Other
Drug Facts
Manufactured for:
Olen Cosmetics Corporation
31 Woodstone Drive
East St. Paul, Manitoba
Canada, R2EOM5
Made in Canada
Sunblocz Cream
FDA Label NDC 52358-0004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Olen Skin Care Corporation for the product Sunblocz (NDC 52358-0004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Zinc Oxide 24.5%
Otc - 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
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - 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.
Otc - Questions
Questions or comments?
www.olencosmetics.com or call toll free 1-877-494-4313
Package Label.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)
Sunblocz (Sunblocz)
* Please review the disclaimer below.
