BRUSH ON BLOCK MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide and zinc oxide cream
SPF Ventures, LLC

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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Drug Facts

Active Ingredients

Titanium Dioxide 15%

Zinc Oxide 12%

Purpose

Sunscreen

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

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

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

Questions or Comments?

Call toll free 1-800-916-7690

Other Information

protect this product from excessive heat and direct sun

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

image description

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	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	15 g in 100 g
ZINC OXIDE (ZINC CATION)	ZINC CATION	12 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE
BORON NITRIDE
CHAMAEMELUM NOBILE FLOWER
GREEN TEA LEAF
LONICERA JAPONICA FLOWER
LONICERA CAPRIFOLIUM FLOWER
FERRIC OXIDE RED
MICA
STARCH, RICE
SAFFLOWER OIL
SILICON DIOXIDE
STEARIC ACID
TRIETHOXYCAPRYLYLSILANE
RICE BRAN

Packaging
#	Item Code	Package Description
1	NDC:58274-006-01	3.4 g in 1 TUBE

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
Oxygen Development LLC		137098492	manufacture(58274-006)

Revised: 04/2013

Document Id: 19cce30b-5ae0-40d3-b4d9-ba7f25ef101b

Set id: 8b3e7a02-8822-4925-b011-1d45f4a3540e

Version: 1

Effective Time: 20130418

SPF Ventures, LLC