SPL v2
SPL
SPL Set ID 8b889b75-07ac-4276-e053-2a95a90a69c6
Route
TOPICAL
Published
Effective Date 2019-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (6 g) Octocrylene (2 g) Avobenzone
Inactive Ingredients
Isobutane .alpha.-tocopherol Acetate Caprylyl Glycol Butyloctyl Salicylate Alcohol Isododecane Diisopropyl Adipate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-06-17 Until 2026-12-01

Description

Avobenzone 2.0%, Homosalate 6.0%, Octocrylene 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.0%, Homosalate 6.0%, Octocrylene 6.0%

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

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. • 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

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 2.0%, Homosalate 6.0%, Octocrylene 6.0%

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Caprylyl Glycol, Butyloctyl Salicylate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Fragrance, Tocopheryl Acetate

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA BOAT®

NEW!

hair & scalp defense

CLEAN SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 30

30

Lightweight

Non-Greasy

PROTECTION FOR HAIR & SCALP

Won't Dry Out Hair

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 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 (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. • 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

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 2.0%, Homosalate 6.0%, Octocrylene 6.0%

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Caprylyl Glycol, Butyloctyl Salicylate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Fragrance, Tocopheryl Acetate

Questions Or Comments? (Questions or Comments?)

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA BOAT®

NEW!

hair & scalp defense

CLEAN SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 30

30

Lightweight

Non-Greasy

PROTECTION FOR HAIR & SCALP

Won't Dry Out Hair

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 Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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