MINERAL TINTED SUNSCREEN  BROAD SPECTRUM SPF 30 SUNSCREEN UVA-UVB SUNCREEN- 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 Tinted Sunscreen Stick
Broad Spectrum SPF 30 Sunscreen UVA-UVB Sunscreen

Drug Facts

Active IngredientsPurpose
Titanium Dioxide 8.25%Sunscreen
Zinc Oxide 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, Polyhydro- xystearic Acid, Cetyl PEG/PPG10/1 Dimeth- icone, BHT, Octyldodec- anol, Iron Oxides, Sorbitan Oleate, Citric Acid Benzylidene Dimethoxydimethylindanone, Tetrahexyldecyl Ascorbate

Distributed by:
MDSolarSciences Corp.
Stamford, CT 06902

PRINCIPAL DISPLAY PANEL - 17 g Tube Carton

MDSolarSciences™

30

MINERAL
TINTED
SUNSCREEN STICK

BROAD SPECTRUM
SPF 30
UVA-UVB SUNSCREEN

+R
enhanced with
ProVention-R™
antioxidant complex

Dermatologists developed,
approved & recommended

Water resistant (80 minutes)
Non-Comedogenic – Won't clog pores
Oil-Free – Fragrance-Free

sun care

Net Wt. 17g -0.6Oz

PRINCIPAL DISPLAY PANEL - 17 g Tube Carton
MINERAL TINTED SUNSCREEN   BROAD SPECTRUM SPF 30 SUNSCREEN UVA-UVB SUNCREEN
titanium dioxide and zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-563
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)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49358-563-011 in 1 CARTON09/16/2019
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 finalpart35209/16/2019
Labeler - MDSolarSciences (013647301)

Revised: 8/2019
Document Id: 04802a76-f6cb-4050-bb7d-b93e3fab9ad4
Set id: 05400f51-6c23-40d9-9e9c-dc3f6bfb6da0
Version: 1
Effective Time: 20190805
 
MDSolarSciences