YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ESTRELLA ROSA- octinoxate lipstick YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ROSA TOSCANA- octinoxate lipstick YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 AMBRE- octinoxate lipstick YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE .......UNSCREEN SPF 15 GUINDA ETNICO- octinoxate lipstick YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 CHOCOLAT- octinoxate lipstick YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ORQUIDEA PINK- octinoxate lipstick YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 DESTELLO ROJO- octinoxate lipstick

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 DESTELLO ROJO by

Drug Labeling and Warnings

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 DESTELLO ROJO by is a Otc medication manufactured, distributed, or labeled by Yanbal USA, Inc., Yanbal de Colombia S.A.S.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Octinoxate 4%

Purpose: Sunscreen

Use

• 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 prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

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

Directions

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• children under 6 months: Ask a doctor.

Other information

• protect this product from excessive heat and direct sun
• report serious adverse event to Report Reaction, LLC, P.O. Box 22, Plainsboro, NJ 08536-0222

Inactive ingredients

ISOSTEARYL ISOSTEARATE, RICINUS COMMUNIS (CASTOR) SEED OIL, BIS-PEG-12 DIMETHICONE BEESWAX, CANDELILLA CERA / EUPHORBIA CERIFERA (CANDELILLA) WAX, POLYETHYLENE, BUTYLOCTYL SALICYLATE, HYDROGENATED POLYISOBUTENE, C10-30 CHOLESTEROL / LANOSTEROL ESTERS, HYDROGENATED POLYDECENE, BIS-DIGLYCERYL POLYACYLADIPATE-2, AQUA / WATER, POLYGLYCERYL-10 HEPTAHYDROXYSTEARATE, CERA MICROCRISTALLINA / MICROCRYSTALLINE WAX, CETYL ALCOHOL, POLYAMIDE-5, CAPRYLYL GLYCOL, TOCOPHEROL, PARFUM / FRAGRANCE, PHENOXYETHANOL, OLIVE GLYCERIDES, ISOCETYL STEAROYL STEARATE, HEXYLENE GLYCOL, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, GLYCERIN, MYRICA PUBESCENS FRUIT WAX, HEXYL CINNAMIC ALDEHYDE, BENZYL SALICYLATE, LINALOOL, CITRONELLOL, HYDROXYCITRONELLAL, GERANIOL, CERAMIDE-3, BENZYL BENZOATE, LIMONENE, BENZYL CINNAMATE, BHT, ALPHA-ISOMETHYL IONONE, SYNTHETIC FLUORPHLOGOPITE, TIN OXIDE, SILICA, MICA, TITANIUM DIOXIDE (CI 77891), YELLOW 6 LAKE (CI 15985), RED 27 LAKE (CI 45410), RED 6 LAKE (CI 15850), RED 30 LAKE (CI 73360), IRON OXIDES (CI 77491), RED 7 LAKE (CI 15850), YELLOW 5 LAKE (CI 19140), RED 33 LAKE (CI 17200), MANGANESE VIOLET (CI 77742), YELLOW 10 LAKE (CI 47005), IRON OXIDES (CI 77499), IRON OXIDES (CI 77492), BLUE 1 LAKE (CI 42090), BRONZE POWDER (CI 77400), CARMINE (CI 75470), BISMUTH OXYCHLORIDE (CI 77163), RED 40 LAKE (CI 16035).

Company Information

Distributed by YANBAL USA INC. 1341 W Newport Center Dr. Deerfield Beach, FL 33442

Product Packaging - Ambre

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

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SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

Product Packaging - Chocolat

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

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Product Packaging - Creme Nude

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

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Product Packaging - Guinda Etnico

YANBAL

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Product Packaging - Lady Malbec

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

Product Packaging - Orquidea Pink

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

Product Packaging - Rosa Toscana

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

Product Packaging - Terciopelo Negro

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

Product Packaging - Tierra de Rosas

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

Product Packaging - Berry Wine

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

Product Packaging - Classic Red

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

Product Packaging - Tentacion

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

Product Packaging - Ultra Red

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

Product Packaging - Estrella Rosa

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

Product Packaging - Destello Rojo

ANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

Product Packaging - Zen on Fire

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

Product Packaging - Vibrant Ross

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

Product Packaging - Sol de Arena

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

INGREDIENTS AND APPEARANCE

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ESTRELLA ROSA 
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0048
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
CARMINIC ACID (UNII: CID8Z8N95N)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL CINNAMATE (UNII: V67O3RO97U)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
COPPER (UNII: 789U1901C5)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CASTOR OIL (UNII: D5340Y2I9G)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
MICA (UNII: V8A1AW0880)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
GLYCERIN (UNII: PDC6A3C0OX)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
D&C RED NO. 6 (UNII: 481744AI4O)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CERAMIDE 3 (UNII: 4370DF050B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
FERRIC OXIDE RED (UNII: 1K09F3G675)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0048-1	1 in 1 CARTON	10/01/2019
1		4 g 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 not final	part352	10/01/2019

