MDSOLARSCIENCES  SPF 50 MINERAL- titanium dioxide and zinc oxide lotion 
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 Lotion

Drug Facts

Active ingredients: Purpose:
Titanium Dioxide 3% Sunscreen
Zinc Oxide 15% 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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:49358-548
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 30 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 150 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
Dimethicone (UNII: 92RU3N3Y1O)  
Octyldodecanol (UNII: 461N1O614Y)  
Propylene Carbonate (UNII: 8D08K3S51E)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Polysilicone-15 (UNII: F8DRP5BB29)  
Green Tea Leaf (UNII: W2ZU1RY8B0)  
Cranberry (UNII: 0MVO31Q3QS)  
Punica Granatum Root Bark (UNII: CLV24I3T1D)  
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
Sodium Chloride (UNII: 451W47IQ8X)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Chamomile (UNII: FGL3685T2X)  
Caprylhydroxamic acid (UNII: UPY805K99W)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49358-548-01 1 in 1 CARTON
1 78 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: c0669e4f-4fd4-42ab-8c09-151ef9775e96
Set id: a49364c0-8e32-4d4d-884d-e18a32c4a5c7
Version: 1
Effective Time: 20130123
 
MD Solar Sciences