05ce5223-3fb2-4c27-e063-6394a90a8a8f

SPL v7
SPL
SPL Set ID 05ce5223-3fb2-4c27-e063-6394a90a8a8f
Route
topical
Published
Effective Date 2023-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (9 g) avobenzone (2.7 g) octisalate (4.5 g) octocrylene (7 g)
Inactive Ingredients
mineral oil alcohol caprylyl glycol medium-chain triglycerides alpha-tocopherol acetate dimethicone water isododecane aloe vera leaf panthenol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-10-01 Until 2027-10-01

Purpose

Sunscreen

Description

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 7.0%.


Medication Information

Warnings

For external use only, Flammable: Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

May stain some fabrics and surfaces.

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

• Hold container 4 to 6 inches from the skin to apply. Don’t spray directly into face. Apply on hand then apply to face. Spray evenly and liberally on your skin. Use in a well-ventilated area. Apply 15 minutes before sun exposure. Reapply throughout the day • at least every 2 hours, • after 80 minutes of swimming or sweating • immediately after towel drying • 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
Description

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 7.0%.

Principal Display Panel

BANANA BOAT(R)

SPORT(TM)

360 COVERAGE

advanced control mist

BROAD SPECTRUM SPF 50+ SUNSCREEN

50+

Sweat | Water Resistant

(80 Minutes)

Aerosol Free*

5.5 FL. OZ. (162 mL)

AEROSOL-FREE REFILL AEROSOL-FREE

BANANA BOAT(R)

SPORT(TM)

360 COVERAGE

advanced control mist

BROAD SPECTRUM SPF 50+ SUNSCREEN

50+

Sweat | Water Resistant

(80 Minutes)

5.5 FL. OZ. (162 mL)

STARTER PACK 1 SPRAYER + 1 REFILL

BANANA BOAT(R)

BUNDLE AND SAVE

SPORT(TM)

360 COVERAGE

advanced control mist

BROAD SPECTRUM SPF 50+ SUNSCREEN

50+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Water Resistant

(80 Minutes)

2 - 5.5 FL.OZ. (162 mL) Bottles – Total Net Wt. 11 FL.OZ. (324 mL)

Do Not Use

on damaged or broken skin.

Active Ingredients

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 7.0%.

Inactive Ingredients:

Alcohol Denat., Caprylic/Capric Triglyceride, Isododecane, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone, Fragrance, Tocopheryl Acetate, Mineral Oil, Water, Panthenol, Aloe Barbadensis Leaf Extract.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

When Using This Product

Keep away from face to avoid breathing it • Keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs

Keep Out of Reach of Children,

ESPECIALLY WHEN REFILLING PRODUCT. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.


Structured Label Content

Warnings

For external use only, Flammable: Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

May stain some fabrics and surfaces.

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

• Hold container 4 to 6 inches from the skin to apply. Don’t spray directly into face. Apply on hand then apply to face. Spray evenly and liberally on your skin. Use in a well-ventilated area. Apply 15 minutes before sun exposure. Reapply throughout the day • at least every 2 hours, • after 80 minutes of swimming or sweating • immediately after towel drying • 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
Principal Display Panel

BANANA BOAT(R)

SPORT(TM)

360 COVERAGE

advanced control mist

BROAD SPECTRUM SPF 50+ SUNSCREEN

50+

Sweat | Water Resistant

(80 Minutes)

Aerosol Free*

5.5 FL. OZ. (162 mL)

AEROSOL-FREE REFILL AEROSOL-FREE

BANANA BOAT(R)

SPORT(TM)

360 COVERAGE

advanced control mist

BROAD SPECTRUM SPF 50+ SUNSCREEN

50+

Sweat | Water Resistant

(80 Minutes)

5.5 FL. OZ. (162 mL)

STARTER PACK 1 SPRAYER + 1 REFILL

BANANA BOAT(R)

BUNDLE AND SAVE

SPORT(TM)

360 COVERAGE

advanced control mist

BROAD SPECTRUM SPF 50+ SUNSCREEN

50+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Water Resistant

(80 Minutes)

2 - 5.5 FL.OZ. (162 mL) Bottles – Total Net Wt. 11 FL.OZ. (324 mL)

Do Not Use (Do not use)

on damaged or broken skin.

Active Ingredients

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 7.0%.

Inactive Ingredients:

Alcohol Denat., Caprylic/Capric Triglyceride, Isododecane, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone, Fragrance, Tocopheryl Acetate, Mineral Oil, Water, Panthenol, Aloe Barbadensis Leaf Extract.

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

When Using This Product (When using this product)

Keep away from face to avoid breathing it • 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,)

ESPECIALLY WHEN REFILLING PRODUCT. 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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