BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 FAIR- titanium dioxide and zinc oxide cream BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 LIGHT- titanium dioxide and zinc oxide cream BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 MEDIUM- titanium dioxide and zinc oxide cream BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 MEDIUM TAN- titanium dioxide and zinc oxide cream BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 NEUTRAL TAN- titanium dioxide and zinc oxide cream BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 RICH- titanium dioxide and zinc oxide cream BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 DEEP- titanium dioxide and zinc oxide cream BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 NEUTRAL MEDIUM- titanium dioxide and zinc oxide cream BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 RICH HONEY- titanium dioxide and zinc oxide cream BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 FAIR LIGHT- titanium dioxide and zinc oxide cream BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 LIGHT MEDIUM- titanium dioxide and zinc oxide cream BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 TAN- titanium dioxide and zinc oxide cream
Bye Bye Foundation Full Coverage Moisturizer SPF 50 by
Drug Labeling and Warnings
Bye Bye Foundation Full Coverage Moisturizer SPF 50 by is a Otc medication manufactured, distributed, or labeled by IT COSMETICS, LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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PRINCIPAL DISPLAY PANEL
IT COSMETICS®
Bye Bye Foundation™ Full Coverage Moisturizer SPF 50+
Net Content 30 ml / 1.00 fl.oz
Shades: Fair, Fair Light, Light, Light Medium, Medium, Neutral Medium, Medium Tan, Neutral Tan, Tan, Rich, Deep, Rich Honey
Drug Facts
Active ingredient Purpose
Titanium dioxide 9.0% Sunscreen
Zinc oxide 6.3% SunscreenUses
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 on damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children.
If swallowed, get medical help or contact Poison Control Center right away.Directions
Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hour.
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 information
Protect the product in this container from excessive heat and direct sun.
Questions? Call 800.620.3950Inactive Ingredients
Water, Snail Secretion Filtrate, Phenyl Trimethicone, Dimethicone, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Orbignya Oleifera Seed Oil, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Cyclohexasiloxane, Magnesium Sulfate, Aluminum Hydroxide, Stearic Acid, Polyglyceryl-4 Isostearate, Dimethicone/Vinyl Dimethicone Crosspolymer, Hexyl Laurate, Calcium Stearate, Caprylyl Glycol, Triethoxycaprylylsilane, Ethylhexylglycerin, Citrus Medica Limonum (Lemon) Peel Oil, Tocopheryl Acetate, Sorbitan Isostearate, Phenoxyethanol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, 1,2-Hexanediol, Disodium EDTA, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Aurantifolia (Lime) Oil, Cholesterol, Persea Gratissima (Avocado) Oil, Cholesteryl Oleyl Carbonate, Pinus Sylvestris Leaf Oil, Niacinamide, Punica Granatum Seed Oil, Vitis Vinifera (Grape) Seed Oil, Lactobacillus/Pumpkin Ferment Extract, Polymethylsilsesquioxane, Anthemis Nobilis Flower Water, Lactobacillus/Dipteryx Odorata Seed Ferment Filtrate, Avena Sativa (Oat) Kernel Extract, Panax Ginseng Root Extract*, Eucalyptus Globulus Leaf Oil, Saccharomyces/Rice Ferment Filtrate, Lactobacillus/Kelp Ferment Filtrate, Cholesteryl Nonanoate, Cholesteryl Isostearate, Cholesteryl Chloride, Curcuma Longa (Turmeric) Root Extract, Lactobacillus/Honeysuckle Flower/Licorice Root/Morus Alba Root/Pueraria Lobata Root/Schizandra Chinensis Fruit/Scutellaria Baicalensis Root/Sophora Japonica Flower Extract Ferment Filtrate, Magnolia Kobus Bark Extract, Glycine Soja (Soybean) Sprout Extract, Perfluorohexane, Glycerin, Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Hydrolyzed Silk, Perfluorodecalin, Silk Extract, Olea Europaea (Olive) Leaf Extract, Pentafluoropropane, Steareth-20, Citric Acid, Cocos Nucifera (Coconut) Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Hydrolyzed Collagen, Lactobacillus/Rice Ferment Filtrate, Lactobacillus/Centella Asiatica/Gleditsia Sinensis Thorn/Houttuynia Cordata Extract/Phellodendron Amurense Bark/Polygonum Cuspidatum Root/Prunella Vulgaris/Torilis Japonica Extract Ferment Filtrate, Lactobacillus Ferment, Bacillus/Cordyceps Sinensis/Ganoderma Lucidum/Inonotus