SPL v9
SPL
SPL Set ID 0fda2f46-4322-1284-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2015-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (3.5 g) Avobenzone (1.5 g) Homosalate (5 g)
Inactive Ingredients
Coconut Oil Black Olive Argan Oil Ascorbyl Palmitate Panthenol Water Alcohol Isobutane Isododecane Diisopropyl Adipate Mineral Oil Caprylyl Glycol Aloe Vera Leaf Methyl Dihydroabietate Grape Seed Oil Lauryl Peg-8 Dimethicone (300 Cps) Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-02-24 Until 2017-12-01

Description

Avobenzone 1.5%, Homosalate 5.0%, Octocrylene 3.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 1.5%, Homosalate 5.0%, Octocrylene 3.5%

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

For external use only.

Flammable: Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F. Do not use in the presence of a flame or spark. Keep away from sources of ignition – No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

May stain some fabrics.

Directions

hold container 4 to 6 inches from the skin to apply. spray liberally and spread evenly by hand 15 minutes before sun exposure. do not spray directly into face. Spray on hands then apply to face. do not apply in windy conditions. use in well-ventilated area. 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 caused by the sun. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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 1.5%, Homosalate 5.0%, Octocrylene 3.5%

Inactive Ingredients

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Mineral Oil, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Caprylyl Glycol, Methyl Dihydroabietate, Fragrance, Argania Spinosa Kernel Oil, Ascorbyl Palmitate, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Panthenol, Water, Aloe Barbadensis Leaf Extract.

Questions Or Comments?

Call 1 800 SafeSun, Mon-Fri

Principal Display Panel

BANANA

BOAT(R)

PROTECTIVE

DRY OIL

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 15

WITH

COCONUT OIL

MOISTURIZES

SKIN

Lightweight, Non-greasy

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 g)

55 %

MORE

FAMILY SIZE!

9.5 OZ VS 6 OZ

BANANA

BOAT(R)

PROTECTIVE

DRY OIL

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 15

WITH

COCONUT OIL

MOISTURIZES

SKIN

Lightweight, Non-greasy

Water Resistant

(80 Minutes)

NET WT 9.5 OZ. (269 g)

When Using This Product

Keep away from face to avoid breathing it • 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. 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.

Purpose

Sunscreen

Warnings

For external use only.

Flammable: Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F. Do not use in the presence of a flame or spark. Keep away from sources of ignition – No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

May stain some fabrics.

Directions

hold container 4 to 6 inches from the skin to apply. spray liberally and spread evenly by hand 15 minutes before sun exposure. do not spray directly into face. Spray on hands then apply to face. do not apply in windy conditions. use in well-ventilated area. 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 caused by the sun. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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

Avobenzone 1.5%, Homosalate 5.0%, Octocrylene 3.5%

Inactive Ingredients (Inactive ingredients)

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Mineral Oil, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Caprylyl Glycol, Methyl Dihydroabietate, Fragrance, Argania Spinosa Kernel Oil, Ascorbyl Palmitate, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Panthenol, Water, Aloe Barbadensis Leaf Extract.

Questions Or Comments? (Questions or comments?)

Call 1 800 SafeSun, Mon-Fri

Principal Display Panel

BANANA

BOAT(R)

PROTECTIVE

DRY OIL

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 15

WITH

COCONUT OIL

MOISTURIZES

SKIN

Lightweight, Non-greasy

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 g)

55 %

MORE

FAMILY SIZE!

9.5 OZ VS 6 OZ

BANANA

BOAT(R)

PROTECTIVE

DRY OIL

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 15

WITH

COCONUT OIL

MOISTURIZES

SKIN

Lightweight, Non-greasy

Water Resistant

(80 Minutes)

NET WT 9.5 OZ. (269 g)

When Using This Product (When using this product)

Keep away from face to avoid breathing it • 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.


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Raw Label Data

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