SPL v6
SPL
SPL Set ID 76782de6-a542-6f3e-e053-2a91aa0a5afd
Route
TOPICAL
Published
Effective Date 2018-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (4.5 g) Octocrylene (6 g) Avobenzone (3 g) Homosalate (9 g)
Inactive Ingredients
Morella Cerifera Fruit Wax Phenoxyethanol Sodium Citrate Water Isobutane Ethylhexyl Methoxycrylene Isohexadecane Alkyl (c12-15) Benzoate Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Sodium Chloride Glycerin Caprylyl Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-10-15 Until 2026-10-01

Description

Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 6%

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.

Section 51945-4

BANANA

BOAT

Simply

Protect

KIDS

SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

25% FEWER INGREDIENTS

MADE WITHOUT OXYBENZONE & PARABENS

tear free

No Added Oils & Fragrances

Water Resistant

(80 Minutes)

SHAKE WELL BEFORE USE

Warnings

For external use only.

Flammable

Contents under pressure. Do not puncture or incinerate container. 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 spread evenly by hand 15 minutes before sun exposure. Do not spray directly into face. Spray on hands and then apply to face. Do not apply in windy conditions. Use in a 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. 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

Do Not Use

on damaged or broken skin.

Active Ingredient

Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 6%

Other Information

protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Isobutane, Isohexadecane, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, Myrica Cerifera (Bayberry) Fruit Wax, Ethylhexyl Methoxycrylene, Sodium Chloride, Glycerin, Phenoxyethanol, Caprylyl Glycol, Sodium Citrate.

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

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.

Section 51945-4 (51945-4)

BANANA

BOAT

Simply

Protect

KIDS

SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

25% FEWER INGREDIENTS

MADE WITHOUT OXYBENZONE & PARABENS

tear free

No Added Oils & Fragrances

Water Resistant

(80 Minutes)

SHAKE WELL BEFORE USE

Purpose

Sunscreen

Warnings

For external use only.

Flammable

Contents under pressure. Do not puncture or incinerate container. 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 (May stain)

some fabrics.

Directions

Shake well. 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 and then apply to face. Do not apply in windy conditions. Use in a 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. 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

Do Not Use (Do not use)

on damaged or broken skin.

Active Ingredient

Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 6%

Other Information

protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Isobutane, Isohexadecane, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, Myrica Cerifera (Bayberry) Fruit Wax, Ethylhexyl Methoxycrylene, Sodium Chloride, Glycerin, Phenoxyethanol, Caprylyl Glycol, Sodium Citrate.

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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