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 COLOR SUNSCREEN SPF 15 TERCIOPELO NEGRO- octinoxate lipstick
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ULTRA RED- octinoxate lipstick
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 CREME NUDE- octinoxate lipstick
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 TIERRA DE ROSAS- octinoxate lipstick
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 BERRY WINE- octinoxate lipstick
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 CLASSIC RED- octinoxate lipstick
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 TENTACION- octinoxate lipstick
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 LADY MALBEC- octinoxate lipstick
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN 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 USA, Inc.

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.

----------

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR LIPSTICK SUNSCREEN SPF 15

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).

Product Packaging - Ambre

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

ambre

Product Packaging - Chocolat

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

chocolat

Product Packaging - Creme Nude

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

creme nude

Product Packaging - Guinda Etnico

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

guinda etnico

Product Packaging - Lady Malbec

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

lady malbec

Product Packaging - Orquidea Pink

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

orquidea pink

Product Packaging - Rosa Toscana

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

rosa toscana

Product Packaging - Terciopelo Negro

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

terciopelo negro

Product Packaging - Tierra de Rosas

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

tierra de rosas

Product Packaging - Berry Wine

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

berry wine

Product Packaging - Classic Red

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

classic red

Product Packaging - Tentacion

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

tentacion

Product Packaging - Ultra Red

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

ultra red

Product Packaging - Estrella Rosa

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

estrella rosa

Product Packaging - Destello Rojo

ANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

destello rojo

Product Packaging - Zen on Fire

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

zen on fire

Product Packaging - Vibrant Ross

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

vibrant ross

Product Packaging - Sol de Arena

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

sol de arena

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/01/2019	02/01/2022

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

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

Ingredient Name	Strength
Inactive Ingredients
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL CINNAMATE (UNII: V67O3RO97U)
GERANIOL (UNII: L837108USY)
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)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:23319-0024-1	1 in 1 CARTON	11/15/2018	08/01/2021
1		4 g 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 not final	part352	11/15/2018	08/01/2021

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:23319-0022-1	1 in 1 CARTON	11/15/2018	08/01/2021
1		4 g 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 not final	part352	11/15/2018	08/01/2021

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:23319-0021-1	1 in 1 CARTON	11/15/2018	08/01/2021
1		4 g 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 not final	part352	11/15/2018	08/01/2021

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

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

Ingredient Name	Strength
Inactive Ingredients
.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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/15/2018	08/01/2021

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/15/2018	07/01/2021

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/15/2018	07/01/2021

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/15/2018	08/01/2021

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/15/2018	08/01/2021

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:23319-0023-1	1 in 1 CARTON	11/15/2018	08/01/2021
1		4 g 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 not final	part352	11/15/2018	08/01/2021

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/15/2018	08/01/2021

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:23319-0025-1	1 in 1 CARTON	11/15/2018	08/01/2021
1		4 g 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 not final	part352	11/15/2018	08/01/2021

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/15/2018	07/01/2021

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/15/2018	08/01/2021

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/01/2019	03/01/2022

Labeler - Yanbal USA, Inc. (001801369)

Name	Address	ID/FEI	Business Operations
Establishment
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)

Revised: 11/2020

Document Id: b4f1775b-5df5-4b67-e053-2a95a90a2b67

Set id: 78eb9610-a67d-ad72-e053-2991aa0ad1da

Version: 8

Effective Time: 20201125

Yanbal USA, Inc.

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR LIPSTICK SUNSCREEN SPF 15

Active ingredient

Use

Warnings

Directions

Other information

Inactive ingredients

Company Information

Product Packaging - Ambre

Product Packaging - Chocolat

Product Packaging - Creme Nude

Product Packaging - Guinda Etnico

Product Packaging - Lady Malbec

Product Packaging - Orquidea Pink

Product Packaging - Rosa Toscana

Product Packaging - Terciopelo Negro

Product Packaging - Tierra de Rosas

Product Packaging - Berry Wine

Product Packaging - Classic Red

Product Packaging - Tentacion

Product Packaging - Ultra Red

Product Packaging - Estrella Rosa

Product Packaging - Destello Rojo

Product Packaging - Zen on Fire

Product Packaging - Vibrant Ross

Product Packaging - Sol de Arena