Label: ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER NEUTRAL MEDIUM- titanium dioxide, zinc oxide cream
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER MEDIUM TAN- titanium dioxide, zinc oxide cream
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER LIGHT MEDIUM- titanium dioxide, zinc oxide cream
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER RICH HONEY- titanium dioxide, zinc oxide cream
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER MEDIUM- titanium dioxide, zinc oxide cream
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER TAN- titanium dioxide, zinc oxide cream
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER FAIR- titanium dioxide, zinc oxide cream
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER RICH- titanium dioxide, zinc oxide cream
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER NEUTRAL TAN- titanium dioxide, zinc oxide cream
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER DEEP- titanium dioxide, zinc oxide cream
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER FAIR LIGHT- titanium dioxide, zinc oxide cream
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER LIGHT- titanium dioxide, zinc oxide cream
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NDC Code(s):
11090-114-01,
11090-114-02,
11090-115-01,
11090-115-02, view more11090-116-01, 11090-116-02, 11090-117-01, 11090-117-02, 11090-118-01, 11090-118-02, 11090-119-01, 11090-119-02, 11090-120-01, 11090-120-02, 11090-121-01, 11090-121-02, 11090-122-01, 11090-122-02, 11090-123-01, 11090-123-02, 11090-124-01, 11090-124-02, 11090-125-01, 11090-125-02
- 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 17, 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
- INSTRUCTIONS FOR USE
- WARNINGS
- 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, phenyl trimethicone, dimethicone, butylene glycol, butylene glycol dicaprylate/dicaprate, orbignya oleifera seed oil, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethicone, cyclopentasiloxane, snail secretion filtrate, aluminum hydroxide, magnesium sulfate, polyglyceryl-4 isostearate,, stearic acid,, cyclohexasiloxane, dimethicone/vinyl dimethicone crosspolymer, hexyl laurate, calcium stearate, caprylyl glycol, triethoxycaprylylsilane, ethyl hexanediol, ethylhexylglycerin, limonene, phenoxyethanol, citrus limon (lemon) peel oil, sorbitan isostearate, tocopheryl acetate, 1,2-hexanediol, citrus aurantium bergamia (bergamot) fruit oil, disodium EDTA, citrus aurantium dulcis (orange) peel oil, citrus aurantifolia (lime) oil, pinus sylvestris leaf oil, niacinamide, punica granatum seed oil, vitis vinifera (grape) seed oil, cholesterol, cholesteryl oleyl carbonate, persea gratissima (avocado) oil, polymethylsilsesquioxane, anthemis nobilis flower water, lactobacillus/dipteryx odorata seed ferment filtrate, lactobacillus/pumpkin ferment extract, linalool, panax ginseng root extract, avena sativa (oat) kernel extract, eucalyptus globulus leaf oil, saccharomyces/rice ferment filtrate, lactobacillus/kelp ferment filtrate, cholesteryl isostearate, citral, cholesteryl chloride, cholesteryl nonanoate, curcuma longa (turmeric) root extract, perfluorohexane, glycerin, leuconostoc/radish root ferment filtrate, magnolia kobus bark extract, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, camellia sinensis leaf extract, glycine soja (soybean) sprout extract, perfluorodecalin, silk extract, hydrolyzed silk, perfluoromethylcyclopentane, silica, steareth-20, citric acid, saccharum officinarum (sugarcane) extract, cocos nucifera (coconut) fruit extract, hydrolyzed collagen, saccharomyces/camellia sinensis extract ferment filtrate, bacillus/cordyceps sinensis/ganoderma lucidum/inonotus obliquus/lentinus edodes/phellinus linteus/schizophyllum commune/tricholoma matsutake extract ferment filtrate, phaseolus angularis seed extract, lactobacillus ferment, lactobacillus/centella asiatica/gleditsia sinensis thorn/houttuynia cordata extract/phellodendron amurense bark/polygonum cuspidatum root/prunella vulgaris/torilis japonica extract ferment filtrate, lactobacillus/rice ferment filtrate, sodium benzoate, chrysanthemum indicum flower extract, potassium sorbate, BHT, diamond powder, lactobacillus/honeysuckle flower/licorice root/morus alba root/pueraria lobata root/schisandra chinensis fruit/scutellaria baicalensis root/sophora japonica flower extract ferment filtrate, aloe barbadensis leaf extract, caprylhydroxamic 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, chlorhexidine digluconate, n-hydroxysuccinimide, biotin, thiamine HCL, niacin, folic acid, retinyl palmitate, carnitine HCL, riboflavin, tocopherol, ascorbic acid, pantothenic acid, sodium citrate, palmitoyl tripeptide-1, hydrolyzed hyaluronic acid, chrysin, palmitoyl tetrapeptide-7; may contain: titanium dioxide, iron oxides