Obliquus/Lentinus Edodes/Phellinus Linteus/Schizophyllum Commune/Tricholoma Matsutake Extract Ferment Filtrate, Phaseolus Angularis Seed Extract, Saccharomyces/Camellia Sinensis Extract Ferment Filtrate, Sodium Benzoate, Potassium Sorbate, Chrysanthemum Indicum Flower Extract, Diamond Powder, Caprylhydroxamic Acid, Artemisia Princeps Leaf Extract, Cinnamomum Cassia Bark Extract, Diospyros Kaki Leaf Extract, Morus Alba Fruit Extract, Aloe Barbadensis Leaf Extract, N-Hydroxysuccinimide, Pantothenic Acid, Biotin, Thiamine HCl, Retinyl Palmitate, Tocopherol, Niacin, Carnitine HCl, Ascorbic Acid, Riboflavin, Folic Acid, Palmitoyl Oligopeptide, Chrysin, Hydrolyzed Hyaluronic Acid, Palmitoyl Tetrapeptide-7, Chlorhexidine digluconate, Iron Oxides (CI 77492, CI 77491, CI 77499).Fair
Fair Light
Light
Light Medium
Medium
Neutral Medium
Medium Tan
Neutral Tan
Tan
Rich
Deep
Rich Honey
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INGREDIENTS AND APPEARANCE
BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 FAIR
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 69259-0399 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 9.0 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI) Butyloctyl Salicylate (UNII: 2EH13UN8D3) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Hexyl Laurate (UNII: 4CG9F9W01Q) Stearic Acid (UNII: 4ELV7Z65AP) Calcium Stearate (UNII: 776XM7047L) Caprylyl Glycol (UNII: 00YIU5438U) Triethoxycaprylylsilane (UNII: LDC331P08E) Ethylhexylglycerin (UNII: 147D247K3P) Sorbitan Isostearate (UNII: 01S2G2C1E4) Phenoxyethanol (UNII: HIE492ZZ3T) 1,2-Hexanediol (UNII: TR046Y3K1G) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) LIME OIL (UNII: UZH29XGA8G) GRAPE SEED OIL (UNII: 930MLC8XGG) Punica Granatum Seed Oil (UNII: 0UI45XV0T6) AVOCADO OIL (UNII: 6VNO72PFC1) Niacinamide (UNII: 25X51I8RD4) WHITE PINE OIL (UNII: HA5CX6676U) GRAPEFRUIT OIL (UNII: YR377U58W9) Cholesterol (UNII: 97C5T2UQ7J) Glycerin (UNII: PDC6A3C0OX) EUCALYPTUS OIL (UNII: 2R04ONI662) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SOYBEAN OIL (UNII: 241ATL177A) Pentafluoropropane (UNII: TA9UOF49CY) TURMERIC (UNII: 856YO1Z64F) Steareth-20 (UNII: L0Q8IK9E08) SILK, BASE HYDROLYZED (1000 MW) (UNII: UMQ31C11AY) HYALURONIC ACID (UNII: S270N0TRQY) OATMEAL (UNII: 8PI54V663Y) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Sodium Benzoate (UNII: OJ245FE5EU) Potassium Sorbate (UNII: 1VPU26JZZ4) ALOE VERA LEAF (UNII: ZY81Z83H0X) N-Hydroxysuccinimide (UNII: MJE3791M4T) HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P) Caprylhydroxamic Acid (UNII: UPY805K99W) Tocopherol (UNII: R0ZB2556P8) THIAMINE HYDROCHLORIDE (UNII: M572600E5P) Riboflavin (UNII: TLM2976OFR) RETINOL (UNII: G2SH0XKK91) Pantothenic Acid (UNII: 19F5HK2737) Palmitoyl Oligopeptide (UNII: HO4ZT5S86C) Niacin (UNII: 2679MF687A) Folic Acid (UNII: 935E97BOY8) Chrysin (UNII: 3CN01F5ZJ5) CARNITINE HYDROCHLORIDE, (+)- (UNII: 11X758JML9) Biotin (UNII: 6SO6U10H04) Ascorbic Acid (UNII: PQ6CK8PD0R) Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R) CHLORHEXIDINE (UNII: R4KO0DY52L) BROWN IRON OXIDE (UNII: 1N032N7MFO) CHOLESTERYL OLEYL CARBONATE (UNII: 95LLB1K2WE) CHOLESTERYL NONANOATE (UNII: 4313O7P4XW) CHOLESTERYL ISOSTEARATE (UNII: JD5KDN9464) CHOLESTERYL CHLORIDE (UNII: 39EHZ05V39) Product Characteristics Color brown (Fair) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 69259-0399-1 30 mL in 1 TUBE; Type 0: Not a Combination Product 08/23/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/23/2017 BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 LIGHT
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 69259-0405 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 9.0 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI) Butyloctyl Salicylate (UNII: 2EH13UN8D3) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Hexyl Laurate (UNII: 4CG9F9W01Q) Stearic Acid (UNII: 4ELV7Z65AP) Calcium Stearate (UNII: 776XM7047L) Caprylyl Glycol (UNII: 00YIU5438U) Triethoxycaprylylsilane (UNII: LDC331P08E) Ethylhexylglycerin (UNII: 147D247K3P) Sorbitan Isostearate (UNII: 01S2G2C1E4) Phenoxyethanol (UNII: HIE492ZZ3T) 1,2-Hexanediol (UNII: TR046Y3K1G) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) LIME OIL (UNII: UZH29XGA8G) GRAPE SEED OIL (UNII: 930MLC8XGG) Punica Granatum Seed Oil (UNII: 0UI45XV0T6) AVOCADO OIL (UNII: 6VNO72PFC1) Niacinamide (UNII: 25X51I8RD4) WHITE PINE OIL (UNII: HA5CX6676U) GRAPEFRUIT OIL (UNII: YR377U58W9) Cholesterol (UNII: 97C5T2UQ7J) Glycerin (UNII: PDC6A3C0OX) EUCALYPTUS OIL (UNII: 2R04ONI662) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SOYBEAN OIL (UNII: 241ATL177A) Pentafluoropropane (UNII: TA9UOF49CY) TURMERIC (UNII: 856YO1Z64F) Steareth-20 (UNII: L0Q8IK9E08) SILK, BASE HYDROLYZED (1000 MW) (UNII: UMQ31C11AY) HYALURONIC ACID (UNII: S270N0TRQY) OATMEAL (UNII: 8PI54V663Y) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Sodium Benzoate (UNII: OJ245FE5EU) Potassium Sorbate (UNII: 1VPU26JZZ4) ALOE VERA LEAF (UNII: ZY81Z83H0X) N-Hydroxysuccinimide (UNII: MJE3791M4T) HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P) Caprylhydroxamic Acid (UNII: UPY805K99W) Tocopherol (UNII: R0ZB2556P8) THIAMINE HYDROCHLORIDE (UNII: M572600E5P) Riboflavin (UNII: TLM2976OFR) RETINOL (UNII: G2SH0XKK91) Pantothenic Acid (UNII: 19F5HK2737) Palmitoyl Oligopeptide (UNII: HO4ZT5S86C) Niacin (UNII: 2679MF687A) Folic Acid (UNII: 935E97BOY8) Chrysin (UNII: 3CN01F5ZJ5) CARNITINE HYDROCHLORIDE, (+)- (UNII: 11X758JML9) Biotin (UNII: 6SO6U10H04) Ascorbic Acid (UNII: PQ6CK8PD0R) Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R) CHLORHEXIDINE (UNII: R4KO0DY52L) BROWN IRON OXIDE (UNII: 1N032N7MFO) CHOLESTERYL OLEYL CARBONATE (UNII: 95LLB1K2WE) CHOLESTERYL NONANOATE (UNII: 4313O7P4XW) CHOLESTERYL ISOSTEARATE (UNII: JD5KDN9464) CHOLESTERYL CHLORIDE (UNII: 39EHZ05V39) Product Characteristics Color brown (Light) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 69259-0405-1 30 mL in 1 TUBE; Type 0: Not a Combination Product 08/23/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/23/2017 BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 MEDIUM
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 69259-0412 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 9.0 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI) Butyloctyl Salicylate (UNII: 2EH13UN8D3) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Hexyl Laurate (UNII: 4CG9F9W01Q) Stearic Acid (UNII: 4ELV7Z65AP) Calcium Stearate (UNII: 776XM7047L) Caprylyl Glycol (UNII: 00YIU5438U) Triethoxycaprylylsilane (UNII: LDC331P08E) Ethylhexylglycerin (UNII: 147D247K3P) Sorbitan Isostearate (UNII: 01S2G2C1E4) Phenoxyethanol (UNII: HIE492ZZ3T) 1,2-Hexanediol (UNII: TR046Y3K1G) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) LIME OIL (UNII: UZH29XGA8G) GRAPE SEED OIL (UNII: 930MLC8XGG) Punica Granatum Seed Oil (UNII: 0UI45XV0T6) AVOCADO OIL (UNII: 6VNO72PFC1) Niacinamide (UNII: 25X51I8RD4) WHITE PINE OIL (UNII: HA5CX6676U) GRAPEFRUIT OIL (UNII: YR377U58W9) Cholesterol (UNII: 97C5T2UQ7J) Glycerin (UNII: PDC6A3C0OX) EUCALYPTUS OIL (UNII: 2R04ONI662) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SOYBEAN OIL (UNII: 241ATL177A) Pentafluoropropane (UNII: TA9UOF49CY) TURMERIC (UNII: 856YO1Z64F) Steareth-20 (UNII: L0Q8IK9E08) SILK, BASE HYDROLYZED (1000 MW) (UNII: UMQ31C11AY) HYALURONIC ACID (UNII: S270N0TRQY) OATMEAL (UNII: 8PI54V663Y) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Sodium Benzoate (UNII: OJ245FE5EU) Potassium Sorbate (UNII: 1VPU26JZZ4) ALOE VERA LEAF (UNII: ZY81Z83H0X) N-Hydroxysuccinimide (UNII: MJE3791M4T) HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P) Caprylhydroxamic Acid (UNII: UPY805K99W) Tocopherol (UNII: R0ZB2556P8) THIAMINE HYDROCHLORIDE (UNII: M572600E5P) Riboflavin (UNII: TLM2976OFR) RETINOL (UNII: G2SH0XKK91) Pantothenic Acid (UNII: 19F5HK2737) Palmitoyl Oligopeptide (UNII: HO4ZT5S86C) Niacin (UNII: 2679MF687A) Folic Acid (UNII: 935E97BOY8) Chrysin (UNII: 3CN01F5ZJ5) CARNITINE HYDROCHLORIDE, (+)- (UNII: 11X758JML9) Biotin (UNII: 6SO6U10H04) Ascorbic Acid (UNII: PQ6CK8PD0R) Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R) CHLORHEXIDINE (UNII: R4KO0DY52L) BROWN IRON OXIDE (UNII: 1N032N7MFO) CHOLESTERYL OLEYL CARBONATE (UNII: 95LLB1K2WE) CHOLESTERYL NONANOATE (UNII: 4313O7P4XW) CHOLESTERYL ISOSTEARATE (UNII: JD5KDN9464) CHOLESTERYL CHLORIDE (UNII: 39EHZ05V39) Product Characteristics Color brown (Medium) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 69259-0412-1 30 mL in 1 TUBE; Type 0: Not a Combination Product 08/23/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/23/2017 BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 MEDIUM TAN
