SPL v1
SPL
SPL Set ID 45089529-5811-5968-e063-6294a90a2e24
Route
TOPICAL
Published
Effective Date 2025-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (1 g) Octocrylene (3 g) Octisalate
Inactive Ingredients
Aqua Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

Description

Helps prevent sunburn. If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.


Medication Information

Warnings and Precautions

For external use only

Do not use

• on damaged or broken skin

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 swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Helps prevent sunburn.

If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration

• Apply liberally 15 minutes before sun exposure.

• Reapply at least every 2 hours.

• Use a water-resistant sunscreen if swimming or sweating.

• Children under 6 months of age: Ask a doctor.

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-sleeve shirts, pants, hats, and sunglasses.

Description

Helps prevent sunburn. If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

• 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

Section 51727-6

Water

Section 51945-4

Sunscreen SPF 50

Broad Spectrum

Water Resistant (80 minutes)

50 mL (1.69 fl oz)

Section 55105-1

Sunscreen

Helps prevent sunburn


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn.

If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

• Apply liberally 15 minutes before sun exposure.

• Reapply at least every 2 hours.

• Use a water-resistant sunscreen if swimming or sweating.

• Children under 6 months of age: Ask a doctor.

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-sleeve shirts, pants, hats, and sunglasses.

Warnings and Precautions (34071-1)

For external use only

Do not use

• on damaged or broken skin

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 swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

• 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

Section 51727-6 (51727-6)

Water

Section 51945-4 (51945-4)

Sunscreen SPF 50

Broad Spectrum

Water Resistant (80 minutes)

50 mL (1.69 fl oz)

Section 55105-1 (55105-1)

Sunscreen

Helps prevent sunburn


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)