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER NEUTRAL MEDIUM
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-119 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 63 mg in 1 mL Inactive Ingredients Ingredient Name Strength ADENOSINE (UNII: K72T3FS567) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) LIME OIL (UNII: UZH29XGA8G) EUCALYPTUS OIL (UNII: 2R04ONI662) WATER (UNII: 059QF0KO0R) FERRIC OXIDE RED (UNII: 1K09F3G675) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HEXYL LAURATE (UNII: 4CG9F9W01Q) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BABASSU OIL (UNII: 8QSB4M5477) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) BERGAMOT OIL (UNII: 39W1PKE3JI) CHRYSIN (UNII: 3CN01F5ZJ5) COCONUT (UNII: 3RT3536DHY) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIAMOND (UNII: 6GRV67N0U2) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PHENOXYETHANOL (UNII: HIE492ZZ3T) LEMON OIL (UNII: I9GRO824LL) CYCLOMETHICONE 6 (UNII: XHK3U310BA) EDETATE DISODIUM (UNII: 7FLD91C86K) ORANGE OIL (UNII: AKN3KSD11B) ASIAN GINSENG (UNII: CUQ3A77YXI) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) STEARETH-20 (UNII: L0Q8IK9E08) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) XANTHAN GUM (UNII: TTV12P4NEE) NIACINAMIDE (UNII: 25X51I8RD4) ADZUKI BEAN (UNII: 31GYU1X0FP) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) HYALURONIC ACID (UNII: S270N0TRQY) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CALCIUM STEARATE (UNII: 776XM7047L) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DIMETHICONE (UNII: 92RU3N3Y1O) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11090-119-01 1 in 1 CARTON 11/01/2020 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11090-119-02 1 in 1 CARTON 11/01/2020 2 75 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 11/01/2020 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER MEDIUM TAN
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 63 mg in 1 mL Inactive Ingredients Ingredient Name Strength ADENOSINE (UNII: K72T3FS567) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) LIME OIL (UNII: UZH29XGA8G) EUCALYPTUS OIL (UNII: 2R04ONI662) WATER (UNII: 059QF0KO0R) FERRIC OXIDE RED (UNII: 1K09F3G675) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HEXYL LAURATE (UNII: 4CG9F9W01Q) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BABASSU OIL (UNII: 8QSB4M5477) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) BERGAMOT OIL (UNII: 39W1PKE3JI) CHRYSIN (UNII: 3CN01F5ZJ5) COCONUT (UNII: 3RT3536DHY) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIAMOND (UNII: 6GRV67N0U2) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PHENOXYETHANOL (UNII: HIE492ZZ3T) LEMON OIL (UNII: I9GRO824LL) CYCLOMETHICONE 6 (UNII: XHK3U310BA) EDETATE DISODIUM (UNII: 7FLD91C86K) ORANGE OIL (UNII: AKN3KSD11B) ASIAN GINSENG (UNII: CUQ3A77YXI) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) STEARETH-20 (UNII: L0Q8IK9E08) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) XANTHAN GUM (UNII: TTV12P4NEE) NIACINAMIDE (UNII: 25X51I8RD4) ADZUKI BEAN (UNII: 31GYU1X0FP) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) HYALURONIC ACID (UNII: S270N0TRQY) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CALCIUM STEARATE (UNII: 776XM7047L) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DIMETHICONE (UNII: 92RU3N3Y1O) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11090-120-01 1 in 1 CARTON 11/01/2020 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11090-120-02 1 in 1 CARTON 11/01/2020 2 75 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 11/01/2020 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER LIGHT MEDIUM
