MINERAL SPF 30 BRUSH-ON SUN DEFENSE- titanium dioxide and zinc oxide powder

Mineral SPF 30 Brush-On Sun Defense by

Drug Labeling and Warnings

Mineral SPF 30 Brush-On Sun Defense by is a Otc medication manufactured, distributed, or labeled by Mineral Fusion brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Titanium Dioxide 17.3%	Sunscreen
Zinc Oxide 20.0%	Sunscreen

Uses

• Helps prevent sunburn.
• Higher SPF gives more sunburn protection.

Warnings

• When using this product keep out of eyes.
• Rinse with water to remove.
• Stop use and ask doctor if rash or irritation develops and lasts.

• Keep out of reach of children.

Directions

• Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months of age: ask a doctor.

Inactive Ingredients

Mica, Silica, Nylon-12, Caprylic/Capric Triglyceride, Tocopherol, Capryloyl Glycine, Undecylenoyl Glycine, Alaria Esculenta (Sea Kelp) Extract, Retinyl Palmitate, Iron Oxides.

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 PST

SPL UNCLASSIFIED SECTION

Dist. by Mineral Fusion
Petaluma, CA 94954 USA

PRINCIPAL DISPLAY PANEL - 4 g Tube Carton

Mineral SPF 30
Brush-On Sun Defense

Translucent Matte Finish
For All Skin Tones
Broad Spectrum Protection

MINERAL
FUSION®

BRUSH-ON
SPF 30
PROTECTION

Making Beauty Healthy®

Net Wt 0.14 oz e 4.0 g

INGREDIENTS AND APPEARANCE

MINERAL SPF 30 BRUSH-ON SUN DEFENSE 
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55789-1221
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	173 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
UNDECYLENOYL GLYCINE (UNII: 4D20464K2J)
ALARIA ESCULENTA (UNII: EJ9JK8J58D)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TOCOPHEROL (UNII: R0ZB2556P8)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55789-1221-1	1 in 1 CARTON	12/31/2019
1		4 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/31/2019

Labeler - Mineral Fusion brands (831770032)