SPL v7
SPL
SPL Set ID 05cb5a91-205f-b652-e063-6294a90a0664
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) Octocrylene (7 g) Octisalate (4.5 g)
Inactive Ingredients
Caprylyl Glycol Water Alcohol Mineral Oil Panthenol Medium-chain Triglycerides Alpha-tocopherol Acetate Dimethicone Isododecane Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-01

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

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

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.

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

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 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, Tocopheryl Acetate, Mineral Oil, Panthenol, Water, Aloe Barbadensis Leaf Extract

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA BOAT(R)

KiDS

360 COVERAGE

advanced control mist

BROAD SPECTRUM SPF 50+ SUNSCREEN

50+

won't run into eyes

Water Resistant

(80 Minutes)

Aerosol Free*

5.5 FL. OZ. (162 mL)

AEROSOL-FREE REFILL AEROSOL-FREE

BANANA BOAT(R)

KiDS

360 COVERAGE

advanced control mist

BROAD SPECTRUM SPF 50+ SUNSCREEN

50+

won't run into eyes

Water Resistant

(80 Minutes)

5.5 FL. OZ. (162 mL)

STARTER PACK 1 SPRAYER + 1 REFILL

BANANA BOAT(R)

BUNDLE AND SAVE

KiDS

360 COVERAGE

advanced control mist

BROAD SPECTRUM SPF 50+ SUNSCREEN

50+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

won't run into eyes

Water Resistant

(80 Minutes)

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

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

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. 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.

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

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 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, Tocopheryl Acetate, Mineral Oil, Panthenol, Water, Aloe Barbadensis Leaf Extract

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA BOAT(R)

KiDS

360 COVERAGE

advanced control mist

BROAD SPECTRUM SPF 50+ SUNSCREEN

50+

won't run into eyes

Water Resistant

(80 Minutes)

Aerosol Free*

5.5 FL. OZ. (162 mL)

AEROSOL-FREE REFILL AEROSOL-FREE

BANANA BOAT(R)

KiDS

360 COVERAGE

advanced control mist

BROAD SPECTRUM SPF 50+ SUNSCREEN

50+

won't run into eyes

Water Resistant

(80 Minutes)

5.5 FL. OZ. (162 mL)

STARTER PACK 1 SPRAYER + 1 REFILL

BANANA BOAT(R)

BUNDLE AND SAVE

KiDS

360 COVERAGE

advanced control mist

BROAD SPECTRUM SPF 50+ SUNSCREEN

50+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

won't run into eyes

Water Resistant

(80 Minutes)

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

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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