203c9d86-45d7-efcc-e063-6394a90acefb

SPL v2
SPL
SPL Set ID 203c9d86-45d7-efcc-e063-6394a90acefb
Route
topical
Published
Effective Date 2024-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (4 g) octisalate (3 g) octocrylene (2 g) avobenzone
Inactive Ingredients
dimethicone silicon dioxide cetostearyl alcohol peg-100 stearate glyceryl monostearate glycerin sodium polyacrylate (2500000 mw) water phenoxyethanol caprylyl glycol xanthan gum edetate disodium aloe vera leaf chlorphenesin .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-02-01 Until 2027-10-01

Purpose

Sunscreen

Description

Avobenzone 2.0%, Homosalate 4.0% Octisalate 4.0%, Octocrylene 3.0


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



• 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 • children under 6 months: Ask a doctor

Other Information

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

Description

Avobenzone 2.0%, Homosalate 4.0% Octisalate 4.0%, Octocrylene 3.0

Principal Display Panel

BANANA

BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

30

PROTECTS

FROM UP TO 97%

OF BURNING RAYS

OXYBENZONE FREE

Sweat | Water Resistant

(80 Minutes)

0.4 FL OZ (11 mL)

BANANA

BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

30

PROTECTS

FROM UP TO 97%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

8 FL OZ (236 mL)

BANANA

BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

30

PROTECTS

FROM UP TO 97%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

1.0 FL OZ (29 mL)

BANANA

BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

30

PROTECTS

FROM UP TO 97%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

3 FL OZ (88 mL)

Do Not Use

• on damaged or broken skin.

Active Ingredients

Avobenzone 2.0%, Homosalate 4.0% Octisalate 4.0%, Octocrylene 3.0

Inactive Ingrdients



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

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



• 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 • children under 6 months: Ask a doctor

Other Information

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

Principal Display Panel

BANANA

BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

30

PROTECTS

FROM UP TO 97%

OF BURNING RAYS

OXYBENZONE FREE

Sweat | Water Resistant

(80 Minutes)

0.4 FL OZ (11 mL)

BANANA

BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

30

PROTECTS

FROM UP TO 97%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

8 FL OZ (236 mL)

BANANA

BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

30

PROTECTS

FROM UP TO 97%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

1.0 FL OZ (29 mL)

BANANA

BOAT

New &

Improved

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

30

PROTECTS

FROM UP TO 97%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

3 FL OZ (88 mL)

Do Not Use (Do not use)

• on damaged or broken skin.

Active Ingredients

Avobenzone 2.0%, Homosalate 4.0% Octisalate 4.0%, Octocrylene 3.0

Inactive Ingrdients



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

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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