Label: IT COSMETICS BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL FREE MATTE BROAD SPECTRUM 50 PLUS SUNSCREEN- titanium dioxide and zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 30, 2023

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

  • Active ingredients

    Titanium dioxide 7.4%

    Zinc oxide  6.3%

  • Purpose

    Sunscreen

  • Uses

    - 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 a Poison Control Center right away.

  • Directions

    ● shake well before use

    ● 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 information

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

  • Inactive ingredients

    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 or comments?

    Call 800-620-3956

  • PRINCIPAL DISPLAY PANEL

    image of a cartonimage of a carton

    image of a carton
  • INGREDIENTS AND APPEARANCE
    IT COSMETICS BYE BYE FOUNDATION FULL COVERAGE MOISTURIZER OIL FREE MATTE BROAD SPECTRUM 50 PLUS SUNSCREEN 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69259-4244
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE74 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE63 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    ETHOHEXADIOL (UNII: M9JGK7U88V)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    OAT (UNII: Z6J799EAJK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    TURMERIC (UNII: 856YO1Z64F)  
    SULFUR (UNII: 70FD1KFU70)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    PERFLEXANE (UNII: FX3WJ41CMX)  
    AVOCADO (UNII: SDS87L369F)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    MAGNOLIA KOBUS BARK (UNII: 54LVP49595)  
    CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    PERFLUNAFENE (UNII: 54A06VV62N)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PERFLUOROMETHYLCYCLOPENTANE (UNII: 8S014W4T75)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    CHINESE CINNAMON (UNII: WS4CQ062KM)  
    PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)  
    DIOSPYROS KAKI LEAF (UNII: Q71GF9OBNO)  
    WHITE MULBERRY (UNII: MN25R0HH5A)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)  
    POMEGRANATE JUICE (UNII: 99S671U9KB)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    CHRYSIN (UNII: 3CN01F5ZJ5)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    BIOTIN (UNII: 6SO6U10H04)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69259-4244-11 in 1 CARTON06/01/2019
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2019
    Labeler - IT COSMETICS, LLC (962591793)
    Establishment
    NameAddressID/FEIBusiness Operations
    Beauty Manufacturing Solutions Corp.783200723manufacture(69259-4244)