97b5aba8-3ba8-1c93-e053-2a95a90a3f57

SPL v6
SPL
SPL Set ID 97b5aba8-3ba8-1c93-e053-2a95a90a3f57
Route
topical
Published
Effective Date 2019-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (6.5 g) avobenzone (2.7 g) homosalate (9 g) octisalate (4.5 g)
Inactive Ingredients
caprylyl glycol chlorphenesin phenoxyethanol vinylpyrrolidone/eicosene copolymer xanthan gum edetate disodium anhydrous aloe vera leaf glyceryl monostearate cetyl alcohol propylene glycol docosanol peg-100 stearate water .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-11-19 Until 2026-10-01

Purpose

Sunscreen

Description

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.5%


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 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 9.0%, Octisalate 4.5%, Octocrylene 6.5%

Principal Display Panel

BANANA

BOAT®

SPORT™

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50+

CLINICALLY PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

2 FL. OZ. (59mL)

BANANA

BOAT®

SPORT™

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50+

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 50+

CLINICALLY PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

10 FL. OZ. (295mL)

50%

MORE

FAMILY SIZE!

12 OZ

VS

8 OZ

BANANA

BOAT®

SPORT

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50+

CLINICALLY PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

12 FL. OZ. (354mL)

BANANA

BOAT®

SPORT

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50+

CLINICALLY PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

Breathable Formula

Water Resistant

(80 Minutes)

1 gal (3.78L)

May Stain

some fabrics

Do Not Use

on damaged or broken skin

Active Ingredients

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.5%

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 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 (Other information)

• protect this product from excessive heat and direct sun

Inactive Ingredients (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

BANANA

BOAT®

SPORT™

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50+

CLINICALLY PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

2 FL. OZ. (59mL)

BANANA

BOAT®

SPORT™

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50+

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 50+

CLINICALLY PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

10 FL. OZ. (295mL)

50%

MORE

FAMILY SIZE!

12 OZ

VS

8 OZ

BANANA

BOAT®

SPORT

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50+

CLINICALLY PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

FREE FROM

Oxybenzone

Octinoxate

Water Resistant

(80 Minutes)

12 FL. OZ. (354mL)

BANANA

BOAT®

SPORT

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50+

CLINICALLY PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

Breathable Formula

Water Resistant

(80 Minutes)

1 gal (3.78L)

May Stain (May stain)

some fabrics

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.5%

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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