SPL v4
SPL
SPL Set ID 22717885-d06b-ed2d-e063-6294a90a2118
Route
TOPICAL
Published
Effective Date 2025-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (5 g) Homosalate (7.5 g) Avobenzone (2.7 g) Octisalate (4.5 g)
Inactive Ingredients
Silicon Dioxide Phenoxyethanol Water Glyceryl Monostearate Sodium Polyacrylate (2500000 Mw) Glycerin Dimethicone Caprylyl Glycol Cetostearyl Alcohol Chlorphenesin Peg-100 Stearate Xanthan Gum Edetate Disodium .alpha.-tocopherol Acetate Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-01 Until 2027-10-01

Description

Avobenzone 2.7%, Homosalate 7.5%, Octisalate 4.5%, Octocrylene 5.0%.

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.7%, Homosalate 7.5%, Octisalate 4.5%, Octocrylene 5.0%.

Uses

• helps prevent sunburn • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.

Warnings

For external use only.

May stain some fabrics.

Directions

• Shake well • 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 J• children under 6 months: Ask a doctor

Do Not Use

• on damaged or broken skin.

Other Information

• protect the product in this container from excessive heat and direct sun

Active Ingredients

Avobenzone 2.7%, Homosalate 7.5%, Octisalate 4.5%, Octocrylene 5.0%.

Inactive Ingredients:

Water, Glycerin, Silica, Dimethicone, Phenoxyethanol, Caprylyl Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Cetearyl Alcohol, Sodium Polyacrylate, Chlorphenesin, PEG-100 Stearate, Glyceryl Stearate, Xanthan Gum, Fragrance, Disodium EDTA, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Questions Or Comments?

Call 1-800 SafeSun, Mon-Fri

Principal Display Panel

BONUS

25% MORE

10 OZ

VS

8 0Z

BANANA BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

OXYBENZONE FREE

WATER RESISTANT

10 FL. OZ. (295 mL)

BANANA BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

1 gal (128 FL. OZ.)

BANANA BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

8 FL. OZ. (236 mL)

50%

MORE

FAMILY SIZE!

12OZ

VS

8OZ

BANANA BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

12 FL OZ. (354 mL)

BANANA BOAT

New &

Improved

2 PACK

IMPROVED FORMULA

INSTANTLY

RUBS IN

ACROSS ALL SKIN TONES

SUPERIOR

PERFORMANCE

VS. SWEAT & WATER

WON'T RUN

INTO EYES

BANANA BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

2-10 FL.OZ (295 mL)

2 PACK LOTION

BANANA BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

2-8 FL.OZ (236 mL) TOTAL 16 FL. OZ. (472 mL)

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 aging caused by the sun.

Purpose

Sunscreen

Warnings

For external use only.

May stain some fabrics.

Directions

• Shake well • 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 J• children under 6 months: Ask a doctor

Do Not Use (Do not use)

• on damaged or broken skin.

Other Information (Other information)

• protect the product in this container from excessive heat and direct sun

Active Ingredients

Avobenzone 2.7%, Homosalate 7.5%, Octisalate 4.5%, Octocrylene 5.0%.

Inactive Ingredients:

Water, Glycerin, Silica, Dimethicone, Phenoxyethanol, Caprylyl Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Cetearyl Alcohol, Sodium Polyacrylate, Chlorphenesin, PEG-100 Stearate, Glyceryl Stearate, Xanthan Gum, Fragrance, Disodium EDTA, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Questions Or Comments? (Questions or comments?)

Call 1-800 SafeSun, Mon-Fri

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

BONUS

25% MORE

10 OZ

VS

8 0Z

BANANA BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

OXYBENZONE FREE

WATER RESISTANT

10 FL. OZ. (295 mL)

BANANA BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

1 gal (128 FL. OZ.)

BANANA BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

8 FL. OZ. (236 mL)

50%

MORE

FAMILY SIZE!

12OZ

VS

8OZ

BANANA BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

12 FL OZ. (354 mL)

BANANA BOAT

New &

Improved

2 PACK

IMPROVED FORMULA

INSTANTLY

RUBS IN

ACROSS ALL SKIN TONES

SUPERIOR

PERFORMANCE

VS. SWEAT & WATER

WON'T RUN

INTO EYES

BANANA BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

2-10 FL.OZ (295 mL)

2 PACK LOTION

BANANA BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

50

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

2-8 FL.OZ (236 mL) TOTAL 16 FL. OZ. (472 mL)

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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