ILLUMINATING MINERAL BEAUTY BALM WITH SPF 9- titanium dioxide cream 
Mineral Fusion Natural Brands LLC

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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Illuminating Mineral Beauty Balm with SPF 9

Drug Facts

Active Ingredient

Titanium Dioxide 7.4%

Purpose

Sunscreen

Uses

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early aging.

  • For external use only.

  • Do not use on damaged or broken skin.

  • When using this product keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor if rash occurs.

  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure.

Inactive Ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Jojoba Esters, Mica, Vegetable Glycerin, Sorbitan Sesquioleate, Cetearyl Olivate, Sorbitan Olivate, Potassium Cetyl Phosphate, Dimethicone, Hydroxyethylcellulose, Citric Acid, Punica Granatum (Pomegranate) Extract, Tetrahexyldecyl Ascorbate (Vitamin C), Mineral-Peptide Blend (Magnesium Asparate, Zinc Gluconate, Copper Gluconate, and Palmitoyl Tripeptide-5), Camellia Sinensis (White Tea) Leaf Extract, Aloe Barbadensis Leaf Juice, Glycyrrhiza Glabra (Licorice) Extract, Lavandula Angustifolia (Lavender) Extract, Rosa Canina (Rose) Flower Extract, Olea Europaea (Olive) Leaf Extract, Potassium Sorbate, Sodium Dehydroacetate, Sodium Benzoate, Iron Oxides (CI 77491, CI 77492, CI 77499).

Other Information

Protect this product from excessive heat and direct sun.

Questions or Comments?

Call toll free 1-800-428-1668 Mon-Fri 8 AM-5 PM MST

PRINCIPAL DISPLAY PANEL - 60 ml Tube Label

MINERAL FUSION®
minerals on a mission®

illuminating
mineral beauty balm
broad spectrum SPF 9

LUMINOUS FINISH
Ultra-sheer for all skin tones

ALL-IN-ONE
BB

Makeup + moisturizer
+ age-defying treatment

Hypo-allergenic, Fragrance free

2.0 fl oz / 60 mL e

Principal Display Panel - 60 ml Tube Label
ILLUMINATING MINERAL BEAUTY BALM WITH SPF 9 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55789-2401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE74 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
JOJOBA OIL (UNII: 724GKU717M)  
MICA (UNII: V8A1AW0880)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
COPPER GLUCONATE (UNII: RV823G6G67)  
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55789-2401-11 in 1 CARTON04/01/2013
160 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/01/2013
Labeler - Mineral Fusion Natural Brands LLC (831770032)
Establishment
NameAddressID/FEIBusiness Operations
Columbia Cosmetics068267863MANUFACTURE(55789-2401)

Revised: 9/2019
Document Id: d59b0bff-ce62-46fb-bc16-126c45eb7bd7
Set id: 3e6e97f8-1179-4ea4-a266-946f0ab7f480
Version: 6
Effective Time: 20190917
 
Mineral Fusion Natural Brands LLC