ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE DEEP- titanium dioxide, zinc oxide cream 
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE FAIR LIGHT- titanium dioxide, zinc oxide cream 
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE NEUTRAL TAN- titanium dioxide, zinc oxide cream 
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE FAIR- titanium dioxide, zinc oxide cream 
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE LIGHT- titanium dioxide, zinc oxide cream 
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE MEDIUM TAN- titanium dioxide, zinc oxide cream 
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE RICH- titanium dioxide, zinc oxide cream 
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE LIGHT MEDIUM- titanium dioxide, zinc oxide cream 
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE MEDIUM- titanium dioxide, zinc oxide cream 
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE NEUTRAL MEDIUM- titanium dioxide, zinc oxide cream 
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE TAN- titanium dioxide, zinc oxide cream 
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE RICH HONEY- titanium dioxide, zinc oxide cream 
Beauty Manufacturing Solutions Corp.

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.

----------

ITC Bye Bye Foundation Full Coverage Moisturizer Oil-Free Matte

Titanium Dioxide 7.4%

Zinc Oxide 6.3%

Sunscreen

For external use only

On damaged or broken skin

Keep out of eyes. Rinse with water to remove.

if rash occurs

If swallowed, get medical help or contact a Poison Control Center right away.

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk,

regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

● limit time in the sun, especially from 10 a.m. – 2 p.m.

● wear long-sleeved shirts, pants, hats, and sunglasses

● children under 6 months of age: Ask a doctor

protect the product in this container from excessive heat and direct sun

water, dimethicone, butylene glycol dicaprylate/dicaprate, butylene glycol, cyclopentasiloxane, dimethicone/vinyl dimethicone crosspolymer, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethicone, snail secretion filtrate, sodium chloride, bis-diglyceryl polyacyladipate-2, aluminum hydroxide, stearic acid, disteardimonium hectorite, sorbitan isostearate, polyglyceryl-4 isostearate, hexyl laurate, triethoxycaprylylsilane, triethyl citrate, ethyl hexanediol, sodium benzoate, phenoxyethanol, potassium sorbate, polymethylsilsesquioxane, tocopheryl acetate, disodium EDTA, canadian colloidal clay, moroccan lava clay, avena sativa (oat) kernel extract, glycerin, niacinamide, curcuma longa (turmeric) root extract, sulfur, cholesterol, anthemis nobilis flower water, perfluorohexane, persea gratissima (avocado) fruit extract, maltodextrin, 1,2-hexanediol, vitis vinifera (grape) seed extract, camellia sinensis leaf extract, salix alba (willow) bark extract, magnolia kobus bark extract, chrysanthemum indicum flower extract, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, glycine soja (soybean) sprout extract, perfluorodecalin, silk extract, hydrolyzed silk, aloe barbadensis leaf extract, perfluoromethylcyclopentane, citric acid, olea europaea (olive) leaf extract, artemisia princeps leaf extract, cinnamomum cassia bark extract, pueraria lobata root extract, diospyros kaki leaf extract, morus alba fruit extract, steareth-20, melaleuca alternifolia (tea tree) flower/leaf/stem extract, punica granatum fruit juice, hydrolyzed collagen, ethylhexylglycerin, charcoal powder, lactobacillus/honeysuckle flower/licorice root/morus alba root/pueraria lobata root/schisandra chinensis fruit/scutellaria baicalensis root/sophora japonica flower extract ferment filtrate, chlorhexidine digluconate, n-hydroxysuccinimide, sodium citrate, palmitoyl tripeptide-1, hydrolyzed hyaluronic acid, chrysin, palmitoyl tetrapeptide-7, biotin; may contain: iron oxides, titanium dioxide

