BRONZING MINERAL BEAUTY BALM SPF 15- titanium dioxide and zinc oxide cream

BRONZING MINERAL BEAUTY BALM SPF 15 by

Drug Labeling and Warnings

BRONZING MINERAL BEAUTY BALM SPF 15 by is a Otc medication manufactured, distributed, or labeled by Mineral Fusion Natural Brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Titanium Dioxide 6%
Zinc Oxide 4%

Purpose

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

• 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.

• Use a water resistant sunscreen if swimming or sweating.
• Reapply 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 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

INGREDIENTS AND APPEARANCE

BRONZING MINERAL BEAUTY BALM SPF 15 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55789-2403
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.6 g  in 60 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55789-2403-1	1 in 1 CARTON
1		60 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	08/01/2014

Labeler - Mineral Fusion Natural Brands (831770032)