10 1 in 1 BOX 1 NDC:14783-471-09 12 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 LBEL DIVINE LIP GLOSS SPF 15 (CARAMEL MELON) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-472 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 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.03 g in 1 mL Inactive Ingredients Ingredient Name Strength diisopropyl dilinoleate (UNII: 5323S7S2LR) isostearyl neopentanoate (UNII: 411THY156Q) yellow wax (UNII: 2ZA36H0S2V) silica dimethyl silylate (UNII: EU2PSP0G0W) glycerin (UNII: PDC6A3C0OX) almond oil (UNII: 66YXD4DKO9) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) coconut oil (UNII: Q9L0O73W7L) aloe vera leaf (UNII: ZY81Z83H0X) propylparaben (UNII: Z8IX2SC1OH) methylparaben (UNII: A2I8C7HI9T) saccharin sodium (UNII: SB8ZUX40TY) butylated hydroxytoluene (UNII: 1P9D0Z171K) lemon peel wax (UNII: 20G0UPO0TI) lemon oil (UNII: I9GRO824LL) orange oil (UNII: AKN3KSD11B) orange peel wax (UNII: 0U715N387C) mica (UNII: V8A1AW0880) d&c red no. 7 (UNII: ECW0LZ41X8) aluminum oxide (UNII: LMI26O6933) titanium dioxide (UNII: 15FIX9V2JP) ferric oxide red (UNII: 1K09F3G675) fd&c yellow no. 5 (UNII: I753WB2F1M) fd&c red no. 40 (UNII: WZB9127XOA) fd&c blue no. 1 (UNII: H3R47K3TBD) talc (UNII: 7SEV7J4R1U) palmitic acid (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-472-12 1 in 1 BOX 1 NDC:14783-472-11 12 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 LBEL DIVINE LIP GLOSS SPF 15 (GROSEILLE) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-473 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 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.03 g in 1 mL Inactive Ingredients Ingredient Name Strength diisopropyl dilinoleate (UNII: 5323S7S2LR) isostearyl neopentanoate (UNII: 411THY156Q) yellow wax (UNII: 2ZA36H0S2V) silica dimethyl silylate (UNII: EU2PSP0G0W) glycerin (UNII: PDC6A3C0OX) almond oil (UNII: 66YXD4DKO9) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) coconut oil (UNII: Q9L0O73W7L) aloe vera leaf (UNII: ZY81Z83H0X) propylparaben (UNII: Z8IX2SC1OH) methylparaben (UNII: A2I8C7HI9T) saccharin sodium (UNII: SB8ZUX40TY) butylated hydroxytoluene (UNII: 1P9D0Z171K) lemon peel wax (UNII: 20G0UPO0TI) lemon oil (UNII: I9GRO824LL) orange oil (UNII: AKN3KSD11B) orange peel wax (UNII: 0U715N387C) mica (UNII: V8A1AW0880) d&c red no. 7 (UNII: ECW0LZ41X8) aluminum oxide (UNII: LMI26O6933) titanium dioxide (UNII: 15FIX9V2JP) ferric oxide red (UNII: 1K09F3G675) fd&c yellow no. 5 (UNII: I753WB2F1M) fd&c red no. 40 (UNII: WZB9127XOA) fd&c blue no. 1 (UNII: H3R47K3TBD) talc (UNII: 7SEV7J4R1U) palmitic acid (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-473-14 1 in 1 BOX 1 NDC:14783-473-13 12 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 LBEL DIVINE LIP GLOSS SPF 15 (VIN SENSUELLE) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-474 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 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.03 g in 1 mL Inactive Ingredients Ingredient Name Strength diisopropyl dilinoleate (UNII: 5323S7S2LR) isostearyl neopentanoate (UNII: 411THY156Q) yellow wax (UNII: 2ZA36H0S2V) silica dimethyl silylate (UNII: EU2PSP0G0W) glycerin (UNII: PDC6A3C0OX) almond oil (UNII: 66YXD4DKO9) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) coconut oil (UNII: Q9L0O73W7L) aloe vera leaf (UNII: ZY81Z83H0X) propylparaben (UNII: Z8IX2SC1OH) methylparaben (UNII: A2I8C7HI9T) saccharin sodium (UNII: SB8ZUX40TY) butylated hydroxytoluene (UNII: 1P9D0Z171K) lemon peel wax (UNII: 20G0UPO0TI) lemon oil (UNII: I9GRO824LL) orange oil (UNII: AKN3KSD11B) orange peel wax (UNII: 0U715N387C) mica (UNII: V8A1AW0880) d&c red no. 7 (UNII: ECW0LZ41X8) aluminum oxide (UNII: LMI26O6933) titanium dioxide (UNII: 15FIX9V2JP) ferric oxide red (UNII: 1K09F3G675) fd&c yellow no. 5 (UNII: I753WB2F1M) fd&c red no. 40 (UNII: WZB9127XOA) fd&c blue no. 1 (UNII: H3R47K3TBD) talc (UNII: 7SEV7J4R1U) palmitic acid (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-474-16 1 in 1 BOX 1 NDC:14783-474-15 12 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 Labeler - Ventura International LTD (603192787) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(14783-467, 14783-468, 14783-469, 14783-470, 14783-471, 14783-472, 14783-473, 14783-474)