SPL v1
SPL
SPL Set ID 18e7fc6b-b40a-f790-e063-6294a90ad0f4
Route
TOPICAL
Published
Effective Date 2024-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (1.5 g) Avobenzone (0.9 g) Octocrylene (2.4 g) Homosalate (3 g)
Inactive Ingredients
Glycerin Soybean Oil Aloe Vera Leaf Potassium Sorbate Tocopherol Water Cetearyl Glucoside Cetostearyl Alcohol Grape Seed Oil Sunflower Oil Xanthan Gum Pentylene Glycol Almond Oil Anhydrous Citric Acid Benzyl Alcohol Glyceryl Stearate Se Propanediol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-20

Description

Active Ingredients: Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 8%


Medication Information

Warnings and Precautions

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove.

Indications and Usage

Helps prevent sunburn

Dosage and Administration

Apply liberally 15 minutes before sun exposure

Reapply after 80 minutes of swimming or sweating.

Reapply immediately after towel drying.

Reapply at least every 2 hours

Children under 6 months of age: 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 sunprotection measures including:

limit time in the sun, especially from 10a.m.-2p.m.

wear long sleeved shirts, pants, hats and sunglasses.

Description

Active Ingredients: Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 8%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Section 51727-6

Aloe Juice, Benzyl Alcohol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Fragrance, Glycerin, Glyceryl Stearate SE, Grapeseed Oil, Pentylene Glycol, Potassium Sorbate, Propanediol, Soybean Oil, Sunflower Oil, Sweet Almond Oil, Tocopherol, Water, Xanthan Gum.

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Active Ingredients:

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 8%

Section 60561-8

Protect this product from excessive heat and direct sun.


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure

Reapply after 80 minutes of swimming or sweating.

Reapply immediately after towel drying.

Reapply at least every 2 hours

Children under 6 months of age: 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 sunprotection measures including:

limit time in the sun, especially from 10a.m.-2p.m.

wear long sleeved shirts, pants, hats and sunglasses.

Warnings and Precautions (34071-1)

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Section 51727-6 (51727-6)

Aloe Juice, Benzyl Alcohol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Fragrance, Glycerin, Glyceryl Stearate SE, Grapeseed Oil, Pentylene Glycol, Potassium Sorbate, Propanediol, Soybean Oil, Sunflower Oil, Sweet Almond Oil, Tocopherol, Water, Xanthan Gum.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients:

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 8%

Section 60561-8 (60561-8)

Protect this product from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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