617bf6e8-2457-3fd7-e053-2991aa0aedda

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

Purpose

Sunscreen

Description

TITANIUM DIOXIDE 4.5% ZINC OXIDE 6.5%


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, 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.

Description

TITANIUM DIOXIDE 4.5% ZINC OXIDE 6.5%

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)

Do Not Use

on damaged or broken skin

Active Ingredients

TITANIUM DIOXIDE 4.5%

ZINC OXIDE 6.5%

Questions Or Comments?

Call 1-800-SAFESUN, Mon-Fri

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

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, 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.

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)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients

TITANIUM DIOXIDE 4.5%

ZINC OXIDE 6.5%

Questions Or Comments? (Questions or Comments?)

Call 1-800-SAFESUN, Mon-Fri

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

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