22e2b447-bd6b-5e8a-e063-6394a90a0de9

SPL v1
SPL
SPL Set ID 22e2b447-bd6b-5e8a-e063-6394a90a0de9
Route
topical
Published
Effective Date 2025-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (9 g) octisalate (4.5 g) octocrylene (6.5 g) avobenzone (2.7 g)
Inactive Ingredients
dimethicone chlorphenesin .alpha.-tocopherol acetate cetostearyl alcohol glyceryl monostearate aloe vera leaf edetate disodium water glycerin peg-100 stearate silicon dioxide phenoxyethanol xanthan gum caprylyl glycol sodium polyacrylate (2500000 mw)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-02-01

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

Principal Display Panel

BANANA

BOAT

NEW &

IMPROVED

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 60+

60+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

8 FL.OZ. (236 mL)

Do Not Use

• on damaged or broken skin.

Active Ingredients

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

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

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 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 60+

60+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

Oxybenzone Free

Sweat | Water Resistant

(80 Minutes)

8 FL.OZ. (236 mL)

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%

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

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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