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 69259-0429 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 9.0 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI) Butyloctyl Salicylate (UNII: 2EH13UN8D3) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Hexyl Laurate (UNII: 4CG9F9W01Q) Stearic Acid (UNII: 4ELV7Z65AP) Calcium Stearate (UNII: 776XM7047L) Caprylyl Glycol (UNII: 00YIU5438U) Triethoxycaprylylsilane (UNII: LDC331P08E) Ethylhexylglycerin (UNII: 147D247K3P) Sorbitan Isostearate (UNII: 01S2G2C1E4) Phenoxyethanol (UNII: HIE492ZZ3T) 1,2-Hexanediol (UNII: TR046Y3K1G) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) LIME OIL (UNII: UZH29XGA8G) GRAPE SEED OIL (UNII: 930MLC8XGG) Punica Granatum Seed Oil (UNII: 0UI45XV0T6) AVOCADO OIL (UNII: 6VNO72PFC1) Niacinamide (UNII: 25X51I8RD4) WHITE PINE OIL (UNII: HA5CX6676U) GRAPEFRUIT OIL (UNII: YR377U58W9) Cholesterol (UNII: 97C5T2UQ7J) Glycerin (UNII: PDC6A3C0OX) EUCALYPTUS OIL (UNII: 2R04ONI662) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SOYBEAN OIL (UNII: 241ATL177A) Pentafluoropropane (UNII: TA9UOF49CY) TURMERIC (UNII: 856YO1Z64F) Steareth-20 (UNII: L0Q8IK9E08) SILK, BASE HYDROLYZED (1000 MW) (UNII: UMQ31C11AY) HYALURONIC ACID (UNII: S270N0TRQY) OATMEAL (UNII: 8PI54V663Y) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Sodium Benzoate (UNII: OJ245FE5EU) Potassium Sorbate (UNII: 1VPU26JZZ4) ALOE VERA LEAF (UNII: ZY81Z83H0X) N-Hydroxysuccinimide (UNII: MJE3791M4T) HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P) Caprylhydroxamic Acid (UNII: UPY805K99W) Tocopherol (UNII: R0ZB2556P8) THIAMINE HYDROCHLORIDE (UNII: M572600E5P) Riboflavin (UNII: TLM2976OFR) RETINOL (UNII: G2SH0XKK91) Pantothenic Acid (UNII: 19F5HK2737) Palmitoyl Oligopeptide (UNII: HO4ZT5S86C) Niacin (UNII: 2679MF687A) Folic Acid (UNII: 935E97BOY8) Chrysin (UNII: 3CN01F5ZJ5) CARNITINE HYDROCHLORIDE, (+)- (UNII: 11X758JML9) Biotin (UNII: 6SO6U10H04) Ascorbic Acid (UNII: PQ6CK8PD0R) Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R) CHLORHEXIDINE (UNII: R4KO0DY52L) BROWN IRON OXIDE (UNII: 1N032N7MFO) CHOLESTERYL OLEYL CARBONATE (UNII: 95LLB1K2WE) CHOLESTERYL NONANOATE (UNII: 4313O7P4XW) CHOLESTERYL ISOSTEARATE (UNII: JD5KDN9464) CHOLESTERYL CHLORIDE (UNII: 39EHZ05V39) Product Characteristics Color brown (Medium Tan) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 69259-0429-1 30 mL in 1 TUBE; Type 0: Not a Combination Product 08/23/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/23/2017 BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 NEUTRAL TAN
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 69259-0436 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 9.0 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI) Butyloctyl Salicylate (UNII: 2EH13UN8D3) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Hexyl Laurate (UNII: 4CG9F9W01Q) Stearic Acid (UNII: 4ELV7Z65AP) Calcium Stearate (UNII: 776XM7047L) Caprylyl Glycol (UNII: 00YIU5438U) Triethoxycaprylylsilane (UNII: LDC331P08E) Ethylhexylglycerin (UNII: 147D247K3P) Sorbitan Isostearate (UNII: 01S2G2C1E4) Phenoxyethanol (UNII: HIE492ZZ3T) 1,2-Hexanediol (UNII: TR046Y3K1G) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) LIME OIL (UNII: UZH29XGA8G) GRAPE SEED OIL (UNII: 930MLC8XGG) Punica Granatum Seed Oil (UNII: 0UI45XV0T6) AVOCADO OIL (UNII: 6VNO72PFC1) Niacinamide (UNII: 25X51I8RD4) WHITE PINE OIL (UNII: HA5CX6676U) GRAPEFRUIT OIL (UNII: YR377U58W9) Cholesterol (UNII: 97C5T2UQ7J) Glycerin (UNII: PDC6A3C0OX) EUCALYPTUS OIL (UNII: 2R04ONI662) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SOYBEAN OIL (UNII: 241ATL177A) Pentafluoropropane (UNII: TA9UOF49CY) TURMERIC (UNII: 856YO1Z64F) Steareth-20 (UNII: L0Q8IK9E08) SILK, BASE HYDROLYZED (1000 MW) (UNII: UMQ31C11AY) HYALURONIC ACID (UNII: S270N0TRQY) OATMEAL (UNII: 8PI54V663Y) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Sodium Benzoate (UNII: OJ245FE5EU) Potassium Sorbate (UNII: 1VPU26JZZ4) ALOE VERA LEAF (UNII: ZY81Z83H0X) N-Hydroxysuccinimide (UNII: MJE3791M4T) HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P) Caprylhydroxamic Acid (UNII: UPY805K99W) Tocopherol (UNII: R0ZB2556P8) THIAMINE HYDROCHLORIDE (UNII: M572600E5P) Riboflavin (UNII: TLM2976OFR) RETINOL (UNII: G2SH0XKK91) Pantothenic Acid (UNII: 19F5HK2737) Palmitoyl Oligopeptide (UNII: HO4ZT5S86C) Niacin (UNII: 2679MF687A) Folic Acid (UNII: 935E97BOY8) Chrysin (UNII: 3CN01F5ZJ5) CARNITINE HYDROCHLORIDE, (+)- (UNII: 11X758JML9) Biotin (UNII: 6SO6U10H04) Ascorbic Acid (UNII: PQ6CK8PD0R) Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R) CHLORHEXIDINE (UNII: R4KO0DY52L) BROWN IRON OXIDE (UNII: 1N032N7MFO) CHOLESTERYL OLEYL CARBONATE (UNII: 95LLB1K2WE) CHOLESTERYL NONANOATE (UNII: 4313O7P4XW) CHOLESTERYL ISOSTEARATE (UNII: JD5KDN9464) CHOLESTERYL CHLORIDE (UNII: 39EHZ05V39) Product Characteristics Color brown (Neutral Tan) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 69259-0436-1 30 mL in 1 TUBE; Type 0: Not a Combination Product 08/23/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/23/2017 BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 RICH
