dc79790f-e2bc-5414-e053-2a95a90a9e7a

SPL v3
SPL
SPL Set ID dc79790f-e2bc-5414-e053-2a95a90a9e7a
Route
topical
Published
Effective Date 2022-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (6.5 g) titanium dioxide (4.5 g)
Inactive Ingredients
.alpha.-tocopherol acetate cetyl peg/ppg-10/1 dimethicone (hlb 2) aluminum oxide isohexadecane medium-chain triglycerides butyloctyl salicylate ethylhexyl methoxycrylene dimethicone phenoxyethanol glycerin anhydrous trisodium citrate water caprylyl glycol sodium chloride

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2022-04-12 Until 2026-12-01

Purpose

Sunscreen

Description

Titanium Dioxide 4.5%, Zinc Oxide 6.5%.


Medication Information

Warnings

For external use only.

May stain some fabrics.

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

Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply: after 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
  • 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
  • Children under 6 months: Ask a doctor
Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Octyldodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Sodium Chloride, Ethylhexyl Methoxycrylene, Dimethicone, Phenoxyethanol, Caprylyl Glycol, PEG-8, Alumina, Glycerin, Sodium Citrate, Tocopheryl Acetate.

Description

Titanium Dioxide 4.5%, Zinc Oxide 6.5%.

Principal Display Panel

BANANA

BOAT®

Sport

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

HIGH ENDURANCE VS. SWEAT

CLINICALLY TESTED

NO OXYBENZONE & PARABENS

Water Resistant

(80 Minutes)

6 FL. OZ. (177 mL)

50%

MORE

FAMILY SIZE!

9 OZ VS 6 OZ

BANANA

BOAT

Sport

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

HIGH ENDURANCE VS. SWEAT

CLINICALLY TESTED

NO OXYBENZONE & PARABENS

Water Resistant

(80 Minutes)

6 FL. OZ. (177 mL)

Do Not Use

on damaged or broken skin.

Active Ingredients

Titanium Dioxide 4.5%, Zinc Oxide 6.5%.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

When Using This Product

• 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

Warnings

For external use only.

May stain some fabrics.

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

Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply: after 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
  • 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
  • Children under 6 months: Ask a doctor
Other Information (Other information)

Protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Octyldodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Sodium Chloride, Ethylhexyl Methoxycrylene, Dimethicone, Phenoxyethanol, Caprylyl Glycol, PEG-8, Alumina, Glycerin, Sodium Citrate, Tocopheryl Acetate.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

BANANA

BOAT®

Sport

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

HIGH ENDURANCE VS. SWEAT

CLINICALLY TESTED

NO OXYBENZONE & PARABENS

Water Resistant

(80 Minutes)

6 FL. OZ. (177 mL)

50%

MORE

FAMILY SIZE!

9 OZ VS 6 OZ

BANANA

BOAT

Sport

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

HIGH ENDURANCE VS. SWEAT

CLINICALLY TESTED

NO OXYBENZONE & PARABENS

Water Resistant

(80 Minutes)

6 FL. OZ. (177 mL)

Do Not Use (Do not use)

on damaged or broken skin.

Active Ingredients

Titanium Dioxide 4.5%, Zinc Oxide 6.5%.

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

When Using This Product (When using this product)

• 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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