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-117 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 63 mg in 1 mL Inactive Ingredients Ingredient Name Strength ADENOSINE (UNII: K72T3FS567) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) LIME OIL (UNII: UZH29XGA8G) EUCALYPTUS OIL (UNII: 2R04ONI662) WATER (UNII: 059QF0KO0R) FERRIC OXIDE RED (UNII: 1K09F3G675) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HEXYL LAURATE (UNII: 4CG9F9W01Q) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BABASSU OIL (UNII: 8QSB4M5477) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) BERGAMOT OIL (UNII: 39W1PKE3JI) CHRYSIN (UNII: 3CN01F5ZJ5) COCONUT (UNII: 3RT3536DHY) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIAMOND (UNII: 6GRV67N0U2) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PHENOXYETHANOL (UNII: HIE492ZZ3T) LEMON OIL (UNII: I9GRO824LL) CYCLOMETHICONE 6 (UNII: XHK3U310BA) EDETATE DISODIUM (UNII: 7FLD91C86K) ORANGE OIL (UNII: AKN3KSD11B) ASIAN GINSENG (UNII: CUQ3A77YXI) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) STEARETH-20 (UNII: L0Q8IK9E08) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) XANTHAN GUM (UNII: TTV12P4NEE) NIACINAMIDE (UNII: 25X51I8RD4) ADZUKI BEAN (UNII: 31GYU1X0FP) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) HYALURONIC ACID (UNII: S270N0TRQY) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CALCIUM STEARATE (UNII: 776XM7047L) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DIMETHICONE (UNII: 92RU3N3Y1O) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11090-117-01 1 in 1 CARTON 11/01/2020 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11090-117-02 1 in 1 CARTON 11/01/2020 2 75 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 11/01/2020 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER RICH HONEY
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 63 mg in 1 mL Inactive Ingredients Ingredient Name Strength ADENOSINE (UNII: K72T3FS567) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) LIME OIL (UNII: UZH29XGA8G) EUCALYPTUS OIL (UNII: 2R04ONI662) WATER (UNII: 059QF0KO0R) FERRIC OXIDE RED (UNII: 1K09F3G675) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HEXYL LAURATE (UNII: 4CG9F9W01Q) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BABASSU OIL (UNII: 8QSB4M5477) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) BERGAMOT OIL (UNII: 39W1PKE3JI) CHRYSIN (UNII: 3CN01F5ZJ5) COCONUT (UNII: 3RT3536DHY) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIAMOND (UNII: 6GRV67N0U2) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PHENOXYETHANOL (UNII: HIE492ZZ3T) LEMON OIL (UNII: I9GRO824LL) CYCLOMETHICONE 6 (UNII: XHK3U310BA) EDETATE DISODIUM (UNII: 7FLD91C86K) ORANGE OIL (UNII: AKN3KSD11B) ASIAN GINSENG (UNII: CUQ3A77YXI) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) STEARETH-20 (UNII: L0Q8IK9E08) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) XANTHAN GUM (UNII: TTV12P4NEE) NIACINAMIDE (UNII: 25X51I8RD4) ADZUKI BEAN (UNII: 31GYU1X0FP) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) HYALURONIC ACID (UNII: S270N0TRQY) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CALCIUM STEARATE (UNII: 776XM7047L) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DIMETHICONE (UNII: 92RU3N3Y1O) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11090-124-01 1 in 1 CARTON 11/01/2020 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11090-124-02 1 in 1 CARTON 11/01/2020 2 75 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 11/01/2020 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER MEDIUM
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-118 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 63 mg in 1 mL Inactive Ingredients Ingredient Name Strength ADENOSINE (UNII: K72T3FS567) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) LIME OIL (UNII: UZH29XGA8G) EUCALYPTUS OIL (UNII: 2R04ONI662) WATER (UNII: 059QF0KO0R) FERRIC OXIDE RED (UNII: 1K09F3G675) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HEXYL LAURATE (UNII: 4CG9F9W01Q) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BABASSU OIL (UNII: 8QSB4M5477) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) BERGAMOT OIL (UNII: 39W1PKE3JI) CHRYSIN (UNII: 3CN01F5ZJ5) COCONUT (UNII: 3RT3536DHY) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIAMOND (UNII: 6GRV67N0U2) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PHENOXYETHANOL (UNII: HIE492ZZ3T) LEMON OIL (UNII: I9GRO824LL) CYCLOMETHICONE 6 (UNII: XHK3U310BA) EDETATE DISODIUM (UNII: 7FLD91C86K) ORANGE OIL (UNII: AKN3KSD11B) ASIAN GINSENG (UNII: CUQ3A77YXI) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) STEARETH-20 (UNII: L0Q8IK9E08) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) XANTHAN GUM (UNII: TTV12P4NEE) NIACINAMIDE (UNII: 25X51I8RD4) ADZUKI BEAN (UNII: 31GYU1X0FP) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) HYALURONIC ACID (UNII: S270N0TRQY) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CALCIUM STEARATE (UNII: 776XM7047L) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DIMETHICONE (UNII: 92RU3N3Y1O) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11090-118-01 1 in 1 CARTON 11/01/2020 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11090-118-02 1 in 1 CARTON 11/01/2020 2 75 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 11/01/2020 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER TAN
