Drug Facts

Composition & Product

Active Ingredients

Avobenzone (122 mg) Homosalate (170 mg) Octinoxate (30 mg) Octocrylene (82 mg) Dimethicone 100 (75 mg)

Inactive Ingredients

Light Mineral Oil Ceresin

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-12-01

Medication Information

Purpose

Sunscreen, Skin Protectant

Description

Avobenzone 3.0%, Homosalate 8.2%, Octinoxate 7.5%, Octocrylenene7.0%................Sunscreen, Dimethicone 2.0.0%...........Skin Protectant

Uses

Helps prevent sunburns. Helps prevent and temporarily protect 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 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 8.2%, Octinoxate 7.5%, Octocrylenene7.0%................Sunscreen, Dimethicone 2.0.0%...........Skin Protectant

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Euphorbia Cerifera (Candellila) Wax, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Lanolin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Menthol, Microcrystalline Wax, Mineral Oil, Ozokerite, Petrolatum, Phenyl Trimethicone, Retinyl Palmitate, Synthetic Beeswax, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate.

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 sunburns. Helps prevent and temporarily protect 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 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 8.2%, Octinoxate 7.5%, Octocrylenene7.0%................Sunscreen, Dimethicone 2.0.0%...........Skin Protectant

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Euphorbia Cerifera (Candellila) Wax, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Lanolin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Menthol, Microcrystalline Wax, Mineral Oil, Ozokerite, Petrolatum, Phenyl Trimethicone, Retinyl Palmitate, Synthetic Beeswax, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate.

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": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "122", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CERESIN", "unii": "Q1LS2UJO3A", "classCode": "IACT", "strengthNumerator": "170", "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": "82", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "DIMETHICONE 100", "unii": "RO266O364U", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent sunburns. Helps prevent and temporarily protect 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 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 8.2%, Octinoxate 7.5%, Octocrylenene7.0%................Sunscreen, Dimethicone 2.0.0%...........Skin Protectant", "Inactive Ingredients": "Aloe Barbadensis Leaf Extract, Euphorbia Cerifera (Candellila) Wax, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Lanolin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Menthol, Microcrystalline Wax, Mineral Oil, Ozokerite, Petrolatum, Phenyl Trimethicone, Retinyl Palmitate, Synthetic Beeswax, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate.", "Keep Out of Reach of Children": "If swallowed get medical help or contact a Poison Control Center right away."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information