SPL v8
SPL
SPL Set ID 0fd8448c-5b3a-1a76-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2015-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (1 g) Homosalate (3 g) Octocrylene (2 g)
Inactive Ingredients
Mineral Oil Methyl Dihydroabietate Water Aloe Vera Leaf Alcohol Isobutane Isododecane Diisopropyl Adipate Panthenol Argan Oil

Identifiers & Packaging

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

Description

Avobenzone 1.0%, Homosalate 3.0%, Octocrylene 2.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 1.0%, Homosalate 3.0%, Octocrylene 2.0%

Uses

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. For external use only.

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 • 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 1.0%, Homosalate 3.0%, Octocrylene 2.0%

Inactive Ingredients

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Mineral Oil, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Methyl Dihydroabietate, Caprylyl Glycol, 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®

TANNING

DRY OIL

CLEAR SUNSCREEN SPRAY SPF 8

8

WITH

COCONUT OIL

MOISTURIZES

SKIN

Lightweight, Non-greasy

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 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 Posion Control Center right away.


Structured Label Content

Uses

helps prevent sunburn

Purpose

Sunscreen

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. For external use only.

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 • 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 1.0%, Homosalate 3.0%, Octocrylene 2.0%

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, Methyl Dihydroabietate, Caprylyl Glycol, 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®

TANNING

DRY OIL

CLEAR SUNSCREEN SPRAY SPF 8

8

WITH

COCONUT OIL

MOISTURIZES

SKIN

Lightweight, Non-greasy

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 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 Posion Control Center right away.


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Raw Label Data

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