Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a6b7ce85-cb3d-4c40-e053-2995a90a3bf2
Route
TOPICAL
Published
Effective Date 2020-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (20 mg) Octinoxate (65 mg) Octisalate (50 mg) Octocrylene (15 mg)
Inactive Ingredients
Petrolatum Ethylhexyl Palmitate Yellow Wax Paraffin Mineral Oil Ceresin Cetyl Alcohol Aloe .alpha.-tocopherol Acetate Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-01
Description

Avobenzone (2.0%) Octinoxate (6.5%) Octisalate (5.0%) Octocrylene (1.5%)

Medication Information

Warnings and Precautions

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product, keep out of eyes. Rinse with water to remove

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

Dosage and Administration

Apply liberally 15 min before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. 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 10am-2pm. Wear long sleeved shirts, pants, hats, and sunglasses.

Description

Avobenzone (2.0%) Octinoxate (6.5%) Octisalate (5.0%) Octocrylene (1.5%)

Section 51727-6

Mineral Oil, Beeswax, Petrolatum, Paraffin, Ethylhexyl Palmitate, Ceresin, Cetyl Alcohol, Toxopheryl Acetate, Propylparaben, Aloe Juice

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone (2.0%)

Octinoxate (6.5%)

Octisalate (5.0%)

Octocrylene (1.5%)

Section 60561-8

Protect this product from excessive heat and direct sun.

Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

Dosage and Administration (34068-7)

Apply liberally 15 min before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. 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 10am-2pm. Wear long sleeved shirts, pants, hats, and sunglasses.

Warnings and Precautions (34071-1)

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product, keep out of eyes. Rinse with water to remove

Keep out of reach of children

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

Section 51727-6 (51727-6)

Mineral Oil, Beeswax, Petrolatum, Paraffin, Ethylhexyl Palmitate, Ceresin, Cetyl Alcohol, Toxopheryl Acetate, Propylparaben, Aloe Juice

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone (2.0%)

Octinoxate (6.5%)

Octisalate (5.0%)

Octocrylene (1.5%)

Section 60561-8 (60561-8)

Protect this product from excessive heat and direct sun.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:50.809623 · Updated: 2026-03-14T22:57:08.393483