Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID 32725ca7-ec21-4643-bdc6-278fd647b95d

Route

TOPICAL

Published

Effective Date 2024-07-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Petrolatum (165 mg) Avobenzone (120 mg) Homosalate (23 mg) Octisalate (396 mg)

Inactive Ingredients

Ceresin Caprylic/capric/lauric Triglyceride Isocetyl Stearate

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-07-15

Description

Avobenzone, Homosalate, Octisalate, Petrolatum

Purpose

Sunscreen, Skin Protectant

Medication Information

Purpose

Sunscreen, Skin Protectant

Description

Avobenzone, Homosalate, Octisalate, Petrolatum

Uses

Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.

For external use only

Stop use and ask a doctor: If rash or irritation develops and lasts.

Directions

Apply liberally before sun exposure and as needed.

Children under 6 months of age: Ask a doctor before use.

Active Ingredient

Avobenzone, Homosalate, Octisalate, Petrolatum

Keep Out of Reach of Children

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

Package/label Principal Display Panel

Structured Label Content

Uses

Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.

Purpose

Sunscreen, Skin Protectant

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.

For external use only

Stop use and ask a doctor: If rash or irritation develops and lasts.

Directions

Apply liberally before sun exposure and as needed.

Children under 6 months of age: Ask a doctor before use.

Active Ingredient (Active ingredient)

Avobenzone, Homosalate, Octisalate, Petrolatum

Keep Out of Reach of Children

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data

[{"name": "CERESIN", "unii": "Q1LS2UJO3A", "classCode": "IACT", "strengthNumerator": "165", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE", "unii": "FJ1H6M2JG9", "classCode": "IACT", "strengthNumerator": "120", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ISOCETYL STEARATE", "unii": "3RJ7186O9W", "classCode": "IACT", "strengthNumerator": "23", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "396", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.", "Purpose": "Sunscreen, Skin Protectant", "Warnings": "Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging. For external use only Stop use and ask a doctor: If rash or irritation develops and lasts.", "Directions": "Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.", "Active ingredient": "Avobenzone, Homosalate, Octisalate, Petrolatum", "Keep Out of Reach of Children": "If swallowed get medical help or contact a Poison Control Center right away."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:20.330992 · Updated: 2026-03-14T23:12:32.924893