SPL v5
SPL
SPL Set ID 47ded2d1-f057-28d1-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2014-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (3.2 g) Octocrylene (2.4 g) Homosalate (4.5 g) Avobenzone (3 g)
Inactive Ingredients
Mineral Oil Caprylyl Glycol Diethylhexyl 2,6-naphthalate Isopropyl Myristate Coconut Oil Grape Seed Oil Theobroma Cacao Whole .alpha.-tocopherol Acetate Aloe Vera Leaf Sunflower Oil Corn Oil Carrot Banana Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-01-01

Description

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 2.4%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 2.4%

Uses

Helps prevent sunburn

Section 51945-4

BANANA

BOAT®

PROTECTIVE

SPRAY OIL

SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 15

15

WITH COCONUT OIL

Skin Nourishing Formula

Water Resistant

(80 Minutes)

8 FL. OZ. (236 mL)

Warnings

For external use only

May stain some fabrics

Directions

• apply liberally 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 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 • children under 6 months: Ask a doctor

Do Not Use

on damaged or broken skin

Other Information

protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 2.4%

Inactive Ingredients

Mineral Oil, C12-15 Alkyl Benzoate, Caprylyl Glycol, Diethylhexyl 2,6-Naphthalate, Isopropyl Myristate, Coconut Oil, Grape Seed Oil, Theobroma Cacao (Cocoa) Seed Butter (Cocoa Butter),Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Zea Mays (Corn) Oil, Aloe Barbadensis Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract, Musa Sapientum (Banana) Fruit Extract,Phenoxyethanol, Fragrance.

Questions & Comments?

Call 1-800-SafeSun, mon-fri

When Using This Product

Keep out of eyes. Rinse with water to remove

Stop Use and Ask A Doctor

if rash occurs

Keep Out of Reach of Children

If product is swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

Helps prevent sunburn

Section 51945-4 (51945-4)

BANANA

BOAT®

PROTECTIVE

SPRAY OIL

SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 15

15

WITH COCONUT OIL

Skin Nourishing Formula

Water Resistant

(80 Minutes)

8 FL. OZ. (236 mL)

Purpose

Sunscreen

Warnings

For external use only

May stain some fabrics

Directions

• apply liberally 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 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 • children under 6 months: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

Other Information

protect this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 2.4%

Inactive Ingredients (Inactive ingredients)

Mineral Oil, C12-15 Alkyl Benzoate, Caprylyl Glycol, Diethylhexyl 2,6-Naphthalate, Isopropyl Myristate, Coconut Oil, Grape Seed Oil, Theobroma Cacao (Cocoa) Seed Butter (Cocoa Butter),Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Zea Mays (Corn) Oil, Aloe Barbadensis Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract, Musa Sapientum (Banana) Fruit Extract,Phenoxyethanol, Fragrance.

Questions & Comments? (Questions & comments?)

Call 1-800-SafeSun, mon-fri

When Using This Product (When using this product)

Keep out of eyes. Rinse with water to remove

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

Keep Out of Reach of Children (Keep out of reach of children)

If product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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