DailyMed - 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)

Contains inactivated NDC Code(s)
NDC Code(s): 13537-467-01, 13537-467-02, 13537-468-03, 13537-468-04, view more
13537-469-05, 13537-469-06, 13537-470-07, 13537-470-08, 13537-471-09, 13537-471-10, 13537-472-11, 13537-472-12, 13537-473-13, 13537-473-14, 13537-474-15, 13537-474-16
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 29, 2014

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 7.5% Sunscreen

Oxybenzone 3% 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, 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

P.R.: Dist. by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.
PRINCIPAL DISPLAY PANEL - 12 ml Tube Carton - (PECHE) - BROWN

DIVINE LIP GLOSS
Lip gloss SPF 15

12 ml e (.40 fl.oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 12 ml Tube Carton - (GRAPE LUMIERE) - MAGENTA

DIVINE LIP GLOSS
Lip gloss SPF 15

12 ml e (.40 fl.oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 12 ml Tube Carton - (SWEET FRAMBOISE) - PINK

DIVINE LIP GLOSS
Lip gloss SPF 15

12 ml e (.40 fl.oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 12 ml Tube Carton - (DOUCE) - PINK

DIVINE LIP GLOSS
Lip gloss SPF 15

12 ml e (.40 fl.oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 12 ml Tube Carton - (VIN) - BROWN

DIVINE LIP GLOSS
Lip gloss SPF 15

12 ml e (.40 fl.oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 12 ml Tube Carton - (CARAMEL MELON) - BROWN

DIVINE LIP GLOSS
Lip gloss SPF 15

12 ml e (.40 fl.oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 12 ml Tube Carton - (GROSEILLE) - BROWN

DIVINE LIP GLOSS
Lip gloss SPF 15

12 ml e (.40 fl.oz.)
L'BEL
PRINCIPAL DISPLAY PANEL - 12 ml Tube Carton - (VIN SENSUELLE) - RED

DIVINE LIP GLOSS
Lip gloss SPF 15

12 ml e (.40 fl.oz.)
L'BEL

Active Ingredients	Purpose
Octinoxate 7.5%	Sunscreen
Oxybenzone 3%	Sunscreen

INGREDIENTS AND APPEARANCE

LBEL DIVINE LIP GLOSS SPF 15 (PECHE) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-467
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)
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-467-02	1 in 1 BOX
1	NDC:13537-467-01	12 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL DIVINE LIP GLOSS SPF 15 (GRAPE LUMIERE) - MAGENTA
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-468
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)
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-468-04	1 in 1 BOX
1	NDC:13537-468-03	12 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL DIVINE LIP GLOSS SPF 15 (SWEET FRAMBOISE) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-469
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)
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-469-06	1 in 1 BOX
1	NDC:13537-469-05	12 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL DIVINE LIP GLOSS SPF 15 (DOUCE) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-470
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)
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-470-08	1 in 1 BOX
1	NDC:13537-470-07	12 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL DIVINE LIP GLOSS SPF 15 (VIN) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-471
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)
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-471-10	1 in 1 BOX
1	NDC:13537-471-09	12 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL DIVINE LIP GLOSS SPF 15 (CARAMEL MELON) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-472
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)
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-472-12	1 in 1 BOX
1	NDC:13537-472-11	12 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL DIVINE LIP GLOSS SPF 15 (GROSEILLE) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-473
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)
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-473-14	1 in 1 BOX
1	NDC:13537-473-13	12 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/27/2014

LBEL DIVINE LIP GLOSS SPF 15 (VIN SENSUELLE) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-474
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)
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-474-16	1 in 1 BOX
1	NDC:13537-474-15	12 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/27/2014

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-467, 13537-468, 13537-469, 13537-470, 13537-471, 13537-472, 13537-473, 13537-474)

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	NDC
1	13537-467-01
2	13537-467-02 (inactivated)
3	13537-468-03
4	13537-468-04 (inactivated)
5	13537-469-05
6	13537-469-06 (inactivated)
7	13537-470-07
8	13537-470-08 (inactivated)
9	13537-471-09
10	13537-471-10 (inactivated)
11	13537-472-11
12	13537-472-12 (inactivated)
13	13537-473-13
14	13537-473-14 (inactivated)
15	13537-474-15
16	13537-474-16 (inactivated)

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