SPL v1
SPL
SPL Set ID 1d4cab02-8897-6449-e063-6294a90ad72e
Route
TOPICAL
Published
Effective Date 2024-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (4 g) Avobenzone (2.7 g) Octisalate (5 g) Octocrylene
Inactive Ingredients
Peg-100 Stearate Aloe Vera Leaf Water Sodium Polyacrylate (2500000 Mw) Glyceryl Monostearate Isohexadecane Edetate Disodium Glycerin Silicon Dioxide Dimethicone Phenoxyethanol Caprylyl Glycol Ceramide Np .alpha.-tocopherol Acetate Chlorphenesin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-01

Description

Avobenzone 2.7%, Homosalate 4.0%, Octisalate 4.0%, Octocrylene 5.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.7%, Homosalate 4.0%, Octisalate 4.0%, Octocrylene 5.0%

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.

Section 51945-4

BANANA BOAT

SPORT

face

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50

50

INSTANTLY

RUBS IN CLEAR

Won't Clog Pores

Sweat | Water Resistant (80 Minutes)

3 FL. OZ. (89 mL)

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 4.0%, Octisalate 4.0%, Octocrylene 5.0%

Inactive Ingredients

Water, Glycerin, Silica, Dimethicone, Isohexadecane, Phenoxyethanol, Caprylyl Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Sodium Polyacrylate, Chlorphenesin, Disodium EDTA, Glyceryl Stearate, PEG-100 Stearate, Ceramide NP, 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.

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.

Section 51945-4 (51945-4)

BANANA BOAT

SPORT

face

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50

50

INSTANTLY

RUBS IN CLEAR

Won't Clog Pores

Sweat | Water Resistant (80 Minutes)

3 FL. OZ. (89 mL)

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 4.0%, Octisalate 4.0%, Octocrylene 5.0%

Inactive Ingredients

Water, Glycerin, Silica, Dimethicone, Isohexadecane, Phenoxyethanol, Caprylyl Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Sodium Polyacrylate, Chlorphenesin, Disodium EDTA, Glyceryl Stearate, PEG-100 Stearate, Ceramide NP, 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.

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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