Big Island Basics Lip Balm Spf 15 Sunscreen

Big Island Basics Lip Balm Spf 15 Sunscreen
SPL v1
SPL
SPL Set ID 07b5cec6-3bf9-48ba-a945-5c560e7535dd
Route
TOPICAL
Published
Effective Date 2020-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (20 mg) Octinoxate (65 mg) Octisalate (50 mg) Octocrylene (15 mg)
Inactive Ingredients
Sunflower Oil Yellow Wax Olive Oil Tocopherol Cannabis Sativa Seed Oil Rosemary Aloe Vera Leaf Soybean Oil Sunflower Oil Monoglycerides Canola Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-04-01

Description

Drug Facts


Medication Information

Warnings and Precautions

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.

Indications and Usage

Uses • Helps prevent sunburn

Dosage and 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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 51727-6

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

Section 55105-1

Purpose

Avobenzone      Sunscreen

Octinoxate        Sunscreen

Octisalate         Sunscreen

Octocrylene      Sunscreen

Section 55106-9

Active Ingredients

Avobenzone    2.0%

Octinoxate      6.5%

Octisalate       5.0%

Octocrylene    1.5%

Section 60561-8

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


Structured Label Content

Indications and Usage (34067-9)

Uses • Helps prevent sunburn

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

Drug Facts

Section 51727-6 (51727-6)

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

Section 55105-1 (55105-1)

Purpose

Avobenzone      Sunscreen

Octinoxate        Sunscreen

Octisalate         Sunscreen

Octocrylene      Sunscreen

Section 55106-9 (55106-9)

Active Ingredients

Avobenzone    2.0%

Octinoxate      6.5%

Octisalate       5.0%

Octocrylene    1.5%

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)