SPL v4
SPL
SPL Set ID cd270b6c-e673-3429-e053-2995a90af140
Route
TOPICAL
Published
Effective Date 2021-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.7 g) Octocrylene (6.5 g) Homosalate (13.5 g) Octisalate (4.5 g)
Inactive Ingredients
Glyceryl 1-stearate Cetyl Alcohol Propylene Glycol Caprylyl Glycol Chlorphenesin Peg-100 Stearate Ethylhexyl Methoxycrylene Xanthan Gum Water Vinylpyrrolidone/eicosene Copolymer Sodium Polyacrylate (2500000 Mw) Phenoxyethanol Edetate Disodium Aloe Vera Leaf Alpha-tocopherol Acetate Docosanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-15 Until 2026-10-01

Description

Avobenzone 2.7%, Homosalate 13.5%, Octisalate 4.5%, Octocrylene 6.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.7%, Homosalate 13.5%, Octisalate 4.5%, Octocrylene 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

Avobenzone 2.7%, Homosalate 13.5%, Octisalate 4.5%, Octocrylene 6.5%

Inactive Ingredients

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

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

When Using This Product

keep out of eyes. Rinse with water to remove.

Princlipal Display Panel

BANANA

BOAT®

SPORT

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 65

65

CLINICALLY

PROVEN

UVA/UVB PROTECTION

HIGH ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

8 FL. OZ. (236mL)

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

Avobenzone 2.7%, Homosalate 13.5%, Octisalate 4.5%, Octocrylene 6.5%

Inactive Ingredients

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

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.

Princlipal Display Panel

BANANA

BOAT®

SPORT

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 65

65

CLINICALLY

PROVEN

UVA/UVB PROTECTION

HIGH ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

8 FL. OZ. (236mL)

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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