SPL v2
SPL
SPL Set ID 0c6aeadb-f61d-29e3-e063-6294a90a7473
Route
TOPICAL
Published
Effective Date 2023-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (7.5 g) Avobenzone (3 g) Homosalate (9 g)
Inactive Ingredients
Water Phenethyl Benzoate Carbomer Homopolymer, Unspecified Type Xanthan Gum Sodium Hydroxide Ethylhexylglycerin Chlorphenesin Glycerin Dimethicone Peg-20 Methyl Glucose Sesquistearate Phenoxyethanol Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01 Until 2027-10-01

Description

Avobenzone 3.0%, Homosalate 9.0%, Octocrylene 7.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 9.0%, Octocrylene 7.5%

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.

Section 51945-4

BANANA

BOAT®

KiDS

SPORT

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PROTECTS

FROM 98%

OF BURNING RAYS

won’t run into eyes

Water Resistant

(80 Minutes)

6 FL. OZ. (177 mL)

BONUS

25% MORE

7.5 OZ

VS

6 OZ

BANANA

BOAT®

KiDS

SPORT

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PROTECTS

FROM 98%

OF BURNING RAYS

won’t run into eyes

Water Resistant

(80 Minutes)

7.5 FL. OZ. (221.8 mL)

50% MORE

FAMILY SIZE!

9 OZ VS 6 OZ

BANANA

BOAT®

KiDS

SPORT

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PROTECTS

FROM 98%

OF BURNING RAYS

won’t run into eyes

Water Resistant

(80 Minutes)

9 FL. OZ. (266 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 3.0%, Homosalate 9.0%, Octocrylene 7.5%

Inactive Ingredients

Water, Phenethyl Benzoate, Glycerin, Dimethicone, PEG-20 Methyl Glucose Sesquistearate, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Carbomer, Ethylhexylglycerin, Chlorphenesin, Sodium Hydroxide, Xanthan Gum, Disodium EDTA.

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®

KiDS

SPORT

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PROTECTS

FROM 98%

OF BURNING RAYS

won’t run into eyes

Water Resistant

(80 Minutes)

6 FL. OZ. (177 mL)

BONUS

25% MORE

7.5 OZ

VS

6 OZ

BANANA

BOAT®

KiDS

SPORT

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PROTECTS

FROM 98%

OF BURNING RAYS

won’t run into eyes

Water Resistant

(80 Minutes)

7.5 FL. OZ. (221.8 mL)

50% MORE

FAMILY SIZE!

9 OZ VS 6 OZ

BANANA

BOAT®

KiDS

SPORT

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

PROTECTS

FROM 98%

OF BURNING RAYS

won’t run into eyes

Water Resistant

(80 Minutes)

9 FL. OZ. (266 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 3.0%, Homosalate 9.0%, Octocrylene 7.5%

Inactive Ingredients

Water, Phenethyl Benzoate, Glycerin, Dimethicone, PEG-20 Methyl Glucose Sesquistearate, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Carbomer, Ethylhexylglycerin, Chlorphenesin, Sodium Hydroxide, Xanthan Gum, Disodium EDTA.

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 If (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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