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

LBEL DIVINE LIP GLOSS Lip gloss SPF 15 FM Brillo labial FPS 15 FM by

Drug Labeling and Warnings

LBEL DIVINE LIP GLOSS Lip gloss SPF 15 FM Brillo labial FPS 15 FM by is a Otc medication manufactured, distributed, or labeled by Ventura International LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
OCTINOXATE 7.50 %,	Sunscreen
OXYBENZONE 3.00 %	Sunscreen

Uses

• Helps prevent sunburn.

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.

• Stop use and ask a doctor if rash occurs.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months of age: Ask a doctor

Other information

• Protect the product in this container from excessive heat and direct sun.

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

Dist. by Ventura Int Ltd. DBA Belcorp USA, Miami, FL 33126.

PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - PECHE - BROWN

DIVINE LIP GLOSS
Lip gloss SPF 15 FM

12 ml e (0.40 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - SWEET FRAMBOISE - PINK

DIVINE LIP GLOSS
Lip gloss SPF 15 FM

12 ml e (0.40 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - DOUCE - PINK

DIVINE LIP GLOSS
Lip gloss SPF 15 FM

12 ml e (0.40 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - VIN - BROWN

DIVINE LIP GLOSS
Lip gloss SPF 15 FM

12 ml e (0.40 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - GRAPE LUMIERE - PINK

DIVINE LIP GLOSS
Lip gloss SPF 15 FM

12 ml e (0.40 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - CARAMEL MELON - BROWN

DIVINE LIP GLOSS
Lip gloss SPF 15 FM

12 ml e (0.40 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - GROSEILLE - BROWN

DIVINE LIP GLOSS
Lip gloss SPF 15 FM

12 ml e (0.40 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 12 ml Tube Box - VIN SENSUELLE - RED

DIVINE LIP GLOSS
Lip gloss SPF 15 FM

12 ml e (0.40 fl.oz.)

L'BEL

INGREDIENTS AND APPEARANCE

LBEL DIVINE LIP GLOSS LIP GLOSS SPF 15 FM BRILLO LABIAL FPS 15 FM   PECHE - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-866
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: 14783-866-02	1 in 1 BOX
1	NDC: 14783-866-01	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 lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-867
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: 14783-867-02	1 in 1 BOX
1	NDC: 14783-867-01	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 lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-868
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: 14783-868-02	1 in 1 BOX
1	NDC: 14783-868-01	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 lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-869
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: 14783-869-02	1 in 1 BOX
1	NDC: 14783-869-01	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 lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-941
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: 14783-941-02	1 in 1 BOX
1	NDC: 14783-941-01	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 lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-942
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: 14783-942-02	1 in 1 BOX
1	NDC: 14783-942-01	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 lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-943
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: 14783-943-02	1 in 1 BOX
1	NDC: 14783-943-01	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 lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-944
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: 14783-944-02	1 in 1 BOX
1	NDC: 14783-944-01	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 International LTD (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-866, 14783-867, 14783-868, 14783-869, 14783-941, 14783-942, 14783-943, 14783-944)