DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Octisalate (50 mg) Avobenzone (30 mg) Homosalate (77.4 mg) Octocrylene (100 mg)

Inactive Ingredients

Safflower Oil Pongamia Pinnata Seed Isododecane Butyloctyl Salicylate Diethylhexyl 2,6-naphthalate Oenocarpus Bataua Fruit Oil Titanium Dioxide Ferric Oxide Red Phenoxyethanol Magnesium Potassium Aluminosilicate Fluoride Alpha-tocopherol Acetate Ethylhexylglycerin Ethylhexyl Methoxycrylene Karum Seed Oil Mica Stannous Oxide Tocopherol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-03-27

Medication Information

Warnings and Precautions

Warnings:

• For extemal use only.

• Do not use on damaged or broken skin.

• When using this product keep our 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.

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 10am - 2pm.

• Wear long-sleeved shirts, pants, hats, and sunglasses.

Indications and Usage

Uses:

• Helps prevent sunburn.

Directions:

• Apply generously and evenly 15 minutes before sun exposure.

• Children under 6 months of age: ask a doctor.

• Reapply at least every 2 hours.

• Use a water-resistant sunscreen if swimming or sweating.

Dosage and Administration

Dosage: Evenly and generously apply to skin.

Administration: Topical

Description

Drug Facts Active Ingredients Purpose Avobenzone (3.00%)....Sunscreen Homosalate (7.34%).....Sunscreen Octisalate (5.00%)........Sunscreen Octocrylene (10.00%)..Sunscreen

Section 50565-1

Keep out of reach of children.

Section 51727-6

Butyloctyl Salicylate, Carthamus Tinctorius Seed Oil, Diethylhexyl 2,6-Naphthalate, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Iron Oxides (CI 77491), Isododecane, Maleated Soybean Oil Glyceryl/Octyldodecanol Esters, Mica (CI 77019), Oenocarpus Bataua Fruit Oil, Parfum (Fragrance), Phenoxyethanol, Pongamia Glabra Seed Oil, Pongamia Pinnata Seed Extract, Synthetic Fluorphlogopite, Tin Oxide (CI 77861), Titanium Dioxide (CI 77891), Tocopherol, Tocopheryl Acetate, Benzyl Salicylate, Citronellol, Limonene.

Section 51945-4

Section 53413-1

Questions or comments?

soldejaneiro.com

Section 55105-1

Sunscreen

Section 55106-9

Drug Facts

Active Ingredients Purpose

Avobenzone (3.00%)....Sunscreen

Homosalate (7.34%).....Sunscreen

Octisalate (5.00%)........Sunscreen

Octocrylene (10.00%)..Sunscreen

Structured Label Content

Indications and Usage (34067-9)

Uses:

• Helps prevent sunburn.

Directions:

• Apply generously and evenly 15 minutes before sun exposure.

• Children under 6 months of age: ask a doctor.

• Reapply at least every 2 hours.

• Use a water-resistant sunscreen if swimming or sweating.

Dosage and Administration (34068-7)

Dosage: Evenly and generously apply to skin.

Administration: Topical

Warnings and Precautions (34071-1)

Warnings:

• For extemal use only.

• Do not use on damaged or broken skin.

• When using this product keep our 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.

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 10am - 2pm.

• Wear long-sleeved shirts, pants, hats, and sunglasses.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Butyloctyl Salicylate, Carthamus Tinctorius Seed Oil, Diethylhexyl 2,6-Naphthalate, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Iron Oxides (CI 77491), Isododecane, Maleated Soybean Oil Glyceryl/Octyldodecanol Esters, Mica (CI 77019), Oenocarpus Bataua Fruit Oil, Parfum (Fragrance), Phenoxyethanol, Pongamia Glabra Seed Oil, Pongamia Pinnata Seed Extract, Synthetic Fluorphlogopite, Tin Oxide (CI 77861), Titanium Dioxide (CI 77891), Tocopherol, Tocopheryl Acetate, Benzyl Salicylate, Citronellol, Limonene.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

soldejaneiro.com

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Drug Facts

Active Ingredients Purpose

Avobenzone (3.00%)....Sunscreen

Homosalate (7.34%).....Sunscreen

Octisalate (5.00%)........Sunscreen

Octocrylene (10.00%)..Sunscreen

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses: • Helps prevent sunburn. Directions: • Apply generously and evenly 15 minutes before sun exposure. • Children under 6 months of age: ask a doctor. • Reapply at least every 2 hours. • Use a water-resistant sunscreen if swimming or sweating.", "34068-7": "Dosage: Evenly and generously apply to skin. Administration: Topical", "34071-1": "Warnings: • For extemal use only. • Do not use on damaged or broken skin. • When using this product keep our 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. 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 10am - 2pm. • Wear long-sleeved shirts, pants, hats, and sunglasses.", "50565-1": "Keep out of reach of children.", "51727-6": "Butyloctyl Salicylate, Carthamus Tinctorius Seed Oil, Diethylhexyl 2,6-Naphthalate, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Iron Oxides (CI 77491), Isododecane, Maleated Soybean Oil Glyceryl/Octyldodecanol Esters, Mica (CI 77019), Oenocarpus Bataua Fruit Oil, Parfum (Fragrance), Phenoxyethanol, Pongamia Glabra Seed Oil, Pongamia Pinnata Seed Extract, Synthetic Fluorphlogopite, Tin Oxide (CI 77861), Titanium Dioxide (CI 77891), Tocopherol, Tocopheryl Acetate, Benzyl Salicylate, Citronellol, Limonene.", "53413-1": "Questions or comments? soldejaneiro.com", "55105-1": "Sunscreen", "55106-9": "Drug Facts Active Ingredients Purpose Avobenzone (3.00%)....Sunscreen Homosalate (7.34%).....Sunscreen Octisalate (5.00%)........Sunscreen Octocrylene (10.00%)..Sunscreen"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information