Label: KIDCREME MINERAL BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNCREEN- 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 October 25, 2018

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, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Glyceryl Isostearate, Polyhydroxystearic Acid, Dimethicone/ Vinyl Dimethicone Crosspolymer, Silica, Butyl Octyl Salicylate Polysilicone-15, Tetrahexyldecyl Ascorbate, Camellia Sinensis (Green Tea) Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum (Pomegranate) Extract, Iron oxide, PEG/PPG-18/18 Dimethicone, Triethoxy-caprylylsilane, Ubiquinone, Tocopheryl Acetate, Squalane

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    MDSolarSciences Corp.
    Stamford, CT 06902

  • PRINCIPAL DISPLAY PANEL - 71 g Tube Carton

    MDSolarSciences™

    40
    KidCrème

    MINERAL SUNSCREEN

    BROAD SPECTRUM
    SPF 40
    UVA-UVB SUNSCREEN

    Gentle enough for sensitive skin

    Safe for children
    6 months and older

    Dermatologist developed,
    approved & recommended

    Water resistant (80 minutes)
    Non-Comedogenic–Won't clog pores
    Oil-Free–Fragrance-Free

    sun care

    Net Wt. 71g -2.54Oz

    Principal Display Panel - 71 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    KIDCREME   MINERAL BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNCREEN
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-559
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide2.7 g  in 35 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide1.3 g  in 35 g
    Inactive Ingredients
    Ingredient NameStrength
    Dimethicone (UNII: 92RU3N3Y1O)  
    DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    POMEGRANATE JUICE (UNII: 99S671U9KB)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SQUALANE (UNII: GW89575KF9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49358-559-011 in 1 CARTON06/16/2017
    148 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35206/16/2017
    Labeler - MDSolarSciences (013647301)
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!