SPL v5
SPL
SPL Set ID 617bf6e8-2457-3fd7-e053-2991aa0aedda
Route
TOPICAL
Published
Effective Date 2018-01-02
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
Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Sodium Citrate Aluminum Oxide Butyloctyl Salicylate Ethylhexyl Methoxycrylene Polyethylene Glycol 400 Medium-chain Triglycerides Glycerin Sodium Chloride .alpha.-tocopherol Acetate, Dl- Isohexadecane Water Phenoxyethanol Caprylyl Glycol Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-01-02 Until 2026-06-01

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®

baby

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)

When Using This Product

• keep out of eyes. Keep away from face to avoid breathing it. 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

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

BANANA

BOAT®

baby

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)

When Using This Product (When using this product)

• keep out of eyes. Keep away from face to avoid breathing it. 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

All Sections (JSON)