Label: 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
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NDC Code(s):
11090-126-01,
11090-127-01,
11090-128-01,
11090-129-01, view more11090-130-01, 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)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
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
-
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
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE DEEP
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-137 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/01/2019 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE FAIR LIGHT
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-127 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/01/2019 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE NEUTRAL TAN
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-133 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/01/2019 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE FAIR
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-126 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/01/2019 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE LIGHT
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-128 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/01/2019 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE MEDIUM TAN
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-132 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/01/2019 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE RICH
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-135 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/01/2019 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE LIGHT MEDIUM
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-129 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/01/2019 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE MEDIUM
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-130 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/01/2019 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE NEUTRAL MEDIUM
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-131 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/01/2019 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE TAN
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-134 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/01/2019 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL-FREE MATTE RICH HONEY
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-136 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/01/2019 Labeler - Beauty Manufacturing Solutions Corp. (783200723) Registrant - Beauty Manufacturing Solutions Corp. (783200723) Establishment Name Address ID/FEI Business Operations 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)