Call 800-620-3950

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ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE DEEP 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-137
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
WATER (UNII: 059QF0KO0R)  
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ADENOSINE (UNII: K72T3FS567)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
STEARETH-20 (UNII: L0Q8IK9E08)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
HYALURONIC ACID (UNII: S270N0TRQY)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CHRYSIN (UNII: 3CN01F5ZJ5)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
AVOCADO (UNII: SDS87L369F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-137-011 in 1 CARTON06/01/2019
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2019
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE FAIR LIGHT 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-127
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
WATER (UNII: 059QF0KO0R)  
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ADENOSINE (UNII: K72T3FS567)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
STEARETH-20 (UNII: L0Q8IK9E08)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
HYALURONIC ACID (UNII: S270N0TRQY)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CHRYSIN (UNII: 3CN01F5ZJ5)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
AVOCADO (UNII: SDS87L369F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-127-011 in 1 CARTON06/01/2019
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2019
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE NEUTRAL TAN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-133
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
WATER (UNII: 059QF0KO0R)  
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ADENOSINE (UNII: K72T3FS567)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
STEARETH-20 (UNII: L0Q8IK9E08)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
HYALURONIC ACID (UNII: S270N0TRQY)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CHRYSIN (UNII: 3CN01F5ZJ5)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
AVOCADO (UNII: SDS87L369F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-133-011 in 1 CARTON06/01/2019
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2019
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE FAIR 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-126
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
WATER (UNII: 059QF0KO0R)  
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
AVOCADO (UNII: SDS87L369F)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ADENOSINE (UNII: K72T3FS567)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
STEARETH-20 (UNII: L0Q8IK9E08)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
HYALURONIC ACID (UNII: S270N0TRQY)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CHRYSIN (UNII: 3CN01F5ZJ5)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-126-011 in 1 CARTON06/01/2019
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2019
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE LIGHT 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-128
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
WATER (UNII: 059QF0KO0R)  
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ADENOSINE (UNII: K72T3FS567)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
STEARETH-20 (UNII: L0Q8IK9E08)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
HYALURONIC ACID (UNII: S270N0TRQY)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CHRYSIN (UNII: 3CN01F5ZJ5)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
AVOCADO (UNII: SDS87L369F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-128-011 in 1 CARTON06/01/2019
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2019
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE MEDIUM TAN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-132
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
WATER (UNII: 059QF0KO0R)  
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ADENOSINE (UNII: K72T3FS567)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
STEARETH-20 (UNII: L0Q8IK9E08)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
HYALURONIC ACID (UNII: S270N0TRQY)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CHRYSIN (UNII: 3CN01F5ZJ5)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
AVOCADO (UNII: SDS87L369F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-132-011 in 1 CARTON06/01/2019
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2019
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE RICH 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-135
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
WATER (UNII: 059QF0KO0R)  
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ADENOSINE (UNII: K72T3FS567)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
STEARETH-20 (UNII: L0Q8IK9E08)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
HYALURONIC ACID (UNII: S270N0TRQY)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CHRYSIN (UNII: 3CN01F5ZJ5)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
AVOCADO (UNII: SDS87L369F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-135-011 in 1 CARTON06/01/2019
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2019
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE LIGHT MEDIUM 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
WATER (UNII: 059QF0KO0R)  
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ADENOSINE (UNII: K72T3FS567)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
STEARETH-20 (UNII: L0Q8IK9E08)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
HYALURONIC ACID (UNII: S270N0TRQY)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CHRYSIN (UNII: 3CN01F5ZJ5)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
AVOCADO (UNII: SDS87L369F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-129-011 in 1 CARTON06/01/2019
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2019
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE MEDIUM 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-130
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
WATER (UNII: 059QF0KO0R)  
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ADENOSINE (UNII: K72T3FS567)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
STEARETH-20 (UNII: L0Q8IK9E08)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
HYALURONIC ACID (UNII: S270N0TRQY)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CHRYSIN (UNII: 3CN01F5ZJ5)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
AVOCADO (UNII: SDS87L369F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-130-011 in 1 CARTON06/01/2019
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2019
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE NEUTRAL MEDIUM 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-131
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
WATER (UNII: 059QF0KO0R)  
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ADENOSINE (UNII: K72T3FS567)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
STEARETH-20 (UNII: L0Q8IK9E08)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
HYALURONIC ACID (UNII: S270N0TRQY)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CHRYSIN (UNII: 3CN01F5ZJ5)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
AVOCADO (UNII: SDS87L369F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-131-011 in 1 CARTON06/01/2019
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2019
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE TAN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-134
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
WATER (UNII: 059QF0KO0R)  
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ADENOSINE (UNII: K72T3FS567)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
STEARETH-20 (UNII: L0Q8IK9E08)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
HYALURONIC ACID (UNII: S270N0TRQY)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CHRYSIN (UNII: 3CN01F5ZJ5)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
AVOCADO (UNII: SDS87L369F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-134-011 in 1 CARTON06/01/2019
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2019
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE RICH HONEY 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-136
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
WATER (UNII: 059QF0KO0R)  
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ADENOSINE (UNII: K72T3FS567)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
STEARETH-20 (UNII: L0Q8IK9E08)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
HYALURONIC ACID (UNII: S270N0TRQY)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CHRYSIN (UNII: 3CN01F5ZJ5)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
AVOCADO (UNII: SDS87L369F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-136-011 in 1 CARTON06/01/2019
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2019
Labeler - Beauty Manufacturing Solutions Corp. (783200723)
Registrant - Beauty Manufacturing Solutions Corp. (783200723)
Establishment
NameAddressID/FEIBusiness Operations
Beauty Manufacturing Solutions Corp.783200723manufacture(11090-126, 11090-127, 11090-128, 11090-129, 11090-130, 11090-131, 11090-132, 11090-133, 11090-134, 11090-135, 11090-136, 11090-137)

Revised: 2/2022
Document Id: d888be25-be1c-e92b-e053-2995a90aef82
Set id: d888be25-be1b-e92b-e053-2995a90aef82
Version: 1
Effective Time: 20220221
 
Beauty Manufacturing Solutions Corp.