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

Description

Titanium Dioxide 4.5%, Zinc Oxide 6.5%.

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 4.5%, Zinc Oxide 6.5%.

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.

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

Do Not Use

on damaged or broken skin.

Other Information

Protect this product from excessive heat and direct sun

Active Ingredients

Titanium Dioxide 4.5%, Zinc Oxide 6.5%.

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.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

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)

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

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.

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

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

Titanium Dioxide 4.5%, Zinc Oxide 6.5%.

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.

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

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)

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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