SPL v1
SPL
SPL Set ID 0ad8187d-43a3-933b-e063-6294a90a20c4
Route
TOPICAL
Published
Effective Date 2020-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-30

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.

Section 51945-4

BANANA

BOAT®

baby

mineral

enriched

MINERAL ENRICHED‡ SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PEDIATRICIAN TESTED

Won't Run Into Eyes

NO OXYBENZONE & PARABENS

Water Resistant

(80 Minutes)

SHAKE WELL BEFORE USE

NET WT 6 OZ. (170 g)

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 from10 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

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®

baby

mineral

enriched

MINERAL ENRICHED‡ SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PEDIATRICIAN TESTED

Won't Run Into Eyes

NO OXYBENZONE & PARABENS

Water Resistant

(80 Minutes)

SHAKE WELL BEFORE USE

NET WT 6 OZ. (170 g)

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 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 from10 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

• 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? (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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