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 69259-0443 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 9.0 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI) Butyloctyl Salicylate (UNII: 2EH13UN8D3) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Hexyl Laurate (UNII: 4CG9F9W01Q) Stearic Acid (UNII: 4ELV7Z65AP) Calcium Stearate (UNII: 776XM7047L) Caprylyl Glycol (UNII: 00YIU5438U) Triethoxycaprylylsilane (UNII: LDC331P08E) Ethylhexylglycerin (UNII: 147D247K3P) Sorbitan Isostearate (UNII: 01S2G2C1E4) Phenoxyethanol (UNII: HIE492ZZ3T) 1,2-Hexanediol (UNII: TR046Y3K1G) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) LIME OIL (UNII: UZH29XGA8G) GRAPE SEED OIL (UNII: 930MLC8XGG) Punica Granatum Seed Oil (UNII: 0UI45XV0T6) AVOCADO OIL (UNII: 6VNO72PFC1) Niacinamide (UNII: 25X51I8RD4) WHITE PINE OIL (UNII: HA5CX6676U) GRAPEFRUIT OIL (UNII: YR377U58W9) Cholesterol (UNII: 97C5T2UQ7J) Glycerin (UNII: PDC6A3C0OX) EUCALYPTUS OIL (UNII: 2R04ONI662) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SOYBEAN OIL (UNII: 241ATL177A) Pentafluoropropane (UNII: TA9UOF49CY) TURMERIC (UNII: 856YO1Z64F) Steareth-20 (UNII: L0Q8IK9E08) SILK, BASE HYDROLYZED (1000 MW) (UNII: UMQ31C11AY) HYALURONIC ACID (UNII: S270N0TRQY) OATMEAL (UNII: 8PI54V663Y) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Sodium Benzoate (UNII: OJ245FE5EU) Potassium Sorbate (UNII: 1VPU26JZZ4) ALOE VERA LEAF (UNII: ZY81Z83H0X) N-Hydroxysuccinimide (UNII: MJE3791M4T) HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P) Caprylhydroxamic Acid (UNII: UPY805K99W) Tocopherol (UNII: R0ZB2556P8) THIAMINE HYDROCHLORIDE (UNII: M572600E5P) Riboflavin (UNII: TLM2976OFR) RETINOL (UNII: G2SH0XKK91) Pantothenic Acid (UNII: 19F5HK2737) Palmitoyl Oligopeptide (UNII: HO4ZT5S86C) Niacin (UNII: 2679MF687A) Folic Acid (UNII: 935E97BOY8) Chrysin (UNII: 3CN01F5ZJ5) CARNITINE HYDROCHLORIDE, (+)- (UNII: 11X758JML9) Biotin (UNII: 6SO6U10H04) Ascorbic Acid (UNII: PQ6CK8PD0R) Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R) CHLORHEXIDINE (UNII: R4KO0DY52L) BROWN IRON OXIDE (UNII: 1N032N7MFO) CHOLESTERYL OLEYL CARBONATE (UNII: 95LLB1K2WE) CHOLESTERYL NONANOATE (UNII: 4313O7P4XW) CHOLESTERYL ISOSTEARATE (UNII: JD5KDN9464) CHOLESTERYL CHLORIDE (UNII: 39EHZ05V39) Product Characteristics Color brown (Rich) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 69259-0443-1 30 mL in 1 TUBE; Type 0: Not a Combination Product 08/23/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/23/2017 BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 DEEP
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 69259-0450 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 9.0 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI) Butyloctyl Salicylate (UNII: 2EH13UN8D3) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Hexyl Laurate (UNII: 4CG9F9W01Q) Stearic Acid (UNII: 4ELV7Z65AP) Calcium Stearate (UNII: 776XM7047L) Caprylyl Glycol (UNII: 00YIU5438U) Triethoxycaprylylsilane (UNII: LDC331P08E) Ethylhexylglycerin (UNII: 147D247K3P) Sorbitan Isostearate (UNII: 01S2G2C1E4) Phenoxyethanol (UNII: HIE492ZZ3T) 1,2-Hexanediol (UNII: TR046Y3K1G) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) LIME OIL (UNII: UZH29XGA8G) GRAPE SEED OIL (UNII: 930MLC8XGG) Punica Granatum Seed Oil (UNII: 0UI45XV0T6) AVOCADO OIL (UNII: 6VNO72PFC1) Niacinamide (UNII: 25X51I8RD4) WHITE PINE OIL (UNII: HA5CX6676U) GRAPEFRUIT OIL (UNII: YR377U58W9) Cholesterol (UNII: 97C5T2UQ7J) Glycerin (UNII: PDC6A3C0OX) EUCALYPTUS OIL (UNII: 2R04ONI662) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SOYBEAN OIL (UNII: 241ATL177A) Pentafluoropropane (UNII: TA9UOF49CY) TURMERIC (UNII: 856YO1Z64F) Steareth-20 (UNII: L0Q8IK9E08) SILK, BASE HYDROLYZED (1000 MW) (UNII: UMQ31C11AY) HYALURONIC ACID (UNII: S270N0TRQY) OATMEAL (UNII: 8PI54V663Y) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Sodium Benzoate (UNII: OJ245FE5EU) Potassium Sorbate (UNII: 1VPU26JZZ4) ALOE VERA LEAF (UNII: ZY81Z83H0X) N-Hydroxysuccinimide (UNII: MJE3791M4T) HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P) Caprylhydroxamic Acid (UNII: UPY805K99W) Tocopherol (UNII: R0ZB2556P8) THIAMINE HYDROCHLORIDE (UNII: M572600E5P) Riboflavin (UNII: TLM2976OFR) RETINOL (UNII: G2SH0XKK91) Pantothenic Acid (UNII: 19F5HK2737) Palmitoyl Oligopeptide (UNII: HO4ZT5S86C) Niacin (UNII: 