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-122 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 63 mg in 1 mL Inactive Ingredients Ingredient Name Strength ADENOSINE (UNII: K72T3FS567) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) LIME OIL (UNII: UZH29XGA8G) EUCALYPTUS OIL (UNII: 2R04ONI662) WATER (UNII: 059QF0KO0R) FERRIC OXIDE RED (UNII: 1K09F3G675) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HEXYL LAURATE (UNII: 4CG9F9W01Q) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BABASSU OIL (UNII: 8QSB4M5477) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) BERGAMOT OIL (UNII: 39W1PKE3JI) CHRYSIN (UNII: 3CN01F5ZJ5) COCONUT (UNII: 3RT3536DHY) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIAMOND (UNII: 6GRV67N0U2) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PHENOXYETHANOL (UNII: HIE492ZZ3T) LEMON OIL (UNII: I9GRO824LL) CYCLOMETHICONE 6 (UNII: XHK3U310BA) EDETATE DISODIUM (UNII: 7FLD91C86K) ORANGE OIL (UNII: AKN3KSD11B) ASIAN GINSENG (UNII: CUQ3A77YXI) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) STEARETH-20 (UNII: L0Q8IK9E08) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) XANTHAN GUM (UNII: TTV12P4NEE) NIACINAMIDE (UNII: 25X51I8RD4) ADZUKI BEAN (UNII: 31GYU1X0FP) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) HYALURONIC ACID (UNII: S270N0TRQY) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CALCIUM STEARATE (UNII: 776XM7047L) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DIMETHICONE (UNII: 92RU3N3Y1O) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11090-122-01 1 in 1 CARTON 11/01/2020 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11090-122-02 1 in 1 CARTON 11/01/2020 2 75 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 11/01/2020 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER FAIR
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-114 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 63 mg in 1 mL Inactive Ingredients Ingredient Name Strength ADENOSINE (UNII: K72T3FS567) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) LIME OIL (UNII: UZH29XGA8G) EUCALYPTUS OIL (UNII: 2R04ONI662) WATER (UNII: 059QF0KO0R) FERRIC OXIDE RED (UNII: 1K09F3G675) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HEXYL LAURATE (UNII: 4CG9F9W01Q) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BABASSU OIL (UNII: 8QSB4M5477) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) BERGAMOT OIL (UNII: 39W1PKE3JI) CHRYSIN (UNII: 3CN01F5ZJ5) COCONUT (UNII: 3RT3536DHY) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIAMOND (UNII: 6GRV67N0U2) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PHENOXYETHANOL (UNII: HIE492ZZ3T) LEMON OIL (UNII: I9GRO824LL) CYCLOMETHICONE 6 (UNII: XHK3U310BA) EDETATE DISODIUM (UNII: 7FLD91C86K) ORANGE OIL (UNII: AKN3KSD11B) ASIAN GINSENG (UNII: CUQ3A77YXI) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) STEARETH-20 (UNII: L0Q8IK9E08) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) XANTHAN GUM (UNII: TTV12P4NEE) NIACINAMIDE (UNII: 25X51I8RD4) ADZUKI BEAN (UNII: 31GYU1X0FP) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) HYALURONIC ACID (UNII: S270N0TRQY) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CALCIUM STEARATE (UNII: 776XM7047L) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DIMETHICONE (UNII: 92RU3N3Y1O) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11090-114-01 1 in 1 CARTON 11/01/2020 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11090-114-02 1 in 1 CARTON 11/01/2020 2 75 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 11/01/2020 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER RICH
