0fc83618-9a6d-5ad1-e054-00144ff88e88

SPL v7
SPL
SPL Set ID 0fc83618-9a6d-5ad1-e054-00144ff88e88
Route
topical
Published
Effective Date 2015-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (7 g) octocrylene (5 g) avobenzone (2 g)
Inactive Ingredients
argan oil panthenol water diisopropyl adipate ascorbyl palmitate methyl dihydroabietate aloe vera leaf mineral oil alcohol isobutane isododecane caprylyl glycol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2015-02-23

Purpose

Sunscreen

Description

Avobenzone 2.0%, Homosalate 7.0%, Octocrylene 5.0%


Medication Information

Warnings

For external use only.

Flammable: Do not puncture or incinerate. Contents under pressure. Do not expose to heat or store at temperatures above 120F. 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.

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

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. 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.

Other Information

protect this product from excessive heat and direct sun

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.

Description

Avobenzone 2.0%, Homosalate 7.0%, Octocrylene 5.0%

Section 51945-4

BANANA

BOAT®

PROTECTIVE

DRY OIL

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 25

25

WITH

COCONUT OIL

MOISTURIZES

SKIN

Lightweight, Non-greasy

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 g)

Do Not Use

on damaged or broken skin.

Active Ingredients

Avobenzone 2.0%, Homosalate 7.0%, Octocrylene 5.0%

Questions Or Comments?

Call 1 800 SafeSun, Mon-Fri

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

Warnings

For external use only.

Flammable: Do not puncture or incinerate. Contents under pressure. Do not expose to heat or store at temperatures above 120F. 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.

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

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. 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.

Other Information

protect this product from excessive heat and direct sun

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.

Section 51945-4 (51945-4)

BANANA

BOAT®

PROTECTIVE

DRY OIL

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 25

25

WITH

COCONUT OIL

MOISTURIZES

SKIN

Lightweight, Non-greasy

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 g)

Do Not Use (Do not use)

on damaged or broken skin.

Active Ingredients

Avobenzone 2.0%, Homosalate 7.0%, Octocrylene 5.0%

Questions Or Comments? (Questions or comments?)

Call 1 800 SafeSun, Mon-Fri

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.


Advanced Ingredient Data


Raw Label Data

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