e313350f-74d9-370b-e053-2995a90aeeaf

SPL v2
SPL
SPL Set ID e313350f-74d9-370b-e053-2995a90aeeaf
Route
topical
Published
Effective Date 2022-07-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) homosalate (10 g) octisalate (15 g)
Inactive Ingredients
eicosyl povidone ceresin polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) alkyl (c12-15) benzoate medium-chain triglycerides c15-19 alkane octocrylene ethylhexyl palmitate paraffin aloe vera leaf butylated hydroxytoluene cetyl alcohol sunflower oil cocoa butter

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-07-05

Description

Sunscreen.


Medication Information

Warnings and Precautions

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.

Active Ingredient

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%.

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. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.

Sun Protection Measures. Spending time in the sun increased your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am - 2 pm, wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months: ask a doctor.

Description

Sunscreen.

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Aloe Barbadensis Leaf Extract, BHT, Caprylic/Capric Triglyceride, Cetyl Alcohol, C12-15 Alkyl Benzoate, C15-19 Alkane, Ethylhexyl Palmitate, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Ozokerite, Paraffin, Polyester-8, Theobroma Cacao (Cocoa) Seed Butter, VP/Eicosene Copolymer.

Section 51945-4

Section 55105-1

Sunscreen.


Structured Label Content

Warnings and Precautions (34071-1)

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.

Active Ingredient (55106-9)

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%.

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. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.

Sun Protection Measures. Spending time in the sun increased your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am - 2 pm, wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months: ask a doctor.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Aloe Barbadensis Leaf Extract, BHT, Caprylic/Capric Triglyceride, Cetyl Alcohol, C12-15 Alkyl Benzoate, C15-19 Alkane, Ethylhexyl Palmitate, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Ozokerite, Paraffin, Polyester-8, Theobroma Cacao (Cocoa) Seed Butter, VP/Eicosene Copolymer.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen.


Advanced Ingredient Data


Raw Label Data

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