MDSOLARSCIENCES SPF50 PLUS ULTRA MINERAL SCREEN- titanium dioxide and zinc oxide gel

MDSolarSciences SPF50 Plus Ultra Mineral Screen by

Drug Labeling and Warnings

MDSolarSciences SPF50 Plus Ultra Mineral Screen by is a Otc medication manufactured, distributed, or labeled by Ecometics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Igredients

Titanium Dioxide 10.3% .............Sunscreen

Zinc Oxide 5.5% ...................Sunscreen

Uses

Helps prevent sunburn
Higher SPF gives more sunburn protection

Warnings

For external uses only.

When using this product
keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if
rash or irritation develops and lasts.

Keep out of reach of children.
If swallowed, get medical
help or contact a Poison Control Center right away

Directions

Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure.
Rub in well. Reapply often (every 2 hours) and after swimming, excessive perspiration and washing.
Children under 6 months of age ask a doctor. Effective sun protection for children under 2 years
of age is strongly recommended.

Other Information

Sun alert: Limiting sun exposure, wearing protective
clothing, and using sunscreen may reduce the risk of skin
aging, skin cancer, and other harmful effects of the sun.
May stain clothing.
You may report serious adverse reactions to Report Reactions, LLC, PO Box 22, Plainsboro, NJ 08536-0222

Inactive Ingredients

Cyclopentasiloxane, Dimethicone Crosspolymer,
Dimethicone, C30-45 Olefin, Phenyl Methicone,
Dimethicone/Vinyl Dimethicone Crosspolymer, Lauryl
PEG/PPG-18/18 Methicone, Polymethylsilsesquioxane,
Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone,
Stearoxytrimethylsilane, Aluminum Hydroxde, Stearic Acid,
Dimethiconol, Triethoxysilylethyl Polymethylsiloxyethyl
Hexyl Dimethicone

Principle Display Panel

MDSolarSciences
SPF 50 Plus
with
Broad Spectrum
UVA-UVB Sunscreen
Ultra Mineral Screen Gel
Sensitive Skin Formula
Enhanced Sunscreen Protection
Silky Smooth Application
Non-greasy. No Fragrance
For Adults and Children
50g - 1.76 Oz

Additional Carton Labeling

MDSolarSciences Corp
40 Richards Avenue, 3rd Floor, Norwalk, CT 06854
www.mdsolarsciences.com
Patent Pending
UPC 8 55488 00202 8

ULTRA MINERAL SCREEN GEL
Safe, Effective & Elegant
Suncreen For Sensitive Skin
Zinc & Titanium based
Free of chemical actives
Broad Spectrum Protection
UVB ("Burning" rays) SPF 50 Plus
UVA ("Aging" rays) Formulated
to meet European standards
Elegant Cosmesis
Silky smooth
Clear when rubbed in well

Also Available from
MDSolarSciences:
No Touch Body Spray SPF 40
Ulta-Sport Stick SPF40
Mineral Screen Lotion SPF40
Mineral Screen Gel SPF30 Plus

A complete sun
protection routine
can help to reduce
photo-aging and the
incidence of skin cancer

The use of broad
spectum (UVA and UVB) sunscreens is
only one element of safer sun practices.
It is also important to
take the following
sun-safety measures:

SUN SAFE TIPS:

Wear Protective Clothing
A long sleeved shirt, pants,
a wide-brimmed hat and
sunglasses should be worn
where possible

Seek Shade
Remember that the sun's
rays are strongest between
10am and 4pm. Learn the
UV Index and be aware of
the strength of the sun's rays.

Avoid Tanning Beds
UV light from the sun and
tanning beds may cause
skin cancer and wrinkling

Get Vitamin D Safely
Add vitamin supplements
to a healthy diet in
consultation with your physician.

INGREDIENTS AND APPEARANCE

MDSOLARSCIENCES SPF50 PLUS ULTRA MINERAL SCREEN 
titanium dioxide and zinc oxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17452-380
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10.3 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17452-380-01	50 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2010

Labeler - Ecometics, Inc (064843923)