SUNBLOCZ- zinc oxide cream

Sunblocz by

Drug Labeling and Warnings

Sunblocz by is a Otc medication manufactured, distributed, or labeled by Olen Cosmetics Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Zinc Oxide 24.5%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

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

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• Apply liberally and evenly 15 minutes before sun exposure
• Reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• 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 a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. -2 p.m.
• wear long-sleeve shirts, pants, hats and sunglasses
• Children under 6 months: Ask a doctor

STORAGE AND HANDLING

Other information

• Protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients

Grape Seed Oil, Safflower Oil, Beeswax, Candelilla wax, Rice Bran Wax, Green Tea, Iron Oxide, Lavender Essential Oil, Rosemary Essential Oil.

QUESTIONS

Questions or comments?

www.olencosmetics.com or call toll free 1-877-494-4313

SPL UNCLASSIFIED SECTION

Manufactured for:

Olen Cosmetics Corporation

31 Woodstone Drive

East St. Paul, Manitoba

Canada, R2EOM5

Made in Canada

PRINCIPAL DISPLAY PANEL

Sunblocz

100% NATURAL

ZINC OXIDE SUNSCREEN CREAM

NATURALLY TINTED

BROAD SPECTRUM SPF 50

UVA & UVB

Water Resistant (80 minutes)

Dermatologist Recommended

Clinically Tested

Hypoallergenic

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

SUNBLOCZ 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52358-0004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	43.4 g  in 177 mL

Inactive Ingredients
Ingredient Name	Strength
LAVENDER OIL (UNII: ZBP1YXW0H8)
ROSEMARY OIL (UNII: 8LGU7VM393)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
CANDELILLA WAX (UNII: WL0328HX19)
SAFFLOWER OIL (UNII: 65UEH262IS)
YELLOW WAX (UNII: 2ZA36H0S2V)
RICE BRAN (UNII: R60QEP13IC)
GRAPE SEED OIL (UNII: 930MLC8XGG)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52358-0004-1	177 mL in 1 TUBE; Type 0: Not a Combination Product	06/21/2016	06/12/2018
2	NDC: 52358-0004-2	118 mL in 1 TUBE; Type 0: Not a Combination Product	06/07/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/21/2016

Labeler - Olen Cosmetics Corporation (250916611)