9751a700-5d51-357b-e053-2a95a90af66c

SPL v5
SPL
SPL Set ID 9751a700-5d51-357b-e053-2a95a90af66c
Route
topical
Published
Effective Date 2019-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (2 g) octisalate (4.5 g) octocrylene (3 g) homosalate
Inactive Ingredients
glyceryl 1-stearate cetyl alcohol alpha-tocopherol acetate cetyl dimethicone 150 vinylpyrrolidone/eicosene copolymer chlorphenesin xanthan gum docosanol edetate disodium anhydrous sodium polyacrylate (2500000 mw) aloe vera leaf propylene glycol phenoxyethanol caprylyl glycol water polyoxyl 100 stearate

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2019-11-14 Until 2026-12-01

Purpose

Sunscreen

Description

Avobenzone 2.0%, Homosalate 3.0%, Octisalate 4.5%, Octocrylene 3.0%


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

• 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 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, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Cetyl Dimethicone, Propylene Glycol, Phenoxyethanol, Caprylyl Glycol, VP/Eicosene Copolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Behenyl Alcohol, Sodium Polyacrylate, Chlorphenesin, Xanthan Gum, Disodium EDTA, Fragrance, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice

Description

Avobenzone 2.0%, Homosalate 3.0%, Octisalate 4.5%, Octocrylene 3.0%

Principal Display Panel

BANANA BOAT®

SPORT

Ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 15

CLINICALLY

PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinozate

Water Resistant

(80 Minutes)

8 FL. OZ. (236mL)

Do Not Use

on damaged or broken skin

Active Ingredients

Avobenzone 2.0%, Homosalate 3.0%, Octisalate 4.5%, Octocrylene 3.0%

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

• 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 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 (Inactive ingredients)

Water, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Cetyl Dimethicone, Propylene Glycol, Phenoxyethanol, Caprylyl Glycol, VP/Eicosene Copolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Behenyl Alcohol, Sodium Polyacrylate, Chlorphenesin, Xanthan Gum, Disodium EDTA, Fragrance, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice

Principal Display Panel

BANANA BOAT®

SPORT

Ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 15

CLINICALLY

PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinozate

Water Resistant

(80 Minutes)

8 FL. OZ. (236mL)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients

Avobenzone 2.0%, Homosalate 3.0%, Octisalate 4.5%, Octocrylene 3.0%

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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