dc783438-b28f-b7f4-e053-2a95a90a3d65

SPL v3
SPL
SPL Set ID dc783438-b28f-b7f4-e053-2a95a90a3d65
Route
topical
Published
Effective Date 2022-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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

Shake well • 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®

sensitive

mineral

faces

100% MINERAL BASES SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

HYPOALLERGENIC

OIL FREE-LIGHTWEIGHT FEEL

NO OXYBENZONE & PARABENS

Water Resistant

(80 Minutes)

3 FL OZ. (88 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

Shake well • 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®

sensitive

mineral

faces

100% MINERAL BASES SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

HYPOALLERGENIC

OIL FREE-LIGHTWEIGHT FEEL

NO OXYBENZONE & PARABENS

Water Resistant

(80 Minutes)

3 FL OZ. (88 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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