SPL v1
SPL
SPL Set ID 1ba57692-c36d-ef4a-e063-6394a90a1236
Route
TOPICAL
Published
Effective Date 2023-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (22.5 g)
Inactive Ingredients
Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Stearyl/octyldodecyl Citrate Crosspolymer Sodium Citrate Water Polyhydroxystearic Acid (2300 Mw) Triethoxycaprylylsilane Isobutane Butyloctyl Salicylate Phenoxyethanol Medium-chain Triglycerides Isododecane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-27

Description

Zinc Oxide 22.5%

Purpose

Sunscreen Agent


Medication Information

Purpose

Sunscreen Agent

Description

Zinc Oxide 22.5%

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.

Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120 °F.

Flammable: Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

Directions

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.

Other Information

• protect this product from excessive heat and direct sun

Active Ingredients

Zinc Oxide 22.5%

Inactive Ingredients:

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

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA BOAT(R)

SPORT

mineral

100% MINERAL BASED SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50

50

HIGH ENDURANCE VS. SWEAT

CLINICALLY TESTED

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

NET WT 5 OZ. (141 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 Agent

Warnings

For external use only.

May stain some fabrics.

Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120 °F.

Flammable: Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

Directions

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.

Other Information

• protect this product from excessive heat and direct sun

Active Ingredients

Zinc Oxide 22.5%

Inactive Ingredients:

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

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA BOAT(R)

SPORT

mineral

100% MINERAL BASED SUNSCREEN LOTION SPRAY

UVA/UVB BROAD SPECTRUM SPF 50

50

HIGH ENDURANCE VS. SWEAT

CLINICALLY TESTED

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

NET WT 5 OZ. (141 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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