SPL v7
SPL
SPL Set ID 0c238393-1035-19aa-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2015-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 g) Octocrylene (6 g) Avobenzone (3 g) Homosalate (10 g)
Inactive Ingredients
Aloe Vera Leaf Dimethyl Ether Ethylhexyl Palmitate Isohexadecane Caprylyl Glycol Hydrogenated Methyl Abietate Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-01-08

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 6.0%

Uses

• helps prevent sunburn • If used as directed with other sun protectiion 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

Shake well • hold container 4 to 6 inches from the skin to apply • spray liberally and 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 minues 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-sleeve 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 10.0%, Octisalate 5.0%, Octocrylene 6.0%

Inactive Ingrdients

Ethylhexyl Palmitate, Dimethyl Ether, Isohexadecane, Caprylyl Glycol, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Methyl Dihydroabietate, Tocopheryl Acetate, Mineral Oil, Aloe Barbadensis Leaf Extract.

Questions Or Comments?

• protect this product from excessive heat and direct sun

Principal Display Panel

BANANA

BOAT®

KiDS

free

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

ALCOHOL FREE

CLEAR SPRAY

tear+sting free

High Endurance vs. Water

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 g)

When Using This Product

• keep away from face to avoid beathing 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 protectiion 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

Shake well • hold container 4 to 6 inches from the skin to apply • spray liberally and 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 minues 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-sleeve 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 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 6.0%

Inactive Ingrdients

Ethylhexyl Palmitate, Dimethyl Ether, Isohexadecane, Caprylyl Glycol, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Methyl Dihydroabietate, Tocopheryl Acetate, Mineral Oil, Aloe Barbadensis Leaf Extract.

Questions Or Comments? (Questions or comments?)

• protect this product from excessive heat and direct sun

Principal Display Panel

BANANA

BOAT®

KiDS

free

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

ALCOHOL FREE

CLEAR SPRAY

tear+sting free

High Endurance vs. Water

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 g)

When Using This Product (When using this product)

• keep away from face to avoid beathing 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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