MINERAL SUNSCREEN  BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN- titanium dioxide and zinc oxide stick 
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 Sunscreen Stick
Broad Spectrum SPF 40 Sunscreen UVA-UVB Sunscreen

Drug Facts

Active IngredientsPurpose
Titanium Dioxide 8.1%Sunscreen
Zinc Oxide 6.6%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

Other information

Inactive Ingredients

Polyethylene, Dimethicone, Butyrospermum Parkii (Shea) Butter, Petrolatum, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Undecylcrylene Dimethicone, Neopentyl Glycol Diheptanoate, Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Behenyl Olivate, Aluminum Hydroxide, Stearic Acid, Glyceryl Isostearate, Beeswax, Polyhydroxystearic Acid, Cetyl PEG/PPG- 10/1 Dimethicone, BHT, Benzylidene Dimethoxydimethylindanone, Tetrahexyldecyl Ascorbate

Distributed by:
MDSolarSciences Corp.
40 Richards Avenue, 3rd Fl., Norwalk, CT 06854

PRINCIPAL DISPLAY PANEL - 17 g Tube Carton

MDSolarSciences

40
MINERAL
SUNSCREEN STICK

BROAD SPECTRUM
SPF 40
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. 17 g - 0.6 Oz.

Principal Display Panel - 17 g Tube Carton
MINERAL SUNSCREEN   BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN
titanium dioxide and zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-553
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.96 g  in 12 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.792 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Dimethicone (UNII: 92RU3N3Y1O)  
SHEA BUTTER (UNII: K49155WL9Y)  
PETROLATUM (UNII: 4T6H12BN9U)  
BUTYLOCTYL OLEATE (UNII: 2830Y2FNR6)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
BEHENYL OLIVATE (UNII: NGS1GGK4GW)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49358-553-011 in 1 CARTON02/01/2016
117 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35202/01/2016
Labeler - MDSolarSciences (013647301)

Revised: 10/2018
Document Id: 039a9fac-5a9d-4219-b101-6c8dba730da4
Set id: bce5be25-a7f8-4cea-a6a9-c2e9ac5dad6a
Version: 3
Effective Time: 20181018
 
MDSolarSciences