Your browser does not support JavaScript! MDSOLARSCIENCES SPF 30 MINERAL TINTED (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MD SOLAR SCIENCES]
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MDSOLARSCIENCES SPF 30 MINERAL TINTED (titanium dioxide and zinc oxide) cream
[MD Solar Sciences]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

Drug Facts

Active ingredientsPurpose
Titanium Dioxide 1.5%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

Shake well. Rub in well.

  • Apply liberally 15 minutes before sun exposure
  • Reapply:
    -
    After 80 minutes of swimming or sweating
    -
    Immeditately 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

  • 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, Silica, Butyloctyl Salicylate, Polysilicone-15, Dimethicone/Vinyl Dimethicone Crosspolymer, Iron Oxides, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Tetrahexyldecyl Ascorbate, Camellia Sinensis Leaf Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum Extract

PRINCIPAL DISPLAY PANEL - 48 g Tube Carton

MDSolarSciences

30

MINERAL
TINTED
CRÈME

BROAD SPECTRUM
SPF 30
UVA-UVB SUNSCREEN

enhanced with
ProVention-R
Antioxidant Complex
+R

Developed & Approved by Dermatologists

water resistant (80 minutes) / non-comedogenic
suited for all skin types including acne & rosacea
formulated without fragrance / matte finish

Net Wt. 48 g - 1.7 Oz.

PRINCIPAL DISPLAY PANEL - 48 g Tube Carton
MDSOLARSCIENCES   SPF 30 MINERAL TINTED
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49358-547
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE15 mg  in 1 g
Zinc Oxide (Zinc Oxide) Zinc Oxide170 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dimethicone 
Medium-Chain Triglycerides 
Glyceryl Isostearate 
Silicon Dioxide 
Butyloctyl Salicylate 
Polysilicone-15 
PEG/PPG-18/18 Dimethicone 
Triethoxycaprylylsilane 
Tetrahexyldecyl Ascorbate 
Green Tea Leaf 
Cranberry 
Punica Granatum Root Bark 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49358-547-011 in 1 CARTON
148 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35202/01/2013
Labeler - MD Solar Sciences (013647301)

Revised: 1/2013
 
MD Solar Sciences

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