SPL v3
SPL
SPL Set ID dc7701b5-0c73-b4df-e053-2a95a90a0f1b
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
Medium-chain Triglycerides Sodium Chloride Alpha-tocopherol Acetate Butyloctyl Salicylate Water Isohexadecane Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Aluminum Oxide Ethylhexyl Methoxycrylene Caprylyl Glycol Glycerin Anhydrous Trisodium Citrate Dimethicone Phenoxyethanol

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®

KIDS

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PEDIATRICIAN TESTED

tear free

NO OXYBENZONE & PARABENS

Water Resistant

(80 Minutes)

1 FL.OZ.(29 mL)

BANANA

BOAT®

KIDS

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PEDIATRICIAN TESTED

tear free

NO OXYBENZONE & PARABENS

Water Resistant

(80 Minutes)

6 FL.OZ.(177 mL)

50%

MORE

FAMILY SIZE !

9 OZ VS 6 0Z

BANANA

BOAT®

KIDS

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PEDIATRICIAN TESTED

tear free

NO OXYBENZONE & PARABENS

Water Resistant

(80 Minutes)

9 FL.OZ.(266 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®

KIDS

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PEDIATRICIAN TESTED

tear free

NO OXYBENZONE & PARABENS

Water Resistant

(80 Minutes)

1 FL.OZ.(29 mL)

BANANA

BOAT®

KIDS

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PEDIATRICIAN TESTED

tear free

NO OXYBENZONE & PARABENS

Water Resistant

(80 Minutes)

6 FL.OZ.(177 mL)

50%

MORE

FAMILY SIZE !

9 OZ VS 6 0Z

BANANA

BOAT®

KIDS

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PEDIATRICIAN TESTED

tear free

NO OXYBENZONE & PARABENS

Water Resistant

(80 Minutes)

9 FL.OZ.(266 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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