DailyMed - 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

Contains inactivated NDC Code(s)
NDC Code(s): 14783-866-01, 14783-866-02, 14783-867-01, 14783-867-02, view more
14783-868-01, 14783-868-02, 14783-869-01, 14783-869-02, 14783-941-01, 14783-941-02, 14783-942-01, 14783-942-02, 14783-943-01, 14783-943-02, 14783-944-01, 14783-944-02
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 January 15, 2016

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

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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

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/22/2015

Labeler - Ventura International LTD (603192787)

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

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	NDC
1	14783-866-01
2	14783-866-02 (inactivated)
3	14783-867-01
4	14783-867-02 (inactivated)
5	14783-868-01
6	14783-868-02 (inactivated)
7	14783-869-01
8	14783-869-02 (inactivated)
9	14783-941-01
10	14783-941-02 (inactivated)
11	14783-942-01
12	14783-942-02 (inactivated)
13	14783-943-01
14	14783-943-02 (inactivated)
15	14783-944-01
16	14783-944-02 (inactivated)

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If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.