SPL v4
SPL
SPL Set ID a8ea16dc-055a-43e9-e053-2a95a90a33c5
Route
TOPICAL
Published
Effective Date 2020-06-26
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
Water Chlorphenesin Cetyl Dimethicone 150 Phenoxyethanol Vinylpyrrolidone/eicosene Copolymer Caprylyl Glycol Cetyl Alcohol Sodium Polyacrylate (8000 Mw) Glyceryl 1-stearate Xanthan Gum Edetate Disodium Anhydrous .alpha.-tocopherol Acetate Aloe Vera Leaf Propylene Glycol Docosanol Peg-100 Stearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-26 Until 2026-10-01

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 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

Primary Display Panel

BANANA

BOAT®

SPORT

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

30

CLINICALLY

PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

1 FL. OZ. (29mL)

BANANA

BOAT®

SPORT

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

30

CLINICALLY

PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

3 FL. OZ. (88mL)

BANANA

BOAT®

SPORT

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

30

CLINICALLY

PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

8 FL. OZ. (236mL)

BONUS

25% MORE

10 OZ

VS

8 OZ

BANANA

BOAT®

SPORT

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

30

CLINICALLY

PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

10 FL. OZ. (295mL)

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

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 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 (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

Primary Display Panel

BANANA

BOAT®

SPORT

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

30

CLINICALLY

PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

1 FL. OZ. (29mL)

BANANA

BOAT®

SPORT

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

30

CLINICALLY

PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

3 FL. OZ. (88mL)

BANANA

BOAT®

SPORT

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

30

CLINICALLY

PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

8 FL. OZ. (236mL)

BONUS

25% MORE

10 OZ

VS

8 OZ

BANANA

BOAT®

SPORT

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

30

CLINICALLY

PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

10 FL. OZ. (295mL)

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.


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