MINERAL SPF 30 BRUSH-ON SUN DEFENSE- titanium dioxide and zinc oxide powder
Mineral Fusion 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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Mineral SPF 30 Brush-On Sun Defense

Drug Facts

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

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

Principal Display Panel - 4 g Tube Carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/31/2019

Labeler - Mineral Fusion brands (831770032)