SPL v1
SPL
SPL Set ID 3c414e9b-6c3e-2c8d-e063-6394a90af4a6
Route
TOPICAL
Published
Effective Date 2025-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.5 g) Octocrylene (7.5 g) Oxybenzone (3.5 g)
Inactive Ingredients
Lauryl Peg-8 Dimethicone (300 Cps) Hydrogenated Polyisobutene 8 Hydrated Silica Polyethylene Chlorphenesin Phenoxyethanol Dimethicone Edetate Disodium Isohexadecane Ethylhexyl Palmitate Microcrystalline Wax Aloe Barbadensis Leaf Powder Water Sodium Chloride Ascorbyl Palmitate Butyloctyl Salicylate Beeswax Caprylyl Glycol .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-31

Description

Avobenzone 2.5%, Octocrylene 7.5%, Oxybenzone 3.5% .

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.5%, Octocrylene 7.5%, Oxybenzone 3.5% .

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.

May stain some fabrics.

Directions

■ 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

Do Not Use

■ on damaged or broken skin.

Active Ingredient

Avobenzone 2.5%, Octocrylene 7.5%, Oxybenzone 3.5% .

Other Information

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

Inactive Ingredients

Water, Hydrogenated Polyisobutene, Lauryl PEG-8 Dimethicone, Butyloctyl Salicylate, Ethylhexyl Palmitate, Dimethicone, Hydrated Silica, Sodium Chloride, Phenoxyethanol, Beeswax, Acrylates/ C12-22 Alkyl Methacrylate Copolymer, Isohexadecane, Microcrystalline Wax, Polyethylene, Chlorphenesin, Caprylyl Glycol, Disodium EDTA, Stearoxy Dimethicone, Tocopheryl Acetate, Ascorbyl Palmitate, Aloe Barbadensis Leaf Juice Powder.

Questions Or Comments?



Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA

BOAT

SPORT

ULTRA

SUNSCREEN LOTION

BROAD SPECTRUM SPF 100

100

CLINICALLY PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

WATER RESISTANT

(80 Minutes)

4 FL. OZ. (118 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 skin aging caused by the sun.

Purpose

Sunscreen

Warnings

For external use only.

May stain some fabrics.

Directions

■ 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

Do Not Use (Do not use)

■ on damaged or broken skin.

Active Ingredient

Avobenzone 2.5%, Octocrylene 7.5%, Oxybenzone 3.5% .

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Water, Hydrogenated Polyisobutene, Lauryl PEG-8 Dimethicone, Butyloctyl Salicylate, Ethylhexyl Palmitate, Dimethicone, Hydrated Silica, Sodium Chloride, Phenoxyethanol, Beeswax, Acrylates/ C12-22 Alkyl Methacrylate Copolymer, Isohexadecane, Microcrystalline Wax, Polyethylene, Chlorphenesin, Caprylyl Glycol, Disodium EDTA, Stearoxy Dimethicone, Tocopheryl Acetate, Ascorbyl Palmitate, Aloe Barbadensis Leaf Juice Powder.

Questions Or Comments? (Questions or Comments?)



Call 1-800-SafeSun, Mon-Fri

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

BANANA

BOAT

SPORT

ULTRA

SUNSCREEN LOTION

BROAD SPECTRUM SPF 100

100

CLINICALLY PROVEN

UVA/UVB PROTECTION

SUPERIOR ENDURANCE

VS. SWEAT & WATER

WATER RESISTANT

(80 Minutes)

4 FL. OZ. (118 mL)

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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