Label: LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM PECHE - BROWN- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM SWEET FRAMBOISE - PINK- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM DOUCE - PINK- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM VIN - BROWN- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM GRAPE LUMIERE - PINK- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM CARAMEL MELON - BROWN- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM GROSEILLE - BROWN- octinoxate and oxybenzone lipstick
LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM VIN SENSUELLE - RED- octinoxate and oxybenzone lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-704-01, 13537-704-02, 13537-705-01, 13537-705-02, view more13537-706-01, 13537-706-02, 13537-707-01, 13537-707-02, 13537-708-01, 13537-708-02, 13537-709-01, 13537-709-02, 13537-710-01, 13537-710-02, 13537-711-01, 13537-711-02 - 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 January 14, 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
HYDROGENATED POLYISOBUTENE, DIISOPROPYL DIMER DILINOLEATE, ISOSTEARYL NEOPENTANOATE, SYNTHETIC BEESWAX, SILICA DIMETHYL SILYLATE, PARFUM (FRAGRANCE), PHENOXYETHANOL, GLYCERIN, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL), TOCOPHERYL ACETATE, COCOS NUCIFERA (COCONUT) OIL, ALOE BARBADENSIS LEAF EXTRACT, HYDROGENATED VEGETABLE OIL, SODIUM SACCHARIN, CAPRYLYL GLYCOL, CHLORPHENESIN, BHT, CITRUS LIMON (LEMON) PEEL WAX, CITRUS LIMON (LEMON) PEEL OIL, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, CITRUS AURANTIUM DULCIS (ORANGE) PEEL WAX, d-LIMONENE, BENZYL ALCOHOL, BENZYL SALICYLATE, HEXYL CINNAMAL, METHYL 2-OCTYNOATE, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, CINNAMAL.
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 - 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 - GRAPE LUMIERE - PINK
- 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 LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM PECHE - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-704 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) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERIN (UNII: PDC6A3C0OX) ALMOND OIL (UNII: 66YXD4DKO9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) LEMON PEEL WAX (UNII: 20G0UPO0TI) LEMON OIL (UNII: I9GRO824LL) ORANGE OIL (UNII: AKN3KSD11B) ORANGE PEEL WAX (UNII: 0U715N387C) LIMONENE, (+)- (UNII: GFD7C86Q1W) BENZYL ALCOHOL (UNII: LKG8494WBH) BENZYL SALICYLATE (UNII: WAO5MNK9TU) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3) HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) CINNAMALDEHYDE (UNII: SR60A3XG0F) 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:13537-704-02 1 in 1 BOX 1 NDC:13537-704-01 12 mL 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 12/22/2015 LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM SWEET FRAMBOISE - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-705 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) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERIN (UNII: PDC6A3C0OX) ALMOND OIL (UNII: 66YXD4DKO9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) LEMON PEEL WAX (UNII: 20G0UPO0TI) LEMON OIL (UNII: I9GRO824LL) ORANGE OIL (UNII: AKN3KSD11B) ORANGE PEEL WAX (UNII: 0U715N387C) LIMONENE, (+)- (UNII: GFD7C86Q1W) BENZYL ALCOHOL (UNII: LKG8494WBH) BENZYL SALICYLATE (UNII: WAO5MNK9TU) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3) HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) CINNAMALDEHYDE (UNII: SR60A3XG0F) 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:13537-705-02 1 in 1 BOX 1 NDC:13537-705-01 12 mL 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 12/22/2015 LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM DOUCE - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-706 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) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERIN (UNII: PDC6A3C0OX) ALMOND OIL (UNII: 66YXD4DKO9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) LEMON PEEL WAX (UNII: 20G0UPO0TI) LEMON OIL (UNII: I9GRO824LL) ORANGE OIL (UNII: AKN3KSD11B) ORANGE PEEL WAX (UNII: 0U715N387C) LIMONENE, (+)- (UNII: GFD7C86Q1W) BENZYL ALCOHOL (UNII: LKG8494WBH) BENZYL SALICYLATE (UNII: WAO5MNK9TU) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3) HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) CINNAMALDEHYDE (UNII: SR60A3XG0F) 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:13537-706-02 1 in 1 BOX 1 NDC:13537-706-01 12 mL 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 