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Mineral Creme

MDSolarSciences

Mineral Crème Broad Spectrum SPF 30 Sunscreen UVA-UVB Suncreen


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients Purpose
Titanium Dioxide 2% Sunscreen
Zinc Oxide 17% Sunscreen

Mineral Creme 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 10a.m. – 2p.m.
    • -Wear long-sleeved shirts, pants, hats and sunglasses

Mineral Creme Other information

  • Protect the product 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

Dimethicone, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Glyceryl Isostearate, Polyhydroxystearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Butyl Octyl Salicylate, Polysilicone-15, Tetrahexyldecyl Ascorbate, Camellia Sinensis (Green Tea) Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum (Pomegranate) Extract, Iron oxide, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Ubiquinone, Tocopheryl Acetate, Squalane.

PRINCIPAL DISPLAY PANEL - 48 g Tube Carton

MDSolarSciences

30

MINERAL
CRÈME

BROAD SPECTRUM
SPF 30
UVA-UVB SUNSCREEN

+R
enhanced with
ProVention-R™
Antioxidant Complex

Developed & Approved by Dermatologists

water resistant (80 minutes) / non-comedogenic
suited for all skin types including acne & rosacea
formulated without fragrance

Net Wt. 48 g - 1.7 Oz.

Mineral Creme

Mineral Creme

Titanium Dioxide and Zinc Oxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49358-552
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 2.7 g
Zinc Oxide Zinc oxide 1.3 g

Inactive Ingredients

Ingredient Name Strength
DIMETHICONE
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER
MEDIUM-CHAIN TRIGLYCERIDES
GLYCERYL ISOSTEARATE
POLYHYDROXYSTEARIC ACID (2300 MW)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
SILICON DIOXIDE
BUTYLOCTYL SALICYLATE
Polysilicone-15
TETRAHEXYLDECYL ASCORBATE
GREEN TEA LEAF
CRANBERRY
POMEGRANATE JUICE
ferric oxide red
PEG/PPG-18/18 DIMETHICONE
TRIETHOXYCAPRYLYLSILANE
UBIDECARENONE
.ALPHA.-TOCOPHEROL ACETATE
SQUALANE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 48 in 1 TUBE
2 NDC:49358-552-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-03-01


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