SPL v3
SPL
SPL Set ID dc757b03-7e7d-b362-e053-2a95a90a8446
Route
TOPICAL
Published
Effective Date 2022-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (4.5 g) Octocrylene (2.7 g) Avobenzone (6 g) Homosalate
Inactive Ingredients
Glyceryl Monostearate Cetyl Alcohol Edetic Acid .alpha.-tocopherol Acetate Aloe Vera Leaf Water Peg-100 Stearate Phenoxyethanol Caprylyl Glycol Benzyl Alcohol Sodium Polyacrylate (2500000 Mw) Chlorphenesin Propylene Glycol Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-04-12 Until 2026-12-01

Description

Avobenzone 2.7%, Homosalate 6.0%, Octisalate 4.5%, Octocrylene 4.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.7%, Homosalate 6.0%, Octisalate 4.5%, Octocrylene 4.5%

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

• 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 6.0%, Octisalate 4.5%, Octocrylene 4.5%

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.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA

BOAT®

Sport

ultra

faces

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 30

30

OIL FREE, NON-GREASY

UVA/UVB PROTECTION

FREE FROM

Oxybenzene

Octinoxate

Water Resistant

(80 Minutes)

3 FL.OZ (88 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

• 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 6.0%, Octisalate 4.5%, Octocrylene 4.5%

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.

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

BANANA

BOAT®

Sport

ultra

faces

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 30

30

OIL FREE, NON-GREASY

UVA/UVB PROTECTION

FREE FROM

Oxybenzene

Octinoxate

Water Resistant

(80 Minutes)

3 FL.OZ (88 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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