Label: MINERAL KIDCREME SPF 50- titanium dioxide and zinc oxide cream

  • 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 September 21, 2023

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Titanium Dioxide 2%Sunscreen
    Zinc Oxide 17%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

    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
    • Reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
      • Children under 6 months: Ask a doctor
    • Sun Protection Measures: 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
  • Other Information

    Shake well. Rub in well.

    • 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
  • Inactive Ingredients

    Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone/ Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Glyceryl Isostearate, Polysilicone-15, Punica Granatum Extract (Pomegranate), Vaccinium Macrocarpon (Cranberry) Fruit Extract, Ubiquinone (CoQ10), Camellia Sinensis Leaf Extract (Green Tea), Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Squalane, Polyhydroxystearic Acid, Silica, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Iron Oxides (CI 77491, CI 77492, CI 77499).

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    MDSOLARSCIENCES CORP.
    GREENS FARMS, CT 06838

  • PRINCIPAL DISPLAY PANEL - 100 ML Tube Carton

    MDSOLARSCIENCES®

    PROTECT & NOURISH

    MINERAL
    KIDCRÈME®

    Broad Spectrum Sunscreen SPF 50
    Water Resistant (80 Min)

    SPF
    50

    Natural, sheer protection
    for humans 6 months + older

    DERMATOLOGIST DEVELOPED

    3.4 FL OZ / 100 ML

    PRINCIPAL DISPLAY PANEL - 100 ML Tube Carton
  • INGREDIENTS AND APPEARANCE
    MINERAL KIDCREME SPF 50 
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-584
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE20 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE170 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    POMEGRANATE JUICE (UNII: 99S671U9KB)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SQUALANE (UNII: GW89575KF9)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containFERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    May containFERRIC OXIDE RED (UNII: 1K09F3G675)  
    May containFERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49358-584-011 in 1 CARTON07/01/2023
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/01/2023
    Labeler - MDSolarSciences (013647301)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab, Inc.172198223MANUFACTURE(49358-584)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!