12/22/2015 LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM VIN - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-707 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) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERIN (UNII: PDC6A3C0OX) ALMOND OIL (UNII: 66YXD4DKO9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) LEMON PEEL WAX (UNII: 20G0UPO0TI) LEMON OIL (UNII: I9GRO824LL) ORANGE OIL (UNII: AKN3KSD11B) ORANGE PEEL WAX (UNII: 0U715N387C) LIMONENE, (+)- (UNII: GFD7C86Q1W) BENZYL ALCOHOL (UNII: LKG8494WBH) BENZYL SALICYLATE (UNII: WAO5MNK9TU) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3) HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) CINNAMALDEHYDE (UNII: SR60A3XG0F) 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:13537-707-02 1 in 1 BOX 1 NDC:13537-707-01 12 mL 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 12/22/2015 LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM GRAPE LUMIERE - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-708 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) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERIN (UNII: PDC6A3C0OX) ALMOND OIL (UNII: 66YXD4DKO9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) LEMON PEEL WAX (UNII: 20G0UPO0TI) LEMON OIL (UNII: I9GRO824LL) ORANGE OIL (UNII: AKN3KSD11B) ORANGE PEEL WAX (UNII: 0U715N387C) LIMONENE, (+)- (UNII: GFD7C86Q1W) BENZYL ALCOHOL (UNII: LKG8494WBH) BENZYL SALICYLATE (UNII: WAO5MNK9TU) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3) HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) CINNAMALDEHYDE (UNII: SR60A3XG0F) 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:13537-708-02 1 in 1 BOX 1 NDC:13537-708-01 12 mL 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 12/22/2015 LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM CARAMEL MELON - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-709 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) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERIN (UNII: PDC6A3C0OX) ALMOND OIL (UNII: 66YXD4DKO9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) LEMON PEEL WAX (UNII: 20G0UPO0TI) LEMON OIL (UNII: I9GRO824LL) ORANGE OIL (UNII: AKN3KSD11B) ORANGE PEEL WAX (UNII: 0U715N387C) LIMONENE, (+)- (UNII: GFD7C86Q1W) BENZYL ALCOHOL (UNII: LKG8494WBH) BENZYL SALICYLATE (UNII: WAO5MNK9TU) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3) HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) CINNAMALDEHYDE (UNII: SR60A3XG0F) 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:13537-709-02 1 in 1 BOX 1 NDC:13537-709-01 12 mL 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 12/22/2015 LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM GROSEILLE - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-710 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) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERIN (UNII: PDC6A3C0OX) ALMOND OIL (UNII: 66YXD4DKO9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) LEMON PEEL WAX (UNII: 20G0UPO0TI) LEMON OIL (UNII: I9GRO824LL) ORANGE OIL (UNII: AKN3KSD11B) ORANGE PEEL WAX (UNII: 0U715N387C) LIMONENE, (+)- (UNII: GFD7C86Q1W) BENZYL ALCOHOL (UNII: LKG8494WBH) BENZYL SALICYLATE (UNII: WAO5MNK9TU) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3) HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) CINNAMALDEHYDE (UNII: SR60A3XG0F) 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:13537-710-02 1 in 1 BOX 1 NDC:13537-710-01 12 mL 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 12/22/2015 LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM VIN SENSUELLE - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-711 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) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERIN (UNII: PDC6A3C0OX) ALMOND OIL (UNII: 66YXD4DKO9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) LEMON PEEL WAX (UNII: 20G0UPO0TI) LEMON OIL (UNII: I9GRO824LL) ORANGE OIL (UNII: AKN3KSD11B) ORANGE PEEL WAX (UNII: 0U715N387C) LIMONENE, (+)- (UNII: GFD7C86Q1W) BENZYL ALCOHOL (UNII: LKG8494WBH) BENZYL SALICYLATE (UNII: WAO5MNK9TU) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3) HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) CINNAMALDEHYDE (UNII: SR60A3XG0F) 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:13537-711-02 1 in 1 BOX 1 NDC:13537-711-01 12 mL 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 12/22/2015 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-704, 13537-705, 13537-706, 13537-707, 13537-708, 13537-709, 13537-710, 13537-711)