MINERAL BEAUTY BALM BROAD SPECTRUM SPF 50 SUNSCREEN UVA-UVB SUNCREEN LIGHT/MEDIUM- titanium dioxide and zinc oxide cream MINERAL BEAUTY BALM BROAD SPECTRUM SPF 50 SUNSCREEN UVA-UVB SUNCREEN MEDIUM/DARK- titanium dioxide and zinc oxide cream

Mineral Beauty Balm by

Drug Labeling and Warnings

Mineral Beauty Balm 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 10 a.m. – 2 p.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 reaction 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, Butyloctyl Salicylate, Polysilicone-15, Tetrahexyldecyl Ascorbate, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Iron Oxide, Caffeine, Niacinamide, Ubiquinone, Tocopheryl Acetate, Squalane, Camellia Sinensis (Green Tea) Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum (Pomegranate) Extract.

PRINCIPAL DISPLAY PANEL - 35 g Tube Carton - Light/Medium

MDSolarSciences™

50

MD CRÈME
MINERAL
BEAUTY BALM

light medium

BROAD SPECTRUM
SPF 50
UVA-UVB SUNSCREEN

+R
enhanced with
ProVention-R™

developed & approved
by Dermatologists

Water resistant (80 minutes)
Non-comedogenic – won't clog pores

sun repair

Net Wt. 35 g - 1.23 Oz.

PRINCIPAL DISPLAY PANEL - 35 g Tube Carton - Medium/Dark

MDSolarSciences™

50

MD CRÈME
MINERAL
BEAUTY BALM

medium dark

BROAD SPECTRUM
SPF 50
UVA-UVB SUNSCREEN

+R
enhanced with
ProVention-R™

developed & approved
by Dermatologists

Water resistant (80 minutes)
Non-comedogenic – won't clog pores

sun repair

Net Wt. 35 g - 1.23 Oz.

INGREDIENTS AND APPEARANCE

MINERAL BEAUTY BALM   BROAD SPECTRUM SPF 50 SUNSCREEN UVA-UVB SUNCREEN LIGHT/MEDIUM
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49358-550
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)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYSILICONE-15 (UNII: F8DRP5BB29)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CAFFEINE (UNII: 3G6A5W338E)
NIACINAMIDE (UNII: 25X51I8RD4)
UBIDECARENONE (UNII: EJ27X76M46)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SQUALANE (UNII: GW89575KF9)
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: 49358-550-01	1 in 1 CARTON	04/01/2014
1		35 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	04/01/2014

MINERAL BEAUTY BALM   BROAD SPECTRUM SPF 50 SUNSCREEN UVA-UVB SUNCREEN MEDIUM/DARK
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49358-551
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)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYSILICONE-15 (UNII: F8DRP5BB29)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CAFFEINE (UNII: 3G6A5W338E)
NIACINAMIDE (UNII: 25X51I8RD4)
UBIDECARENONE (UNII: EJ27X76M46)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SQUALANE (UNII: GW89575KF9)
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: 49358-551-01	1 in 1 CARTON	04/01/2014
1		35 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	04/01/2014

Labeler - MDSolarSciences (013647301)