MDSOLARSCIENCES Natural Mineral Sunscreen Kid

Dosage form: cream
Ingredients: Titanium Dioxide 6.16g in 80g, Zinc Oxide 3.04g in 80g
Labeler: MD Solar Sciences
NDC Code: 49358-543

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.

Natural Mineral Sunscreen Kid Crème

Drug Facts

Active Ingredients:Purpose
Titanium Dioxide 7.7%Sunscreen
Zinc Oxide 3.8%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

Shake well. Rub in well.

  • 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 10 am – 2 pm
    • Wear long-sleeved shirts, pants, hats and sunglasses

Other information
  • Protect the products 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

Cyclopentasiloxane, Carylyl Methicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Dimethicone, C30-45 Olefin, Phenyl Methicone, Stearoxytrimethylsilane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Aluminum Hydroxide, Stearic Acid, Trithoxysilyethyl Polydimethylsiloxyethyl Hexyl Dimenthicone, Lauryl PEG/PPG-18/18 Methicone, Triethoxycaprylsilane, Iron Oxides

PRINCIPAL DISPLAY PANEL - 80g Tube Carton

MDSolarSciences

SPF 43
Broad Spectrum

UVA-UVB Protection

natural mineral
Sunscreen
KidCrème

Water Resistant (80 min)
Naturally Derived Mineral Actives
Gentle, Fragrance Free, Easy Application

Safe for Sensitive Skin
FEEL THE DIFFERENCE

For Children 6 Months and Older
DEVELOPED BY DERMATOLOGISTS

Includes our
SolALERT
UV Index
Card

Net Weight 80g - 2.82 Oz.

MDSOLARSCIENCES   NATURAL MINERAL SUNSCREEN KID
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-543
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide6.16 g  in 80 g
Zinc Oxide (Zinc Oxide) Zinc Oxide3.04 g  in 80 g
Inactive Ingredients
Ingredient NameStrength
Cyclomethicone 5 
Dimethicone 
C30-45 Olefin 
Stearoxytrimethylsilane 
Aluminum Hydroxide 
Stearic Acid 
Lauryl PEG/PPG-18/18 Methicone 
Triethoxycaprylylsilane 
Packaging
#Item CodePackage Description
1NDC:49358-543-011 TUBE in 1 CARTON
180 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2012
Labeler - MD Solar Sciences (013647301)

Revised: 04/2012
 
MD Solar Sciences

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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