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ROSA TOSCANA 
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL CINNAMATE (UNII: V67O3RO97U)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
COPPER (UNII: 789U1901C5)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
CASTOR OIL (UNII: D5340Y2I9G)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
MICA (UNII: V8A1AW0880)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
GLYCERIN (UNII: PDC6A3C0OX)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
D&C RED NO. 6 (UNII: 481744AI4O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CERAMIDE 3 (UNII: 4370DF050B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0024-1	1 in 1 CARTON	11/15/2018
1		4 g 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 not final	part352	11/15/2018

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 AMBRE 
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
CARMINIC ACID (UNII: CID8Z8N95N)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL CINNAMATE (UNII: V67O3RO97U)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
COPPER (UNII: 789U1901C5)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
CASTOR OIL (UNII: D5340Y2I9G)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
MICA (UNII: V8A1AW0880)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
GLYCERIN (UNII: PDC6A3C0OX)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
D&C RED NO. 6 (UNII: 481744AI4O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CERAMIDE 3 (UNII: 4370DF050B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0022-1	1 in 1 CARTON	11/15/2018
1		4 g 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 not final	part352	11/15/2018

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 TERCIOPELO NEGRO 
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
CARMINIC ACID (UNII: CID8Z8N95N)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL CINNAMATE (UNII: V67O3RO97U)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
COPPER (UNII: 789U1901C5)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
CASTOR OIL (UNII: D5340Y2I9G)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
MICA (UNII: V8A1AW0880)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
GLYCERIN (UNII: PDC6A3C0OX)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
D&C RED NO. 6 (UNII: 481744AI4O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CERAMIDE 3 (UNII: 4370DF050B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0021-1	1 in 1 CARTON	11/15/2018
1		4 g 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 not final	part352	11/15/2018

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ULTRA RED 
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
CARMINIC ACID (UNII: CID8Z8N95N)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL CINNAMATE (UNII: V67O3RO97U)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
COPPER (UNII: 789U1901C5)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CASTOR OIL (UNII: D5340Y2I9G)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
MICA (UNII: V8A1AW0880)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
GLYCERIN (UNII: PDC6A3C0OX)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
D&C RED NO. 6 (UNII: 481744AI4O)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CERAMIDE 3 (UNII: 4370DF050B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0027-1	1 in 1 CARTON	11/15/2018
1		4 g 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 not final	part352	11/15/2018

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 CREME NUDE 
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
CARMINIC ACID (UNII: CID8Z8N95N)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL CINNAMATE (UNII: V67O3RO97U)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
COPPER (UNII: 789U1901C5)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
CASTOR OIL (UNII: D5340Y2I9G)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
MICA (UNII: V8A1AW0880)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
GLYCERIN (UNII: PDC6A3C0OX)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
D&C RED NO. 6 (UNII: 481744AI4O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CERAMIDE 3 (UNII: 4370DF050B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0026-1	1 in 1 CARTON	11/15/2018
1		4 g 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 not final	part352	11/15/2018

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 TIERRA DE ROSAS 
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
CARMINIC ACID (UNII: CID8Z8N95N)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL CINNAMATE (UNII: V67O3RO97U)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
COPPER (UNII: 789U1901C5)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CASTOR OIL (UNII: D5340Y2I9G)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
MICA (UNII: V8A1AW0880)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
GLYCERIN (UNII: PDC6A3C0OX)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
D&C RED NO. 6 (UNII: 481744AI4O)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CERAMIDE 3 (UNII: 4370DF050B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
FERRIC OXIDE RED (UNII: 1K09F3G675)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0029-1	1 in 1 CARTON	11/15/2018
1		4 g 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 not final	part352	11/15/2018

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 BERRY WINE 
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
CARMINIC ACID (UNII: CID8Z8N95N)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL CINNAMATE (UNII: V67O3RO97U)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
COPPER (UNII: 789U1901C5)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CASTOR OIL (UNII: D5340Y2I9G)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
MICA (UNII: V8A1AW0880)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
GLYCERIN (UNII: PDC6A3C0OX)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
D&C RED NO. 6 (UNII: 481744AI4O)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CERAMIDE 3 (UNII: 4370DF050B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
FERRIC OXIDE RED (UNII: 1K09F3G675)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0030-1	1 in 1 CARTON	11/15/2018
1		4 g 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 not final	part352	11/15/2018

