MDSOLARSCIENCES  SPF 50 MINERAL- titanium dioxide and zinc oxide cream 
MD Solar Sciences

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.

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MDSOLARSCIENCES™
SPF 50 Mineral Crème

Drug Facts

Active ingredients Purpose
Titanium Dioxide 1.5% Sunscreen
Zinc Oxide 17% Sunscreen

Uses

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.

Other information

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.

PRINCIPAL DISPLAY PANEL - 48 g Tube Carton
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 DEA Schedule     
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)

Revised: 1/2013
Document Id: bed494be-e4a1-4c46-8341-eee1a25f4cf8
Set id: fb4055fd-657a-4931-b322-df0440fb0023
Version: 1
Effective Time: 20130122
 
MD Solar Sciences