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

Description

Titanium Dioxide 2.8%, Zinc Oxide 9.3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 2.8%, Zinc Oxide 9.3%

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 2.8%, Zinc Oxide 9.3%

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.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

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)

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 2.8%, Zinc Oxide 9.3%

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.

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

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)

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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