MINERAL CREME BROAD SPECTRUM SPF 48 SUNSCREEN UVA-UVB SUNCREEN- titanium dioxide and zinc oxide cream

Mineral Creme by

Drug Labeling and Warnings

Mineral Creme by is a Otc medication manufactured, distributed, or labeled by MDSolarSciences. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

• 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

Other Information

Shake well. Rub in well.

• 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, Silica,Dimethicone/Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate,Polysilicone-15, Iron Oxides, PEG/PPG-18/18 Dimethicone,Triethoxycaprylylsilane, Tetrahexyldecyl Ascorbate, Camellia Sinensis (GreenTea) Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum (Pomegranate) Extract

SPL UNCLASSIFIED SECTION

Distributed by:
MDSolarSciences Corp.
Stamford, CT 06902

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

MDSolarSciences™

48
MINERAL
CRÈME

BROAD SPECTRUM
SPF 48
UVA-UVB SUNSCREEN

+R
enhanced with
ProVention-R™
antioxidant complex

Dermatologist developed,
approved & recommended

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

Net Wt. 113 g - 4 Oz.

INGREDIENTS AND APPEARANCE

MINERAL CREME   BROAD SPECTRUM SPF 48 SUNSCREEN UVA-UVB SUNCREEN
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49358-561
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	2.7 g  in 35 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	1.3 g  in 35 g

Inactive Ingredients
Ingredient Name	Strength
Dimethicone (UNII: 92RU3N3Y1O)
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYSILICONE-15 (UNII: F8DRP5BB29)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CRANBERRY (UNII: 0MVO31Q3QS)
POMEGRANATE JUICE (UNII: 99S671U9KB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49358-561-02	1 in 1 CARTON	05/01/2018
1	NDC: 49358-561-01	113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	05/01/2018

Labeler - MDSolarSciences (013647301)