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 CLASSIC RED 
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
CARMINIC ACID (UNII: CID8Z8N95N)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL CINNAMATE (UNII: V67O3RO97U)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
COPPER (UNII: 789U1901C5)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CASTOR OIL (UNII: D5340Y2I9G)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
MICA (UNII: V8A1AW0880)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
GLYCERIN (UNII: PDC6A3C0OX)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
D&C RED NO. 6 (UNII: 481744AI4O)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CERAMIDE 3 (UNII: 4370DF050B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
FERRIC OXIDE RED (UNII: 1K09F3G675)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0032-1	1 in 1 CARTON	11/15/2018
1		4 g 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 not final	part352	11/15/2018

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 TENTACION 
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
CARMINIC ACID (UNII: CID8Z8N95N)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL CINNAMATE (UNII: V67O3RO97U)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
COPPER (UNII: 789U1901C5)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
CASTOR OIL (UNII: D5340Y2I9G)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
MICA (UNII: V8A1AW0880)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
GLYCERIN (UNII: PDC6A3C0OX)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CERAMIDE 3 (UNII: 4370DF050B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
D&C RED NO. 6 (UNII: 481744AI4O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0023-1	1 in 1 CARTON	11/15/2018
1		4 g 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 not final	part352	11/15/2018

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 LADY MALBEC 
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CASTOR OIL (UNII: D5340Y2I9G)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
MICA (UNII: V8A1AW0880)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
GLYCERIN (UNII: PDC6A3C0OX)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
D&C RED NO. 6 (UNII: 481744AI4O)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CERAMIDE 3 (UNII: 4370DF050B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
FERRIC OXIDE RED (UNII: 1K09F3G675)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
CARMINIC ACID (UNII: CID8Z8N95N)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL CINNAMATE (UNII: V67O3RO97U)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
COPPER (UNII: 789U1901C5)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0035-1	1 in 1 CARTON	11/15/2018
1		4 g 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 not final	part352	11/15/2018

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 GUINDA ETNICO 
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
CARMINIC ACID (UNII: CID8Z8N95N)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL CINNAMATE (UNII: V67O3RO97U)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
COPPER (UNII: 789U1901C5)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
CASTOR OIL (UNII: D5340Y2I9G)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
MICA (UNII: V8A1AW0880)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
GLYCERIN (UNII: PDC6A3C0OX)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
D&C RED NO. 6 (UNII: 481744AI4O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CERAMIDE 3 (UNII: 4370DF050B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0025-1	1 in 1 CARTON	11/15/2018
1		4 g 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 not final	part352	11/15/2018

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 CHOCOLAT 
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
CARMINIC ACID (UNII: CID8Z8N95N)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL CINNAMATE (UNII: V67O3RO97U)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
COPPER (UNII: 789U1901C5)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CASTOR OIL (UNII: D5340Y2I9G)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
MICA (UNII: V8A1AW0880)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
GLYCERIN (UNII: PDC6A3C0OX)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
D&C RED NO. 6 (UNII: 481744AI4O)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CERAMIDE 3 (UNII: 4370DF050B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
FERRIC OXIDE RED (UNII: 1K09F3G675)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0028-1	1 in 1 CARTON	11/15/2018
1		4 g 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 not final	part352	11/15/2018

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ORQUIDEA PINK 
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
COPPER (UNII: 789U1901C5)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CASTOR OIL (UNII: D5340Y2I9G)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
MICA (UNII: V8A1AW0880)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
GLYCERIN (UNII: PDC6A3C0OX)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
D&C RED NO. 6 (UNII: 481744AI4O)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CERAMIDE 3 (UNII: 4370DF050B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
FERRIC OXIDE RED (UNII: 1K09F3G675)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
CARMINIC ACID (UNII: CID8Z8N95N)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL CINNAMATE (UNII: V67O3RO97U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0031-1	1 in 1 CARTON	11/15/2018
1		4 g 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 not final	part352	11/15/2018

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 DESTELLO ROJO 
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
CARMINIC ACID (UNII: CID8Z8N95N)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL CINNAMATE (UNII: V67O3RO97U)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
COPPER (UNII: 789U1901C5)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CASTOR OIL (UNII: D5340Y2I9G)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
MICA (UNII: V8A1AW0880)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
GLYCERIN (UNII: PDC6A3C0OX)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
D&C RED NO. 6 (UNII: 481744AI4O)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CERAMIDE 3 (UNII: 4370DF050B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
FERRIC OXIDE RED (UNII: 1K09F3G675)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0050-1	1 in 1 CARTON	10/01/2019
1		4 g 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 not final	part352	10/01/2019

Labeler - Yanbal USA, Inc. (001801369)

Establishment
Name	Address	ID/FEI	Business Operations
Yanbal de Colombia S.A.S.		880215657	manufacture(23319-0021, 23319-0022, 23319-0023, 23319-0024, 23319-0025, 23319-0026, 23319-0027, 23319-0028, 23319-0029, 23319-0030, 23319-0031, 23319-0032, 23319-0035, 23319-0048, 23319-0050)