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 
MDSolarSciences

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Mineral Beauty Balm
Broad Spectrum SPF 50 Sunscreen UVA-UVB Suncreen

Drug Facts

Active IngredientsPurpose
Titanium Dioxide 2%Sunscreen
Zinc Oxide 17% Sunscreen

Uses

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

Other Information

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 - Light/Medium

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.

Principal Display Panel - 35 g Tube Carton - Medium/Dark
MINERAL BEAUTY BALM   BROAD SPECTRUM SPF 50 SUNSCREEN UVA-UVB SUNCREEN LIGHT/MEDIUM
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-550
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide2.7 g  in 35 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide1.3 g  in 35 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49358-550-011 in 1 CARTON04/01/2014
135 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/01/2014
MINERAL BEAUTY BALM   BROAD SPECTRUM SPF 50 SUNSCREEN UVA-UVB SUNCREEN MEDIUM/DARK
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-551
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide2.7 g  in 35 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide1.3 g  in 35 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49358-551-011 in 1 CARTON04/01/2014
135 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/01/2014
Labeler - MDSolarSciences (013647301)

Revised: 1/2020
Document Id: d84e2bc2-d047-46c4-8f29-d3a31b66842d
Set id: 7c3c978d-27b9-49ec-85a0-b2f2e6dc8272
Version: 4
Effective Time: 20200127
 
MDSolarSciences