MINERAL SPF 30 SUN- titanium dioxide and zinc oxide stick

MINERAL SPF 30 SUN by

Drug Labeling and Warnings

MINERAL SPF 30 SUN 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 Ingredients

Titanium Dioxide 5.0%
Zinc Oxide 10.0%

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
• Reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• 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 a 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive ingredients

Cocos Nucifera (Coconut) Oil1, Theobroma Cacao (Cocoa) Seed Butter1, Ricinus Communis (Castor) Seed Oil*, Linum Usitatissimum (Flax) Seed Oil1, Rosa Canina (Rosehip) Oil1, Ginkgo Biloba Leaf Extract1, Olea Europaea (Olive) Leaf Oil1, Rosemary Officinalis (Rosemary) Leaf Oil1, Butyrospermum Parkii (Shea Butter)1, Copernicia Cerifera (Carnauba) Wax1, Helianthus Annuus (Sunflower) Seed Oil1, Mineral Water, Borago Officinalis (Borage) Seed Oil1, Aloe Barbadenis Leaf Oil1, Calendula Officinalis Flower Oil1, Citrus Aurantium Dulcil (Orange) Peel Wax, Pentapeptide, Camellia Sinensis Leaf Oil1, Chamomilla Recutita (Matricaria) Flower Oil1, Cucumis Sativus (Cucumber) Fruit Extract, Cedrus Atlantica (Cedarwood) Bark Oil1, Silica, Pelargonium Graveolens (Geranium) Flower Oil, Vanilla Planifolia Fruit Oil, Panthenol (Vitamin B5), Allantoin, Tocopherol, (Vitamin E).

1 Certified Organic

Questions

Call 1-800-428-1668 Mon-Fri 8 a.m. – 5 p.m. MST

PRINCIPAL DISPLAY PANEL - 9.5 g Cylinder Carton

MINERAL FUSION
minerals on a mission

mineral SPF 30
sun stick
with peptide
age-defense
BROAD SPECTRUM

mineral SPF
spot treatment

for sun-sensitive
areas

all skin types

TREAT

HYPO-ALLERGENIC. 100% VEGAN.

Net Wt 0.33 oz / 9.5 g e

INGREDIENTS AND APPEARANCE

MINERAL SPF 30 SUN 
titanium dioxide and zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55789-2902
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.475 g  in 9.5 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.95 g  in 9.5 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)	5.7 g  in 9.5 g
COCOA BUTTER (UNII: 512OYT1CRR)
CASTOR OIL (UNII: D5340Y2I9G)
LINSEED OIL (UNII: 84XB4DV00W)
ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T)
GINKGO (UNII: 19FUJ2C58T)
OLIVE OIL (UNII: 6UYK2W1W1E)
ROSEMARY (UNII: IJ67X351P9)
SHEANUT OIL (UNII: O88E196QRF)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SUNFLOWER OIL (UNII: 3W1JG795YI)
WATER (UNII: 059QF0KO0R)
BORAGE OIL (UNII: F8XAG1755S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CITRUS SINENSIS FLOWER WAX (UNII: 8L3Z7JK2NU)
THYMOPENTIN (UNII: O3Y80ZF13F)
TEA LEAF OIL (UNII: VC855RRT77)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
CUCUMIS SATIVUS LEAF (UNII: Q6S42514LP)
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
VANILLA PLANIFOLIA OIL (UNII: 0A3F415158)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
TOCOPHEROL (UNII: R0ZB2556P8)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55789-2902-1	1 in 1 CARTON
1		9.5 g in 1 CYLINDER; 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)