2679MF687A) Folic Acid (UNII: 935E97BOY8) Chrysin (UNII: 3CN01F5ZJ5) CARNITINE HYDROCHLORIDE, (+)- (UNII: 11X758JML9) Biotin (UNII: 6SO6U10H04) Ascorbic Acid (UNII: PQ6CK8PD0R) Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R) CHLORHEXIDINE (UNII: R4KO0DY52L) BROWN IRON OXIDE (UNII: 1N032N7MFO) CHOLESTERYL OLEYL CARBONATE (UNII: 95LLB1K2WE) CHOLESTERYL NONANOATE (UNII: 4313O7P4XW) CHOLESTERYL ISOSTEARATE (UNII: JD5KDN9464) CHOLESTERYL CHLORIDE (UNII: 39EHZ05V39) Product Characteristics Color brown (Deep) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 69259-0450-1 30 mL in 1 TUBE; Type 0: Not a Combination Product 08/23/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/23/2017 BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 NEUTRAL MEDIUM
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 69259-0719 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 9.0 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI) Butyloctyl Salicylate (UNII: 2EH13UN8D3) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Hexyl Laurate (UNII: 4CG9F9W01Q) Stearic Acid (UNII: 4ELV7Z65AP) Calcium Stearate (UNII: 776XM7047L) Caprylyl Glycol (UNII: 00YIU5438U) Triethoxycaprylylsilane (UNII: LDC331P08E) Ethylhexylglycerin (UNII: 147D247K3P) Sorbitan Isostearate (UNII: 01S2G2C1E4) Phenoxyethanol (UNII: HIE492ZZ3T) 1,2-Hexanediol (UNII: TR046Y3K1G) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) LIME OIL (UNII: UZH29XGA8G) GRAPE SEED OIL (UNII: 930MLC8XGG) Punica Granatum Seed Oil (UNII: 0UI45XV0T6) AVOCADO OIL (UNII: 6VNO72PFC1) Niacinamide (UNII: 25X51I8RD4) WHITE PINE OIL (UNII: HA5CX6676U) GRAPEFRUIT OIL (UNII: YR377U58W9) Cholesterol (UNII: 97C5T2UQ7J) Glycerin (UNII: PDC6A3C0OX) EUCALYPTUS OIL (UNII: 2R04ONI662) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SOYBEAN OIL (UNII: 241ATL177A) Pentafluoropropane (UNII: TA9UOF49CY) TURMERIC (UNII: 856YO1Z64F) Steareth-20 (UNII: L0Q8IK9E08) SILK, BASE HYDROLYZED (1000 MW) (UNII: UMQ31C11AY) HYALURONIC ACID (UNII: S270N0TRQY) OATMEAL (UNII: 8PI54V663Y) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Sodium Benzoate (UNII: OJ245FE5EU) Potassium Sorbate (UNII: 1VPU26JZZ4) ALOE VERA LEAF (UNII: ZY81Z83H0X) N-Hydroxysuccinimide (UNII: MJE3791M4T) HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P) Caprylhydroxamic Acid (UNII: UPY805K99W) Tocopherol (UNII: R0ZB2556P8) THIAMINE HYDROCHLORIDE (UNII: M572600E5P) Riboflavin (UNII: TLM2976OFR) RETINOL (UNII: G2SH0XKK91) Pantothenic Acid (UNII: 19F5HK2737) Palmitoyl Oligopeptide (UNII: HO4ZT5S86C) Niacin (UNII: 2679MF687A) Folic Acid (UNII: 935E97BOY8) Chrysin (UNII: 3CN01F5ZJ5) CARNITINE HYDROCHLORIDE, (+)- (UNII: 11X758JML9) Biotin (UNII: 6SO6U10H04) Ascorbic Acid (UNII: PQ6CK8PD0R) Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R) CHLORHEXIDINE (UNII: R4KO0DY52L) BROWN IRON OXIDE (UNII: 1N032N7MFO) CHOLESTERYL OLEYL CARBONATE (UNII: 95LLB1K2WE) CHOLESTERYL NONANOATE (UNII: 4313O7P4XW) CHOLESTERYL ISOSTEARATE (UNII: JD5KDN9464) CHOLESTERYL CHLORIDE (UNII: 39EHZ05V39) Product Characteristics Color brown (Neutral Medium) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 69259-0719-1 30 mL in 1 TUBE; Type 0: Not a Combination Product 08/23/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/23/2017 BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 RICH HONEY
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 69259-0733 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 9.0 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI) Butyloctyl Salicylate (UNII: 2EH13UN8D3) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Hexyl Laurate (UNII: 4CG9F9W01Q) Stearic Acid (UNII: 4ELV7Z65AP) Calcium Stearate (UNII: 776XM7047L) Caprylyl Glycol (UNII: 00YIU5438U) Triethoxycaprylylsilane (UNII: LDC331P08E) Ethylhexylglycerin (UNII: 147D247K3P) Sorbitan Isostearate (UNII: 01S2G2C1E4) Phenoxyethanol (UNII: HIE492ZZ3T) 1,2-Hexanediol (UNII: TR046Y3K1G) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) LIME OIL (UNII: UZH29XGA8G) GRAPE SEED OIL (UNII: 930MLC8XGG) Punica Granatum Seed Oil (UNII: 0UI45XV0T6) AVOCADO OIL (UNII: 6VNO72PFC1) Niacinamide (UNII: 25X51I8RD4) WHITE PINE OIL (UNII: HA5CX6676U) GRAPEFRUIT OIL (UNII: YR377U58W9) Cholesterol (UNII: 97C5T2UQ7J) Glycerin (UNII: PDC6A3C0OX) EUCALYPTUS OIL (UNII: 2R04ONI662) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SOYBEAN OIL (UNII: 241ATL177A) Pentafluoropropane (UNII: TA9UOF49CY) TURMERIC (UNII: 856YO1Z64F) Steareth-20 (UNII: L0Q8IK9E08) SILK, BASE HYDROLYZED (1000 MW) (UNII: