Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID afd10abe-1e8b-4df8-9d8c-ef15266c510c
Route
TOPICAL
Published
Effective Date 2023-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (122 mg) Homosalate (170 mg) Octinoxate (30 mg) Octisalate (75 mg) Petrolatum (50 mg)
Inactive Ingredients
Light Mineral Oil Ceresin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-01
Description

Avobenzone 3.0%, Homosalate 3.0%, Octinoxate 7.5%, Octisalate 5.0%................Sunscreen, Petrolatum 40.0%...........Skin Protectant

Purpose

Sunscreen, Skin Protectant

Medication Information

Purpose

Sunscreen, Skin Protectant

Description

Avobenzone 3.0%, Homosalate 3.0%, Octinoxate 7.5%, Octisalate 5.0%................Sunscreen, Petrolatum 40.0%...........Skin Protectant

Uses

Prevents Sunburns. Helps prevent wind burned and chapped 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 to prevent sunburn, skin cancer and/or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

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 the risk, regularly use a sunscreen with a broad spectrum

SPF 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. Children under 6 months: Ask a doctor.

Active Ingredient

Avobenzone 3.0%, Homosalate 3.0%, Octinoxate 7.5%, Octisalate 5.0%................Sunscreen, Petrolatum 40.0%...........Skin Protectant

Inactive Ingredients

C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Mineral Oil, Ozokerite, Phenyl Trimethicone, Tocopherol

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

Prevents Sunburns. Helps prevent wind burned and chapped 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 to prevent sunburn, skin cancer and/or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

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 the risk, regularly use a sunscreen with a broad spectrum

SPF 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. Children under 6 months: Ask a doctor.

Active Ingredient (Active ingredient)

Avobenzone 3.0%, Homosalate 3.0%, Octinoxate 7.5%, Octisalate 5.0%................Sunscreen, Petrolatum 40.0%...........Skin Protectant

Inactive Ingredients

C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Mineral Oil, Ozokerite, Phenyl Trimethicone, Tocopherol

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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:56.224922 · Updated: 2026-03-14T23:08:25.015175