MDSOLARSCIENCES SPF 50 MINERAL- titanium dioxide and zinc oxide cream

MDSOLARSCIENCES by

Drug Labeling and Warnings

MDSOLARSCIENCES by is a Otc medication manufactured, distributed, or labeled by MD Solar Sciences. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
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
  • - 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

• 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 Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum Extract

PRINCIPAL DISPLAY PANEL - 48 g Tube Carton

MDSolarSciences™

50

MINERAL
CRÈME

BROAD SPECTRUM
SPF 50
UVA-UVB SUNSCREEN

+R
enhanced with
ProVention-R™
Antioxidant Complex

Developed & Approved by Dermatologists

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

Net Wt. 48 g - 1.7 Oz.

INGREDIENTS AND APPEARANCE

MDSOLARSCIENCES   SPF 50 MINERAL
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49358-546
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	15 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	170 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Dimethicone (UNII: 92RU3N3Y1O)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Glyceryl Isostearate (UNII: HYE7O27HAO)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Polysilicone-15 (UNII: F8DRP5BB29)
PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Cranberry (UNII: 0MVO31Q3QS)
Punica Granatum Root Bark (UNII: CLV24I3T1D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49358-546-01	1 in 1 CARTON
1		48 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/01/2013

Labeler - MD Solar Sciences (013647301)