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  5. Label Information: Big Island Basics

FDA Label for Big Island Basics

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. DOSAGE & ADMINISTRATION
    7. INACTIVE INGREDIENT
    8. OTHER SAFETY INFORMATION
    9. PRINCIPAL DISPLAY PACKAGE

Big Island Basics Product Label

The following document was submitted to the FDA by the labeler of this product Raining Rose, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Active Ingredient



Active Ingredients
Avobenzone    2.0%
Octinoxate      6.5%
Octisalate       5.0%
Octocrylene    1.5%


Otc - Purpose



Purpose

Avobenzone      Sunscreen
Octinoxate        Sunscreen
Octisalate         Sunscreen
Octocrylene      Sunscreen


Indications & Usage



Uses • Helps prevent sunburn


Warnings



Warnings
For external use only • Do not use on damaged or broken skin.
Stop use and ask a doctor if rash occurs. When using this
product keep out of eyes.  Rinse with water to remove.
Keep out of reach of children. If swallowed get medical help
or contact Poison Control Center right away. For children
under 6 months of age ask a doctor before use.


Dosage & Administration



Directions

•Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating

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


Inactive Ingredient



Inactive Ingredients
Sunflower Oil*, Beeswax, Extra Virgin Olive Oil*, Flavor, Tocopherol,
Hemp Seed Oil*, Rosemary Leaf Extract, Aloe Vera Leaf Extract, Soybean
Oil, Sunflower Seed Oil Glycerides, Canola Oil, *Certified Organic


Other Safety Information



Other Information: Protect this product from excessive
heat and sun.


Principal Display Package



BIG
ISLAND
BASICS

LIP
BALM

VINTAGE PARADISE

NET WT .60 OZ/17G

For external use only

Broad Spectrum SPF 15 Sunscreen
Lip Balm

Made for Zodax, Panorama City, CA 91402

Distributed by Tommy Bahana Group, Inc. Seattle, WA 98109

L341677

res


* Please review the disclaimer below.