MDSOLARSCIENCES NATURAL MINERAL SUNSCREEN KID- titanium dioxide and zinc oxide cream

MDSOLARSCIENCES by

Drug Labeling and Warnings

MDSOLARSCIENCES by is a Otc medication manufactured, distributed, or labeled by MD Solar Sciences. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL - 80g Tube Carton

MDSolarSciences

SPF 43
Broad Spectrum
UVA-UVB Protection

natural mineral
Sunscreen
KidCrème

Water Resistant (80 min)
Naturally Derived Mineral Actives
Gentle, Fragrance Free, Easy Application

Safe for Sensitive Skin
FEEL THE DIFFERENCE

For Children 6 Months and Older
DEVELOPED BY DERMATOLOGISTS

Includes our
SolALERT
UV Index
Card

Net Weight 80g - 2.82 Oz.

INGREDIENTS AND APPEARANCE

MDSOLARSCIENCES   NATURAL MINERAL SUNSCREEN KID
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49358-543
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	6.16 g  in 80 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	3.04 g  in 80 g

Inactive Ingredients
Ingredient Name	Strength
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Dimethicone (UNII: 92RU3N3Y1O)
C30-45 Olefin (UNII: 6DWD51M0O8)
Stearoxytrimethylsilane (UNII: 9862TW94B2)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Stearic Acid (UNII: 4ELV7Z65AP)
Lauryl PEG/PPG-18/18 Methicone (UNII: ZJ5S27D9NX)
Triethoxycaprylylsilane (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49358-543-01	1 in 1 CARTON
1		80 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2012

Labeler - MD Solar Sciences (013647301)