Label: MD MINERAL BB CREME BROAD SPECTRUM SPF 50 WATER RESISTANT 80 MIN- titanium dioxide, zinc oxide cream

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

Drug Label Information

Updated December 12, 2023

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

  • Drug Facts

  • Active ingredients

    Titanium Dioxide 2%.

    Zinc Oxide 17%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

  • Warnings

    For external use only

    Do not use

    on damaged or broken skin

    Stop use and ask a doctor

    if rash occurs

    When using this product

    keep out of eyes. Rinse with water to remove.

    Keep out of reach of children.

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

  • Directions

    • Apply liberally 15 minutes before sun exposure • : • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • Children under 6 months: Ask a doctor • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10a.m. - 2p.m. • Wear long-sleeved shirts, pants, hats and sunglasses


    ReapplySun Protection Measures:

  • Other Information

    •Protect the product in this container from excessive heat and direct sunlight • May stain some fabrics • You may report serious adverse reactions to: Report Reaction, LLC., PO Box 22, Plainsboro, NJ 08536-0222 Shake well. Rub in well.

  • Inactive Ingredients

    Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone/ Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Glyceryl Isostearate, Polysilicone-15, Niacinamide, Caffeine, Ubiquinone (CoQ10), Tetrahexyldecyl Ascorbate (Vitamin C), Squalane, Punica Granatum Extract (Pomegranate), Vaccinium Macrocarpon (Cranberry) Fruit Extract, Camellia Sinensis Leaf Extract (Green Tea), Silica, Polyhydroxystearic Acid, Triethoxycaprylylsilane, May Contain: (CI 77891, CI 77491, CI 77492, CI 77499)

  • Package Labeling:

    Outer Package2Inner Package2

  • INGREDIENTS AND APPEARANCE
    MD MINERAL BB CREME BROAD SPECTRUM SPF 50 WATER RESISTANT 80 MIN 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14268-126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE20 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION170 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CAFFEINE (UNII: 3G6A5W338E)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    SQUALANE (UNII: GW89575KF9)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14268-126-0135 g in 1 TUBE; Type 0: Not a Combination Product04/19/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/19/2023
    Labeler - ENGLEWOOD LAB, INC. (172198223)
    Establishment
    NameAddressID/FEIBusiness Operations
    ENGLEWOOD LAB, INC.172198223manufacture(14268-126) , label(14268-126)