2b0f8a36-b617-90b4-e063-6394a90a665f

SPL v1
SPL
SPL Set ID 2b0f8a36-b617-90b4-e063-6394a90a665f
Route
topical
Published
Effective Date 2024-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (3.5 g) zinc oxide (9.3 g)
Inactive Ingredients
peg-8 glycerin caprylic/capric triglyceride sodium citrate cetyl peg/ppg-10/1 dimethicone (hlb 2) lauryl peg-8 dimethicone (300 cps) caprylyl glycol alumina butyloctyl salicylate dimethicone isohexadecane sodium chloride triethoxycaprylylsilane water ethylhexyl methoxycrylene phenoxyethanol .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-07-01

Purpose

Sunscreen

Description

Titanium Dioxide 2.8%, Zinc Oxide 9.3%


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

Description

Titanium Dioxide 2.8%, Zinc Oxide 9.3%

Principal Display Panel

BANANA BOAT

KIDS

Mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PEDIATRICIAN TESTED

tear free

MADE WITHOUT OXYBENZONE & PARABENS

Water Resistant

(80 Minutes)

6 FL. OZ. (177 mL)

Do Not Use

on damaged or broken skin.

Active Ingredients

Titanium Dioxide 2.8%, Zinc Oxide 9.3%

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

Principal Display Panel

BANANA BOAT

KIDS

Mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PEDIATRICIAN TESTED

tear free

MADE WITHOUT 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 2.8%, Zinc Oxide 9.3%

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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