dc757b03-7e7d-b362-e053-2a95a90a8446

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

Purpose

Sunscreen

Description

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


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

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

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)

Do Not Use

on damaged or broken skin.

Active Ingredients

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

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 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, 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 (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)

Do Not Use (Do not use)

on damaged or broken skin.

Active Ingredients

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

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

When Using This Product (When using this product)

keep out of eyes. 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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