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 63 mg in 1 mL Inactive Ingredients Ingredient Name Strength ADENOSINE (UNII: K72T3FS567) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) LIME OIL (UNII: UZH29XGA8G) EUCALYPTUS OIL (UNII: 2R04ONI662) WATER (UNII: 059QF0KO0R) FERRIC OXIDE RED (UNII: 1K09F3G675) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HEXYL LAURATE (UNII: 4CG9F9W01Q) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BABASSU OIL (UNII: 8QSB4M5477) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) BERGAMOT OIL (UNII: 39W1PKE3JI) CHRYSIN (UNII: 3CN01F5ZJ5) COCONUT (UNII: 3RT3536DHY) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIAMOND (UNII: 6GRV67N0U2) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PHENOXYETHANOL (UNII: HIE492ZZ3T) LEMON OIL (UNII: I9GRO824LL) CYCLOMETHICONE 6 (UNII: XHK3U310BA) EDETATE DISODIUM (UNII: 7FLD91C86K) ORANGE OIL (UNII: AKN3KSD11B) ASIAN GINSENG (UNII: CUQ3A77YXI) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) STEARETH-20 (UNII: L0Q8IK9E08) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) XANTHAN GUM (UNII: TTV12P4NEE) NIACINAMIDE (UNII: 25X51I8RD4) ADZUKI BEAN (UNII: 31GYU1X0FP) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) HYALURONIC ACID (UNII: S270N0TRQY) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CALCIUM STEARATE (UNII: 776XM7047L) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DIMETHICONE (UNII: 92RU3N3Y1O) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11090-123-01 1 in 1 CARTON 11/01/2020 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11090-123-02 1 in 1 CARTON 11/01/2020 2 75 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 11/01/2020 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER NEUTRAL TAN
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 63 mg in 1 mL Inactive Ingredients Ingredient Name Strength ADENOSINE (UNII: K72T3FS567) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) LIME OIL (UNII: UZH29XGA8G) EUCALYPTUS OIL (UNII: 2R04ONI662) WATER (UNII: 059QF0KO0R) FERRIC OXIDE RED (UNII: 1K09F3G675) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HEXYL LAURATE (UNII: 4CG9F9W01Q) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BABASSU OIL (UNII: 8QSB4M5477) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) BERGAMOT OIL (UNII: 39W1PKE3JI) CHRYSIN (UNII: 3CN01F5ZJ5) COCONUT (UNII: 3RT3536DHY) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIAMOND (UNII: 6GRV67N0U2) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PHENOXYETHANOL (UNII: HIE492ZZ3T) LEMON OIL (UNII: I9GRO824LL) CYCLOMETHICONE 6 (UNII: XHK3U310BA) EDETATE DISODIUM (UNII: 7FLD91C86K) ORANGE OIL (UNII: AKN3KSD11B) ASIAN GINSENG (UNII: CUQ3A77YXI) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) STEARETH-20 (UNII: L0Q8IK9E08) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) XANTHAN GUM (UNII: TTV12P4NEE) NIACINAMIDE (UNII: 25X51I8RD4) ADZUKI BEAN (UNII: 31GYU1X0FP) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) HYALURONIC ACID (UNII: S270N0TRQY) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CALCIUM STEARATE (UNII: 776XM7047L) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DIMETHICONE (UNII: 92RU3N3Y1O) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11090-121-01 1 in 1 CARTON 11/01/2020 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11090-121-02 1 in 1 CARTON 11/01/2020 2 75 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 11/01/2020 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER DEEP
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-125 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 63 mg in 1 mL Inactive Ingredients Ingredient Name Strength ADENOSINE (UNII: K72T3FS567) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) LIME OIL (UNII: UZH29XGA8G) EUCALYPTUS OIL (UNII: 2R04ONI662) WATER (UNII: 059QF0KO0R) FERRIC OXIDE RED (UNII: 1K09F3G675) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HEXYL LAURATE (UNII: 4CG9F9W01Q) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BABASSU OIL (UNII: 8QSB4M5477) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) BERGAMOT OIL (UNII: 39W1PKE3JI) CHRYSIN (UNII: 3CN01F5ZJ5) COCONUT (UNII: 3RT3536DHY) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIAMOND (UNII: 6GRV67N0U2) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PHENOXYETHANOL (UNII: HIE492ZZ3T) LEMON OIL (UNII: I9GRO824LL) CYCLOMETHICONE 6 (UNII: XHK3U310BA) EDETATE DISODIUM (UNII: 7FLD91C86K) ORANGE OIL (UNII: AKN3KSD11B) ASIAN GINSENG (UNII: CUQ3A77YXI) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) STEARETH-20 (UNII: L0Q8IK9E08) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) XANTHAN