235a9430-b445-8d5c-e063-6394a90a9354

SPL v2
SPL
SPL Set ID 235a9430-b445-8d5c-e063-6394a90a9354
Route
topical
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (4.5 g) avobenzone (2.7 g) octocrylene (6.5 g) homosalate (9 g)
Inactive Ingredients
water edetate disodium sodium polyacrylate (2500000 mw) phenoxyethanol .alpha.-tocopherol acetate chlorphenesin xanthan gum glyceryl monostearate aloe vera leaf cetyl alcohol propylene glycol caprylyl glycol vinylpyrrolidone/eicosene copolymer peg-100 stearate docosanol

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2025-01-01 Until 2025-11-01

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

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50+

50+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

OXYBENZONE FREE

WATER RESISTANT

(80 MINUTES)

10 FL OZ (295 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, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Cetyl Dimethicone, Propylene Glycol, Phenoxyethanol, Caprylyl Glycol, VP/Eicosene Copolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Behenyl Alcohol, Sodium Polyacrylate, Chlorphenesin, Xanthan Gum, Disodium EDTA, Fragrance, 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 (PRINCIPAL DISPLAY PANEL)

BANANA

BOAT

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50+

50+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

OXYBENZONE FREE

WATER RESISTANT

(80 MINUTES)

10 FL OZ (295 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, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Cetyl Dimethicone, Propylene Glycol, Phenoxyethanol, Caprylyl Glycol, VP/Eicosene Copolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Behenyl Alcohol, Sodium Polyacrylate, Chlorphenesin, Xanthan Gum, Disodium EDTA, Fragrance, 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 If (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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