BIG ISLAND BASICS- avobenzone, octinoxate, octisalate, octocrylene stick

Big Island Basics by

Drug Labeling and Warnings

Big Island Basics by is a Otc medication manufactured, distributed, or labeled by Raining Rose, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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

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INGREDIENTS AND APPEARANCE

BIG ISLAND BASICS 
avobenzone, octinoxate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-1005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	65 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	15 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
YELLOW WAX (UNII: 2ZA36H0S2V)
OLIVE OIL (UNII: 6UYK2W1W1E)
TOCOPHEROL (UNII: R0ZB2556P8)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
ROSEMARY (UNII: IJ67X351P9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SOYBEAN OIL (UNII: 241ATL177A)
SUNFLOWER OIL MONOGLYCERIDES (UNII: ZVW8EIZ3IE)
CANOLA OIL (UNII: 331KBJ17RK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-1005-1	17 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2020

Labeler - Raining Rose, Inc. (083819404)

Registrant - Raining Rose, Inc. (083819404)