DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Homosalate (4.5 g) Octisalate (2.7 g) Titanium Dioxide (1.32 g) Zinc Cation (7.62 g)

Inactive Ingredients

Water Cyclomethicone 5 Dipropylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-06-01

Medication Information

Indications and Usage

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

Other Information:

Protect this product from excessive heat and direct sun

Purpose

Sunscreen

Dosage and Administration

Directions:

• Apply liberally 15 minutes before sun exposure

• Reapply at least every 2 hours

• Use a water-resistant sunscreen if swimming or sweating

• 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

HOMOSALATE 7.50% OCTISALATE 4.50% TITANIUM DIOXIDE 2.20% ZINC OXIDE 12.70%

Section 50565-1

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

Section 51945-4

Warnings

For external use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif rash occurs

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

Active Ingredients

HOMOSALATE 7.50%

OCTISALATE 4.50%

TITANIUM DIOXIDE 2.20%

ZINC OXIDE 12.70%

Inactive Ingredients

Aqua/Water/Eau, Cyclopentasiloxane, Dipropylene Glycol, Disiloxane, Lauryl Peg-10 Tris(Trimethylsiloxy)Silylethyl Dimethicone, Glycerin, Niacinamide, Propylheptyl Caprylate, Portulaca Oleracea Extract, Silica, Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Dicaprylyl Carbonate, 1,2-Hexanediol, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Synthetic Fluorphlogopite, Triethoxycaprylylsilane, Aluminum Hydroxide, Stearic Acid, Sorbitan Caprylate, Dimethicone/Peg-10/15 Crosspolymer, Fragrance(Parfum), Iron Oxides(CI 77492), Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Ethylhexylglycerin, Adenosine, Iron Oxides(CI 77491), Iron Oxides(CI 77499), Tocopherol, Camellia Sinensis Leaf Extract, Melissa Officinalis Extract, Centella Asiatica Extract, Perilla Ocymoides Leaf Extract

Structured Label Content

Indications and Usage (34067-9)

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

Other Information:

Protect this product from excessive heat and direct sun

Dosage and Administration (34068-7)

Directions:

• Apply liberally 15 minutes before sun exposure

• Reapply at least every 2 hours

• Use a water-resistant sunscreen if swimming or sweating

• 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

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Sunscreen

Warnings (WARNINGS)

For external use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif rash occurs

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

Active Ingredients (ACTIVE INGREDIENTS)

HOMOSALATE 7.50%

OCTISALATE 4.50%

TITANIUM DIOXIDE 2.20%

ZINC OXIDE 12.70%

Inactive Ingredients (INACTIVE INGREDIENTS)

Aqua/Water/Eau, Cyclopentasiloxane, Dipropylene Glycol, Disiloxane, Lauryl Peg-10 Tris(Trimethylsiloxy)Silylethyl Dimethicone, Glycerin, Niacinamide, Propylheptyl Caprylate, Portulaca Oleracea Extract, Silica, Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Dicaprylyl Carbonate, 1,2-Hexanediol, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Synthetic Fluorphlogopite, Triethoxycaprylylsilane, Aluminum Hydroxide, Stearic Acid, Sorbitan Caprylate, Dimethicone/Peg-10/15 Crosspolymer, Fragrance(Parfum), Iron Oxides(CI 77492), Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Ethylhexylglycerin, Adenosine, Iron Oxides(CI 77491), Iron Oxides(CI 77499), Tocopherol, Camellia Sinensis Leaf Extract, Melissa Officinalis Extract, Centella Asiatica Extract, Perilla Ocymoides Leaf Extract

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CYCLOMETHICONE 5", "unii": "0THT5PCI0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPROPYLENE GLYCOL", "unii": "E107L85C40", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "4.5", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "2.7", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "1.32", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ZINC CATION", "unii": "13S1S8SF37", "classCode": "ACTIM", "strengthNumerator": "7.62", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "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 Other Information: Protect this product from excessive heat and direct sun", "34068-7": "Directions: • Apply liberally 15 minutes before sun exposure • Reapply at least every 2 hours • Use a water-resistant sunscreen if swimming or sweating • 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", "50565-1": "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.", "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 doctor if rash occurs Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center right away.", "ACTIVE INGREDIENTS": "HOMOSALATE 7.50% OCTISALATE 4.50% TITANIUM DIOXIDE 2.20% ZINC OXIDE 12.70%", "INACTIVE INGREDIENTS": "Aqua/Water/Eau, Cyclopentasiloxane, Dipropylene Glycol, Disiloxane, Lauryl Peg-10 Tris(Trimethylsiloxy)Silylethyl Dimethicone, Glycerin, Niacinamide, Propylheptyl Caprylate, Portulaca Oleracea Extract, Silica, Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Dicaprylyl Carbonate, 1,2-Hexanediol, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Synthetic Fluorphlogopite, Triethoxycaprylylsilane, Aluminum Hydroxide, Stearic Acid, Sorbitan Caprylate, Dimethicone/Peg-10/15 Crosspolymer, Fragrance(Parfum), Iron Oxides(CI 77492), Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Ethylhexylglycerin, Adenosine, Iron Oxides(CI 77491), Iron Oxides(CI 77499), Tocopherol, Camellia Sinensis Leaf Extract, Melissa Officinalis Extract, Centella Asiatica Extract, Perilla Ocymoides Leaf Extract"}