MINERAL CREME SPF 50 MINERAL CREME SPF 50 BROAD SPECTRUM UVA-UVB SUNSCREEN WATER RESISTANT (80 MIN)- titanium dioxide and zinc oxide cream

Mineral Creme SPF 50 by

Drug Labeling and Warnings

Mineral Creme SPF 50 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 611,
  Pompton Plains, NJ 07444

Inactive Ingredients

Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Glyceryl Isostearate, Polysilicone-15, Tetrahexyldecyl Ascorbate (Vitamin C), Camellia Sinensis Leaf Extract (Green Tea), Punica Granatum Extract (Pomegranate), Vaccinium Macrocarpon (Cranberry) Fruit Extract, Silica, Polyhydroxystearic Acid, May Contain: (CI 77891, CI 77492, CI 77491, CI 77499)

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
MDSOLARSCIENCES CORP.
GREENS FARMS, CT 06838

PRINCIPAL DISPLAY PANEL - 100 ML Tube Carton

MDSOLARSCIENCES®

MINERAL
CRÈME

Broad Spectrum SPF 50
Water Resistant (80 Min)
100% Mineral Sunscreen

SPF 50

Invisible, Weightless
Protection Enriched
with Antioxidants

DERMATOLOGIST
DEVELOPED

VITAMIN C
POMEGRANATE

GREEN TEA
CRANBERRY

3.4 FL OZ / 100 ML

INGREDIENTS AND APPEARANCE

MINERAL CREME SPF 50   MINERAL CREME SPF 50 BROAD SPECTRUM UVA-UVB SUNSCREEN WATER RESISTANT (80 MIN)
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49358-570
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	20 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	170 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Dimethicone (UNII: 92RU3N3Y1O)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
POLYSILICONE-15 (UNII: F8DRP5BB29)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POMEGRANATE JUICE (UNII: 99S671U9KB)
CRANBERRY (UNII: 0MVO31Q3QS)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
May contain	FERRIC OXIDE RED (UNII: 1K09F3G675)
May contain	FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49358-570-01	1 in 1 CARTON	07/01/2023
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49358-570-02	1 in 1 CARTON	07/01/2023
2		100 mL 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	07/01/2023

Labeler - MDSolarSciences (013647301)