MINERAL  BROAD SPECTRUM SPF 50 SUNSCREEN UVA-UVB SUNCREEN- titanium dioxide and zinc oxide cream 
MDSolarSciences

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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Mineral Crème
Broad Spectrum SPF 50 Sunscreen UVA-UVB Suncreen

Drug Facts

Active IngredientsPurpose
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 (GreenTea) Extract, Vaccinium Macrocarpon (Cranbery) Fruit Extract, Punica Granatum (Pomegranate) Extract

PRINCIPAL DISPLAY PANEL - 48 g Tube Carton

MDSolarSciences

50

MINERAL
CRÈME

BROAD SPECTRUM
SPF 50
UVA-UVB SUNSCREEN

+R
enhanced with
ProVention-R™

developed & approved
by Dermatologists

Water resistant (80 minutes)
Non-comedogenic – won't clog pores

sun care

Net Wt. 48 g - 1.7 Oz

Principal Display Panel - 48 g Tube Carton
MINERAL   BROAD SPECTRUM SPF 50 SUNSCREEN UVA-UVB SUNCREEN
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-554
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide2.7 g  in 35 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide1.3 g  in 35 g
Inactive Ingredients
Ingredient NameStrength
Dimethicone (UNII: 92RU3N3Y1O)  
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CRANBERRY (UNII: 0MVO31Q3QS)  
POMEGRANATE JUICE (UNII: 99S671U9KB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49358-554-011 in 1 CARTON01/01/2016
148 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/01/2016
Labeler - MDSolarSciences (013647301)

Revised: 9/2018
Document Id: 292e0333-b4bb-418e-82b3-508ac164bb87
Set id: 08979dbf-bf68-4dae-86d1-e5a9ffd0b016
Version: 5
Effective Time: 20180926
 
MDSolarSciences