MDSOLARSCIENCES  NATURAL MINERAL SUNSCREEN TINTED- titanium dioxide and zinc oxide gel 
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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Natural Mineral Sunscreen Tinted Gel

Drug Facts

Active ingredients:Purpose
Titanium dioxide 7.7%Sunscreen
Zinc oxide 3.8%Sunscreen

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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.

  • Apply liberally 15 minutes before sun exposure
  • Reapply:
-
After 80 minutes of swimming or sweating
-
Immediately after towel drying
-
At least every 2 hours
-
Children under 6 months: Ask a doctor
  • Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 am – 2 pm
    • Wear long-sleeved shirts, pants, hats and sunglasses

Other information

-
Protect the products in this container from excessive heat and direct sunlight.
-
May stain some fabrics
-
You may report serious adverse reactions to
Report Reaction, LLC. PO Box 22
Plainsboro, NJ 08536-0222

Inactive ingredients

Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethicone, Stearoxytrimethylsilane, C30-45 Olefin, Phenyl Methicone, Lauryl PEG/PPG-18/18 Methicone, Polymethylsilsesquioxane, Dimethiconol, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Aluminum Hydroxide, Stearic Acid, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Triethoxycaprylsilane, Iron Oxides

PRINCIPAL DISPLAY PANEL - 35 g Carton

MDSolarSciences

SPF 30+
Broad Spectrum

Sunscreen

Mineral Screen
TINTED GEL
UVA-UVB

SENSITIVE SKIN FORMULA
FOR FACE

Silky Smooth Application

Water Resistant (80 min)

Non-Comedogenic (won't clog pores)
Non-greasy • No Fragrance
Suited for Acne/Rosacea Prone Skin

DEVELOPED BY DERMATOLOGISTS

Includes our
SolALERT
UV Index
Card

Net Weight 35 g - 1.23 Oz.

Principal Display Panel - 35 g Carton
MDSOLARSCIENCES   NATURAL MINERAL SUNSCREEN TINTED
titanium dioxide and zinc oxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-542
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 OXIDE1.33 g  in 35 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
C30-45 OLEFIN (UNII: 6DWD51M0O8)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49358-542-011 in 1 CARTON02/01/201208/01/2023
135 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/201208/01/2023
Labeler - MD Solar Sciences (013647301)

Revised: 8/2023
 
MD Solar Sciences