MINERAL SPF 30 BRUSH-ON SUN DEFENSE- 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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide 24%

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 swallowed get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use water resistant sunscreen if swimming or sweating.
• Children under 6 months of age: Ask a doctor.
• Use: Remove cap and slide down brush sleeve. Tap brush gently against wrist until you see powder flow through the bristles. Brush generously onto skin.
• 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 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.

Other information

Protect this product in this container from excessive heat and direct sun.

Inactive ingredients

Mica, Silica, Lauroyl Lysine, Boron Nitride, Plankton Extract, Caprylic/Capric Triglyceride, Himanthalia Elongata Extract, Tocopherol, Glutamic Acid, Lysine HCl, Zinc PCA, Serine, Capryloyl Glycine, Sodium PCA, Undecylenoyl Glycine, Sodium Polyaspartate, Butylene Glycol, Arginine, Sodium Citrate, Aqua/Water/Eau, Betaine, Iron Oxides (CI 77491, CI 77492, CI 77499).

Questions?

Call toll free 1-800-428-1668

SPL UNCLASSIFIED SECTION

Dist. By Mineral Fusion, Petaluma, CA 94954 USA

PRINCIPAL DISPLAY PANEL - 4.0 g Tube Carton

Mineral SPF 30
Brush-On Sun Defense

Broad Spectrum SPF 30
Sunscreen Powder

MINERAL
FUSION®

Making Beauty Healthy®

Net Wt 0.14 oz / 4.0 g

INGREDIENTS AND APPEARANCE

MINERAL SPF 30 BRUSH-ON SUN DEFENSE 
zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55789-1501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Lauroyl Lysine (UNII: 113171Q70B)
Boron Nitride (UNII: 2U4T60A6YD)
ALARIA ESCULENTA (UNII: EJ9JK8J58D)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIMANTHALIA ELONGATA (UNII: 21RND18XRR)
TOCOPHEROL (UNII: R0ZB2556P8)
GLUTAMIC ACID (UNII: 3KX376GY7L)
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
ZINC PIDOLATE (UNII: C32PQ86DH4)
Serine (UNII: 452VLY9402)
Capryloyl Glycine (UNII: 8TY5YO42NJ)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
Undecylenoyl Glycine (UNII: 4D20464K2J)
Butylene Glycol (UNII: 3XUS85K0RA)
Arginine (UNII: 94ZLA3W45F)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
Water (UNII: 059QF0KO0R)
Betaine (UNII: 3SCV180C9W)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55789-1501-1	1 in 1 CARTON	04/29/2024
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 drug	M020	04/29/2024

Labeler - Mineral Fusion (831770032)