BRONZING MINERAL BEAUTY BALM SPF 15- titanium dioxide and zinc oxide cream 
Mineral Fusion Natural Brands

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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BRONZING MINERAL BEAUTY BALM SPF 15

Drug Facts

Active Ingredient

Titanium Dioxide 6%
Zinc Oxide 4%

Purpose

Sunscreen

Uses

Warnings

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.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value 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.

Inactive Ingredients

Aqua, Polysorbate 20, Cetyl Alcohol, Stearyl Alcohol, Tocopherol, Dimethicone, Emulsifying Wax, Caprylic/Capric Triglyceride, Glycerin, Hydroxyethylcellulose, Sodium Hydroxide, Alcohol, Coco-caprylate/Caprate, Sodium Alginate, Xanthan Gum, Butyrospermum Parkii (Shea Butter), Aloe Barbadensis (Aloe) Leaf Juice, Palmitoyl Tripeptide-5, Lavandula Angustifolia (Lavender) Flower Extract, Roman Anthemis Nobilis (Chamomile) Flower Extract, Rosa Canina (Rosehip) Oil*, Ginkgo Biloba Extract, Romarinus Officinalis (Rosemary) Leaf Extract, Thymus Vulgaris (Thyme) Extract, Punica Granatum (Pomegranate) Seed Oil, Ascorbic Acid. May Contain: Mica, Red Iron Oxide, Yellow Iron Oxide, Black Iron Oxide.

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 Carton

bronzing
mineral beauty balm
broad spectrum SPF 15

BRONZE FINISH
sunkissed glow for all skin tones

MINERAL FUSION®
minerals on a mission®

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 Carton
BRONZING MINERAL BEAUTY BALM SPF 15 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55789-2403
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.6 g  in 60 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 42 mL  in 60 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TOCOPHEROL (UNII: R0ZB2556P8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (3000 MPA.S AT 1%) (UNII: 7Q6P4JN1QT)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ALCOHOL (UNII: 3K9958V90M)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SHEA BUTTER (UNII: K49155WL9Y)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T)  
GINKGO (UNII: 19FUJ2C58T)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
THYME (UNII: CW657OBU4N)  
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55789-2403-11 in 1 CARTON
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 FINALpart35208/01/2014
Labeler - Mineral Fusion Natural Brands (831770032)

Revised: 8/2015
Document Id: 730bf52d-6063-45a8-9692-2c801ea6a9de
Set id: e2bc3c46-e2ab-4e47-93ec-46d15e7f9197
Version: 1
Effective Time: 20150828
 
Mineral Fusion Natural Brands