DailyMed - 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

NDC Code(s): 11090-126-01, 11090-127-01, 11090-128-01, 11090-129-01, view more
11090-130-01, 11090-131-01, 11090-132-01, 11090-133-01, 11090-134-01, 11090-135-01, 11090-136-01, 11090-137-01
Packager: Beauty Manufacturing Solutions Corp.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 21, 2022

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

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ACTIVE INGREDIENT

Titanium Dioxide 7.4%

Zinc Oxide 6.3%
PURPOSE

Sunscreen
INDICATIONS & USAGE
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
WARNINGS

For external use only
DO NOT USE
DO NOT USE

On damaged or broken skin
WHEN USING

Keep out of eyes. Rinse with water to remove.
STOP USE

if rash occurs
KEEP OUT OF REACH OF CHILDREN

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

● 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
OTHER SAFETY INFORMATION

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

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
QUESTIONS

Call 800-620-3950
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INGREDIENTS AND APPEARANCE

ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE DEEP
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-137
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.4 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-137-01	1 in 1 CARTON	06/01/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/01/2019

ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE FAIR LIGHT
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-127
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.4 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-127-01	1 in 1 CARTON	06/01/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/01/2019

ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE NEUTRAL TAN
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-133
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.4 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-133-01	1 in 1 CARTON	06/01/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/01/2019

ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE FAIR
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-126
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.4 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-126-01	1 in 1 CARTON	06/01/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/01/2019

ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE LIGHT
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-128
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.4 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-128-01	1 in 1 CARTON	06/01/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/01/2019

ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE MEDIUM TAN
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-132
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.4 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-132-01	1 in 1 CARTON	06/01/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/01/2019

ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE RICH
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-135
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.4 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-135-01	1 in 1 CARTON	06/01/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/01/2019

ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE LIGHT MEDIUM
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-129
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.4 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-129-01	1 in 1 CARTON	06/01/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/01/2019

ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE MEDIUM
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-130
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.4 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-130-01	1 in 1 CARTON	06/01/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/01/2019

ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE NEUTRAL MEDIUM
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-131
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.4 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-131-01	1 in 1 CARTON	06/01/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/01/2019

ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE TAN
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-134
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.4 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-134-01	1 in 1 CARTON	06/01/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/01/2019

ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE RICH HONEY
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-136
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.4 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-136-01	1 in 1 CARTON	06/01/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/01/2019

Labeler - Beauty Manufacturing Solutions Corp. (783200723)

Registrant - Beauty Manufacturing Solutions Corp. (783200723)

Name	Address	ID/FEI	Business Operations
Establishment
Beauty Manufacturing Solutions Corp.		783200723	manufacture(11090-126, 11090-127, 11090-128, 11090-129, 11090-130, 11090-131, 11090-132, 11090-133, 11090-134, 11090-135, 11090-136, 11090-137)

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	NDC
1	11090-126-01
2	11090-127-01
3	11090-128-01
4	11090-129-01
5	11090-130-01
6	11090-131-01
7	11090-132-01
8	11090-133-01
9	11090-134-01
10	11090-135-01
11	11090-136-01
12	11090-137-01

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