BRUSH ON BLOCK MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide 15%, zinc oxide 12% cream

Brush on Block Mineral Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Brush on Block Mineral Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by SPF Ventures, LLC, Hudson Cosmetics Manufacturing Corp. DBA Paramount Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Titanium Dioxide 15%

Zinc Oxide 12%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases risk of skin cancer and early skin aging caused by the sun

DOSAGE & ADMINISTRATION

Directions

• apply liberally 15 minutes before sun exposure
• reapply: after 80 minutes of swimming or sweating, immediately after towel drying, and 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 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. and wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

WARNINGS

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

Keep out of reach of children.  If product is swallowed, get medical help or contact a Poison Control Center right away

QUESTIONS

Questions or Comments?

Call toll free 1-800-916-7690

OTHER SAFETY INFORMATION

Other Information

• protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

Brush on Block

Mineral Sunscreen

Broad Spectrum SPF 30

UVA/UVB Protection

Water Resistant (80 MIN)

NET WT 3.4 G/.12 OZ

BRUSHONBLOCK.COM

INGREDIENTS AND APPEARANCE

BRUSH ON BLOCK MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
titanium dioxide 15%, zinc oxide 12% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58274-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	15 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	12 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
BORON NITRIDE (UNII: 2U4T60A6YD)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
STARCH, RICE (UNII: 4DGK8B7I3S)
SAFFLOWER OIL (UNII: 65UEH262IS)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
RICE BRAN (UNII: R60QEP13IC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58274-006-01	3.4 g 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 not final	part352	04/19/2013

Labeler - SPF Ventures, LLC (055483891)

Establishment
Name	Address	ID/FEI	Business Operations
Hudson Cosmetics Manufacturing Corp. DBA Paramount Cosmetics		001321058	manufacture(58274-006)