Your browser does not support JavaScript! MDSOLARSCIENCES SPF 50 MINERAL (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [MD SOLAR SCIENCES]
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MDSOLARSCIENCES SPF 50 MINERAL (titanium dioxide and zinc oxide) lotion
[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 ingredients:Purpose:
Titanium Dioxide 3%Sunscreen
Zinc Oxide 15%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 a.m. - 2 p.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

Water, Dimethicone, Dimethicone Crosspolymer, Dimethicone/PEG-10/15 Crosspolymer, Octyldodecanol, Quaternium-90 Bentonite, Propylene Carbonate, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Polysilicone-15, PEG-10 Dimethicone, Camellia Sinensis (Green Tea) Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum Extract, Tetrahexyldecyl Ascorbate, Magnesium Aluminum Silicate, Sodium Chloride, Sodium Citrate, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Caprylhydroxamic acid, Caprylyl Glycol, Glycerin

PRINCIPAL DISPLAY PANEL - 78 g Tube Carton

MDSolarSciences

MINERAL
LOTION

for Face & Body

BROAD SPECTRUM
SPF 50
UVA-UVB SUNSCREEN

+R
enhanced with
ProVention-R™
Antioxidant Complex

Developed & Approved by Dermatologists

water resistant (80 minutes) / non-comedogenic
silky smooth and moisturizing
suited for all ages & skin types
formulated without fragrance

Net Wt. 78 g - 2.75 Oz.

PRINCIPAL DISPLAY PANEL - 78 g Tube Carton
MDSOLARSCIENCES   SPF 50 MINERAL
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49358-548
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE30 mg  in 1 g
Zinc Oxide (Zinc Oxide) Zinc Oxide150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Dimethicone 
Octyldodecanol 
Propylene Carbonate 
Butyloctyl Salicylate 
Polysilicone-15 
Green Tea Leaf 
Cranberry 
Punica Granatum Root Bark 
Tetrahexyldecyl Ascorbate 
Magnesium Aluminum Silicate 
Sodium Chloride 
Sodium Citrate 
Hyaluronate Sodium 
Aloe Vera Leaf 
Chamomile 
Caprylhydroxamic acid 
Caprylyl Glycol 
Glycerin 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49358-548-011 in 1 CARTON
178 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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