UMQ31C11AY) HYALURONIC ACID (UNII: S270N0TRQY) OATMEAL (UNII: 8PI54V663Y) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Sodium Benzoate (UNII: OJ245FE5EU) Potassium Sorbate (UNII: 1VPU26JZZ4) ALOE VERA LEAF (UNII: ZY81Z83H0X) N-Hydroxysuccinimide (UNII: MJE3791M4T) HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P) Caprylhydroxamic Acid (UNII: UPY805K99W) Tocopherol (UNII: R0ZB2556P8) THIAMINE HYDROCHLORIDE (UNII: M572600E5P) Riboflavin (UNII: TLM2976OFR) RETINOL (UNII: G2SH0XKK91) Pantothenic Acid (UNII: 19F5HK2737) Palmitoyl Oligopeptide (UNII: HO4ZT5S86C) Niacin (UNII: 2679MF687A) Folic Acid (UNII: 935E97BOY8) Chrysin (UNII: 3CN01F5ZJ5) CARNITINE HYDROCHLORIDE, (+)- (UNII: 11X758JML9) Biotin (UNII: 6SO6U10H04) Ascorbic Acid (UNII: PQ6CK8PD0R) Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R) CHLORHEXIDINE (UNII: R4KO0DY52L) BROWN IRON OXIDE (UNII: 1N032N7MFO) CHOLESTERYL OLEYL CARBONATE (UNII: 95LLB1K2WE) CHOLESTERYL NONANOATE (UNII: 4313O7P4XW) CHOLESTERYL ISOSTEARATE (UNII: JD5KDN9464) CHOLESTERYL CHLORIDE (UNII: 39EHZ05V39) Product Characteristics Color brown (Rich Honey) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 69259-0733-1 30 mL in 1 TUBE; Type 0: Not a Combination Product 08/23/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/23/2017 BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 FAIR LIGHT
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 69259-1334 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 9.0 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI) Butyloctyl Salicylate (UNII: 2EH13UN8D3) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Hexyl Laurate (UNII: 4CG9F9W01Q) Stearic Acid (UNII: 4ELV7Z65AP) Calcium Stearate (UNII: 776XM7047L) Caprylyl Glycol (UNII: 00YIU5438U) Triethoxycaprylylsilane (UNII: LDC331P08E) Ethylhexylglycerin (UNII: 147D247K3P) Sorbitan Isostearate (UNII: 01S2G2C1E4) Phenoxyethanol (UNII: HIE492ZZ3T) 1,2-Hexanediol (UNII: TR046Y3K1G) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) LIME OIL (UNII: UZH29XGA8G) GRAPE SEED OIL (UNII: 930MLC8XGG) Punica Granatum Seed Oil (UNII: 0UI45XV0T6) AVOCADO OIL (UNII: 6VNO72PFC1) Niacinamide (UNII: 25X51I8RD4) WHITE PINE OIL (UNII: HA5CX6676U) GRAPEFRUIT OIL (UNII: YR377U58W9) Cholesterol (UNII: 97C5T2UQ7J) Glycerin (UNII: PDC6A3C0OX) EUCALYPTUS OIL (UNII: 2R04ONI662) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SOYBEAN OIL (UNII: 241ATL177A) Pentafluoropropane (UNII: TA9UOF49CY) TURMERIC (UNII: 856YO1Z64F) Steareth-20 (UNII: L0Q8IK9E08) SILK, BASE HYDROLYZED (1000 MW) (UNII: UMQ31C11AY) HYALURONIC ACID (UNII: S270N0TRQY) OATMEAL (UNII: 8PI54V663Y) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Sodium Benzoate (UNII: OJ245FE5EU) Potassium Sorbate (UNII: 1VPU26JZZ4) ALOE VERA LEAF (UNII: ZY81Z83H0X) N-Hydroxysuccinimide (UNII: MJE3791M4T) HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P) Caprylhydroxamic Acid (UNII: UPY805K99W) Tocopherol (UNII: R0ZB2556P8) THIAMINE HYDROCHLORIDE (UNII: M572600E5P) Riboflavin (UNII: TLM2976OFR) RETINOL (UNII: G2SH0XKK91) Pantothenic Acid (UNII: 19F5HK2737) Palmitoyl Oligopeptide (UNII: HO4ZT5S86C) Niacin (UNII: 2679MF687A) Folic Acid (UNII: 935E97BOY8) Chrysin (UNII: 3CN01F5ZJ5) CARNITINE HYDROCHLORIDE, (+)- (UNII: 11X758JML9) Biotin (UNII: 6SO6U10H04) Ascorbic Acid (UNII: PQ6CK8PD0R) Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R) CHLORHEXIDINE (UNII: R4KO0DY52L) BROWN IRON OXIDE (UNII: 1N032N7MFO) CHOLESTERYL OLEYL CARBONATE (UNII: 95LLB1K2WE) CHOLESTERYL NONANOATE (UNII: 4313O7P4XW) CHOLESTERYL ISOSTEARATE (UNII: JD5KDN9464) CHOLESTERYL CHLORIDE (UNII: 39EHZ05V39) Product Characteristics Color brown (Fair Light) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 69259-1334-1 30 mL in 1 TUBE; Type 0: Not a Combination Product 08/23/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/23/2017 BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 LIGHT MEDIUM
