Drug Facts

Composition & Product

Active Ingredients

Homosalate (5 mg) Ethylhexyl Salicylate (3 mg) Zinc Cation (21.372 mg) Titanium Dioxide (4.25 mg)

Inactive Ingredients

Mica Boron Nitride Zinc Stearate Dimethicone Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Silicon Dioxide Triethoxycaprylylsilane Red 7 Diisostearyl Malate Ethylhexylglycerin Yellow 5 Ultramarine Violet Silicon Caprylyl Glycol Tocopherol Brown Iron Oxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-01-30

Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 21.37% Homosalate 5.0% Titanium Dioxide 4.25% Ethylhexyl Salicylate 3.0%

Uses

● 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

Warnings

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 docor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally15 minutes before sun exposure and as needed

• reapply at least every 2 hours.

• use a water resistant sunscreen if swimming or sweating

• 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-sleeved shirts, pants, hats, and sunglasses

• children under 6 months of age: Ask a doctor

Questions?

1-866-860-0811

Other Information

Protect the product in this container from excessive heat and direct sun.

Active Ingredients

Zinc Oxide 21.37%

Homosalate 5.0%

Titanium Dioxide 4.25%

Ethylhexyl Salicylate 3.0%

Inactive Ingredients

Synthetic Fluorphlogopite, Mica, Boron Nitride, Zinc Stearate, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Triethoxycaprylylsilane, Diisostearyl Malate, Ethylhexylglycerin, Caprylyl Glycol, Tocopherol, Red 7 Lake (CI 15850), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Yellow 5 Lake (CI 19140), Ultramarines (CI 77007)

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children

Structured Label Content

Uses

● 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

Purpose

Sunscreen

Warnings

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 docor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally15 minutes before sun exposure and as needed

• reapply at least every 2 hours.

• use a water resistant sunscreen if swimming or sweating

• 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-sleeved shirts, pants, hats, and sunglasses

• children under 6 months of age: Ask a doctor

Questions?

1-866-860-0811

Other Information

Protect the product in this container from excessive heat and direct sun.

Active Ingredients

Zinc Oxide 21.37%

Homosalate 5.0%

Titanium Dioxide 4.25%

Ethylhexyl Salicylate 3.0%

Inactive Ingredients (Inactive ingredients)

Synthetic Fluorphlogopite, Mica, Boron Nitride, Zinc Stearate, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Triethoxycaprylylsilane, Diisostearyl Malate, Ethylhexylglycerin, Caprylyl Glycol, Tocopherol, Red 7 Lake (CI 15850), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Yellow 5 Lake (CI 19140), Ultramarines (CI 77007)

Principal Display Panel

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "● 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", "Purpose": "Sunscreen", "Warnings": "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 docor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Directions": "• apply liberally15 minutes before sun exposure and as needed • reapply at least every 2 hours. • use a water resistant sunscreen if swimming or sweating • 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-sleeved shirts, pants, hats, and sunglasses • children under 6 months of age: Ask a doctor", "Questions?": "1-866-860-0811", "Other Information": "Protect the product in this container from excessive heat and direct sun.", "Active Ingredients": "Zinc Oxide 21.37% Homosalate 5.0% Titanium Dioxide 4.25% Ethylhexyl Salicylate 3.0%", "Inactive ingredients": "Synthetic Fluorphlogopite, Mica, Boron Nitride, Zinc Stearate, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Triethoxycaprylylsilane, Diisostearyl Malate, Ethylhexylglycerin, Caprylyl Glycol, Tocopherol, Red 7 Lake (CI 15850), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Yellow 5 Lake (CI 19140), Ultramarines (CI 77007)", "Keep out of reach of children": "Keep out of reach of children"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information