GUM (UNII: TTV12P4NEE) NIACINAMIDE (UNII: 25X51I8RD4) ADZUKI BEAN (UNII: 31GYU1X0FP) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) HYALURONIC ACID (UNII: S270N0TRQY) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CALCIUM STEARATE (UNII: 776XM7047L) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DIMETHICONE (UNII: 92RU3N3Y1O) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11090-125-01 1 in 1 CARTON 11/01/2020 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11090-125-02 1 in 1 CARTON 11/01/2020 2 75 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 11/01/2020 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER FAIR LIGHT
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-115 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 63 mg in 1 mL Inactive Ingredients Ingredient Name Strength ADENOSINE (UNII: K72T3FS567) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) LIME OIL (UNII: UZH29XGA8G) EUCALYPTUS OIL (UNII: 2R04ONI662) WATER (UNII: 059QF0KO0R) FERRIC OXIDE RED (UNII: 1K09F3G675) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HEXYL LAURATE (UNII: 4CG9F9W01Q) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BABASSU OIL (UNII: 8QSB4M5477) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) BERGAMOT OIL (UNII: 39W1PKE3JI) CHRYSIN (UNII: 3CN01F5ZJ5) COCONUT (UNII: 3RT3536DHY) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIAMOND (UNII: 6GRV67N0U2) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PHENOXYETHANOL (UNII: HIE492ZZ3T) LEMON OIL (UNII: I9GRO824LL) CYCLOMETHICONE 6 (UNII: XHK3U310BA) EDETATE DISODIUM (UNII: 7FLD91C86K) ORANGE OIL (UNII: AKN3KSD11B) ASIAN GINSENG (UNII: CUQ3A77YXI) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) STEARETH-20 (UNII: L0Q8IK9E08) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) XANTHAN GUM (UNII: TTV12P4NEE) NIACINAMIDE (UNII: 25X51I8RD4) ADZUKI BEAN (UNII: 31GYU1X0FP) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) HYALURONIC ACID (UNII: S270N0TRQY) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CALCIUM STEARATE (UNII: 776XM7047L) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DIMETHICONE (UNII: 92RU3N3Y1O) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11090-115-01 1 in 1 CARTON 11/01/2020 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11090-115-02 1 in 1 CARTON 11/01/2020 2 75 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 11/01/2020 ITC BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER LIGHT
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-116 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 63 mg in 1 mL Inactive Ingredients Ingredient Name Strength ADENOSINE (UNII: K72T3FS567) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) LIME OIL (UNII: UZH29XGA8G) EUCALYPTUS OIL (UNII: 2R04ONI662) WATER (UNII: 059QF0KO0R) FERRIC OXIDE RED (UNII: 1K09F3G675) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HEXYL LAURATE (UNII: 4CG9F9W01Q) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BABASSU OIL (UNII: 8QSB4M5477) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) BERGAMOT OIL (UNII: 39W1PKE3JI) CHRYSIN (UNII: 3CN01F5ZJ5) COCONUT (UNII: 3RT3536DHY) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIAMOND (UNII: 6GRV67N0U2) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PHENOXYETHANOL (UNII: HIE492ZZ3T) LEMON OIL (UNII: I9GRO824LL) CYCLOMETHICONE 6 (UNII: XHK3U310BA) EDETATE DISODIUM (UNII: 7FLD91C86K) ORANGE OIL (UNII: AKN3KSD11B) ASIAN GINSENG (UNII: CUQ3A77YXI) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) STEARETH-20 (UNII: L0Q8IK9E08) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) XANTHAN GUM (UNII: TTV12P4NEE) NIACINAMIDE (UNII: 25X51I8RD4) ADZUKI BEAN (UNII: 31GYU1X0FP) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) HYALURONIC ACID (UNII: S270N0TRQY) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CALCIUM STEARATE (UNII: 776XM7047L) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DIMETHICONE (UNII: 92RU3N3Y1O) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11090-116-01 1 in 1 CARTON 11/01/2020 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11090-116-02 1 in 1 CARTON 11/01/2020 2 75 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 11/01/2020 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(11090-114, 11090-115, 11090-116, 11090-117, 11090-118, 11090-119, 11090-120, 11090-121, 11090-122, 11090-123, 11090-124, 11090-125)