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 69259-1341 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 9.0 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI) Butyloctyl Salicylate (UNII: 2EH13UN8D3) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Hexyl Laurate (UNII: 4CG9F9W01Q) Stearic Acid (UNII: 4ELV7Z65AP) Calcium Stearate (UNII: 776XM7047L) Caprylyl Glycol (UNII: 00YIU5438U) Triethoxycaprylylsilane (UNII: LDC331P08E) Ethylhexylglycerin (UNII: 147D247K3P) Sorbitan Isostearate (UNII: 01S2G2C1E4) Phenoxyethanol (UNII: HIE492ZZ3T) 1,2-Hexanediol (UNII: TR046Y3K1G) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) LIME OIL (UNII: UZH29XGA8G) GRAPE SEED OIL (UNII: 930MLC8XGG) Punica Granatum Seed Oil (UNII: 0UI45XV0T6) AVOCADO OIL (UNII: 6VNO72PFC1) Niacinamide (UNII: 25X51I8RD4) WHITE PINE OIL (UNII: HA5CX6676U) GRAPEFRUIT OIL (UNII: YR377U58W9) Cholesterol (UNII: 97C5T2UQ7J) Glycerin (UNII: PDC6A3C0OX) EUCALYPTUS OIL (UNII: 2R04ONI662) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SOYBEAN OIL (UNII: 241ATL177A) Pentafluoropropane (UNII: TA9UOF49CY) TURMERIC (UNII: 856YO1Z64F) Steareth-20 (UNII: L0Q8IK9E08) SILK, BASE HYDROLYZED (1000 MW) (UNII: UMQ31C11AY) HYALURONIC ACID (UNII: S270N0TRQY) OATMEAL (UNII: 8PI54V663Y) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Sodium Benzoate (UNII: OJ245FE5EU) Potassium Sorbate (UNII: 1VPU26JZZ4) ALOE VERA LEAF (UNII: ZY81Z83H0X) N-Hydroxysuccinimide (UNII: MJE3791M4T) HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P) Caprylhydroxamic Acid (UNII: UPY805K99W) Tocopherol (UNII: R0ZB2556P8) THIAMINE HYDROCHLORIDE (UNII: M572600E5P) Riboflavin (UNII: TLM2976OFR) RETINOL (UNII: G2SH0XKK91) Pantothenic Acid (UNII: 19F5HK2737) Palmitoyl Oligopeptide (UNII: HO4ZT5S86C) Niacin (UNII: 2679MF687A) Folic Acid (UNII: 935E97BOY8) Chrysin (UNII: 3CN01F5ZJ5) CARNITINE HYDROCHLORIDE, (+)- (UNII: 11X758JML9) Biotin (UNII: 6SO6U10H04) Ascorbic Acid (UNII: PQ6CK8PD0R) Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R) CHLORHEXIDINE (UNII: R4KO0DY52L) BROWN IRON OXIDE (UNII: 1N032N7MFO) CHOLESTERYL OLEYL CARBONATE (UNII: 95LLB1K2WE) CHOLESTERYL NONANOATE (UNII: 4313O7P4XW) CHOLESTERYL ISOSTEARATE (UNII: JD5KDN9464) CHOLESTERYL CHLORIDE (UNII: 39EHZ05V39) Product Characteristics Color brown (Light Medium) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 69259-1341-1 30 mL in 1 TUBE; Type 0: Not a Combination Product 08/23/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/23/2017 BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER SPF 50 TAN
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 69259-1358 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 9.0 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI) Butyloctyl Salicylate (UNII: 2EH13UN8D3) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Hexyl Laurate (UNII: 4CG9F9W01Q) Stearic Acid (UNII: 4ELV7Z65AP) Calcium Stearate (UNII: 776XM7047L) Caprylyl Glycol (UNII: 00YIU5438U) Triethoxycaprylylsilane (UNII: LDC331P08E) Ethylhexylglycerin (UNII: 147D247K3P) Sorbitan Isostearate (UNII: 01S2G2C1E4) Phenoxyethanol (UNII: HIE492ZZ3T) 1,2-Hexanediol (UNII: TR046Y3K1G) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) LIME OIL (UNII: UZH29XGA8G) GRAPE SEED OIL (UNII: 930MLC8XGG) Punica Granatum Seed Oil (UNII: 0UI45XV0T6) AVOCADO OIL (UNII: 6VNO72PFC1) Niacinamide (UNII: 25X51I8RD4) WHITE PINE OIL (UNII: HA5CX6676U) GRAPEFRUIT OIL (UNII: YR377U58W9) Cholesterol (UNII: 97C5T2UQ7J) Glycerin (UNII: PDC6A3C0OX) EUCALYPTUS OIL (UNII: 2R04ONI662) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SOYBEAN OIL (UNII: 241ATL177A) Pentafluoropropane (UNII: TA9UOF49CY) TURMERIC (UNII: 856YO1Z64F) Steareth-20 (UNII: L0Q8IK9E08) SILK, BASE HYDROLYZED (1000 MW) (UNII: UMQ31C11AY) HYALURONIC ACID (UNII: S270N0TRQY) OATMEAL (UNII: 8PI54V663Y) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Sodium Benzoate (UNII: OJ245FE5EU) Potassium Sorbate (UNII: 1VPU26JZZ4) ALOE VERA LEAF (UNII: ZY81Z83H0X) N-Hydroxysuccinimide (UNII: MJE3791M4T) HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P) Caprylhydroxamic Acid (UNII: UPY805K99W) Tocopherol (UNII: R0ZB2556P8) THIAMINE HYDROCHLORIDE (UNII: M572600E5P) Riboflavin (UNII: TLM2976OFR) RETINOL (UNII: G2SH0XKK91) Pantothenic Acid (UNII: 19F5HK2737) Palmitoyl Oligopeptide (UNII: HO4ZT5S86C) Niacin (UNII: 2679MF687A) Folic Acid (UNII: 935E97BOY8) Chrysin (UNII: 3CN01F5ZJ5) CARNITINE HYDROCHLORIDE, (+)- (UNII: 11X758JML9) Biotin (UNII: 6SO6U10H04) Ascorbic Acid (UNII: PQ6CK8PD0R) Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R) CHLORHEXIDINE (UNII: R4KO0DY52L) BROWN IRON OXIDE (UNII: 1N032N7MFO) CHOLESTERYL OLEYL CARBONATE (UNII: 95LLB1K2WE) CHOLESTERYL NONANOATE (UNII: 4313O7P4XW) CHOLESTERYL ISOSTEARATE (UNII: JD5KDN9464) CHOLESTERYL CHLORIDE (UNII: 39EHZ05V39) Product Characteristics Color brown (Tan) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 69259-1358-1 30 mL in 1 TUBE; Type 0: Not a Combination Product 08/23/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/23/2017 Labeler - IT COSMETICS, LLC (962591793)
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