SPL v5
SPL
SPL Set ID 92fdea59-c19d-627a-e053-2995a90aabdc
Route
TOPICAL
Published
Effective Date 2019-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (7.3 g) Homosalate (9 g) Octisalate (3 g) Octocrylene (6 g)
Inactive Ingredients
Water Isododecane Anhydrous Trisodium Citrate Triethoxycaprylylsilane Polyhydroxystearic Acid (2300 Mw) Phenoxyethanol Butyloctyl Salicylate Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Isobutane Medium-chain Triglycerides

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-09-23 Until 2024-12-01

Description

Homosalate 9.0%, Octisalate 3.0%, Octocrylene 6.0%, Zinc Oxide 7.3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 9.0%, Octisalate 3.0%, Octocrylene 6.0%, Zinc Oxide 7.3%

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.

May stain some fabrics.

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.

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 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.

Other Information

protect this product from excessive heat and direct sun

Active Ingredients

Homosalate 9.0%, Octisalate 3.0%, Octocrylene 6.0%, Zinc Oxide 7.3%

Inactive Ingredients

Water, Isobutane, Isododecane, Cetyl PEG/PPG-10/1 Dimethicone, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Phenoxyethanol, Polyhydroxystearic acid, Triethoxycaprylylsilane, Sodium Citrate.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA

BOAT®

sensitive

mineral

enriched

MINERAL ENRICHED SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

HYPOALLERGENIC

WITH NATURALLY SOURCED ZINC

NO OXYBENZONE & PARABENS

Water Resistant

(80 Minutes)

SHAKE WELL BEFORE USE

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 removed.

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.

May stain some fabrics.

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.

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 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.

Other Information (Other information)

protect this product from excessive heat and direct sun

Active Ingredients

Homosalate 9.0%, Octisalate 3.0%, Octocrylene 6.0%, Zinc Oxide 7.3%

Inactive Ingredients (Inactive ingredients)

Water, Isobutane, Isododecane, Cetyl PEG/PPG-10/1 Dimethicone, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Phenoxyethanol, Polyhydroxystearic acid, Triethoxycaprylylsilane, Sodium Citrate.

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA

BOAT®

sensitive

mineral

enriched

MINERAL ENRICHED SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

HYPOALLERGENIC

WITH NATURALLY SOURCED ZINC

NO OXYBENZONE & PARABENS

Water Resistant

(80 Minutes)

SHAKE WELL BEFORE USE

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 removed.

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

All Sections (JSON)