DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Titanium Dioxide (80 mg) Zinc Oxide (38 mg)

Inactive Ingredients

Dimethiconol (2000 Cst) Ci 77492 Tetrahexyldecyl Ascorbate Cyclopentasiloxane Ci 77499 Lauryl Peg/ppg-18/18 Methicone Alumina Hydrogen Dimethicone (20 Cst) Cyclohexasiloxane Dimethicone Dimethicone Crosspolymer Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Ci 77491 Peg-10 Dimethicone (600 Cst) Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-09-24

Medication Information

Warnings and Precautions

For external use only. Do not use on broken or damaged 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. 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.

Dosage and Administration

Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: 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 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.

Description

Titanium Dioxide 8% Zinc Oxide 3.8%

Section 50565-1

Keep out of reach of children

Section 51727-6

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Titanium Dioxide 8%

Zinc Oxide 3.8%

Section 60561-8

Protect this product from excessive heat and direct sun
May stain some fabrics
PA+++

Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: 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 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.

Warnings and Precautions (34071-1)

For external use only. Do not use on broken or damaged 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 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Titanium Dioxide 8%

Zinc Oxide 3.8%

Section 60561-8 (60561-8)

Protect this product from excessive heat and direct sun
May stain some fabrics
PA+++

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "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.", "34068-7": "Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: 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 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.", "34071-1": "For external use only. Do not use on broken or damaged 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.", "50565-1": "Keep out of reach of children", "51727-6": "Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate", "55105-1": "Sunscreen", "55106-9": "Titanium Dioxide 8% Zinc Oxide 3.8%", "60561-8": "Protect this product from excessive heat and direct sun May stain some fabrics PA+++"}