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

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

Drug Labeling and Warnings

Drug Details

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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 DUSTY RED- octinoxate lipstick 
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 BRONZ- 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 SUGAR POP- octinoxate lipstick 
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 SOLARIUM- octinoxate lipstick 
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 SUMMER NUDE- octinoxate lipstick 
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 HOT SUMMER- octinoxate lipstick 
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ARENA DORADA- 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 VELVET ROSE- octinoxate lipstick 
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 FUEGO COLORADO- 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 BURDEO NIGHT- octinoxate lipstick 
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 HONEY NUDE- octinoxate lipstick 
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 NATIVE NUDE- 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 WEST MALVA- octinoxate lipstick 
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ORQUIDEA PINK- 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, 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

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

ambre

Product Packaging - Burdeo Night

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

burdeo night

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 - Dusty Red

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

dusty red

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 - Honey Nude

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

honey nude

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 - Sugar Pop

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

sugar pop

Product Packaging - Summer Nude

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

summer nude

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 - Velvet Rose

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

velvet rose

Product Packaging - West Malva

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

west malva

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 - Bronz

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

bronz

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 - Hot Summer

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

hot summer

Product Packaging - Native Nude

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

native nude

Product Packaging - Solarium

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

solarium

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 - Arena Dorada

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

arena dorada

Product Packaging - Fuego Colorado

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

fuego colorado

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

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ROSA TOSCANA 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0024
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0024-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 AMBRE 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0022-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 DUSTY RED 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0039
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0039-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 BRONZ 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0043
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0043-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 TERCIOPELO NEGRO 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0021-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 SUGAR POP 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0034
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0034-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 SOLARIUM 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0046
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
GERANIOL (UNII: L837108USY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0046-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 SUMMER NUDE 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0044
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0044-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 HOT SUMMER 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0045
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
CASTOR OIL (UNII: D5340Y2I9G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0045-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ARENA DORADA 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0047
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0047-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ULTRA RED 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0027
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0027-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 CREME NUDE 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0026
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0026-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 TIERRA DE ROSAS 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0029
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0029-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 BERRY WINE 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0030-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 CLASSIC RED 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0032
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0032-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 VELVET ROSE 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0033-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 FUEGO COLORADO 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0038
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0038-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 TENTACION 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0023-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 LADY MALBEC 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0035-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 BURDEO NIGHT 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0036
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0036-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 HONEY NUDE 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0037
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0037-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 NATIVE NUDE 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0040-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 GUINDA ETNICO 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0025-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 CHOCOLAT 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0028
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0028-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 WEST MALVA 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0042
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0042-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ORQUIDEA PINK 
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 23319-0031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 23319-0031-11 in 1 CARTON11/15/2018
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/15/2018
Labeler - Yanbal USA, Inc. (001801369)
Establishment
NameAddressID/FEIBusiness Operations
Yanbal de Colombia S.A.S.880215657manufacture(23319-0021, 23319-0022, 23319-0023, 23319-0024, 23319-0025, 23319-0026, 23319-0027, 23319-0028, 23319-0029, 23319-0030, 23319-0031, 23319-0032, 23319-0033, 23319-0034, 23319-0035, 23319-0036, 23319-0037, 23319-0038, 23319-0039, 23319-0040, 23319-0042, 23319-0043, 23319-0044, 23319-0045, 23319-0046, 23319-0047)

Revised: 10/2018
 
Yanbal USA, Inc.


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