5407 Sunscreen

5407 Sunscreen
SPL v2
SPL
SPL Set ID f3f86164-2a2e-4f1f-a562-c1ff6cf50322
Route
TOPICAL
Published
Effective Date 2023-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octocrylene (5 g) Octisalate
Inactive Ingredients
Water Glycerin Medium-chain Triglycerides Potassium Cetyl Phosphate Cetostearyl Alcohol Dimethicone Caprylyl Glycol Phenoxyethanol Glyceryl Monostearate Vinylpyrrolidone/hexadecene Copolymer Levomenol Carbomer Homopolymer, Unspecified Type Trolamine Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-31

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

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.

Section 42229-5

Broad Spectrum SPF30 Sunscreen Lotion

Made in China

For Innovation Line

Culver City, CA 90230

Section 50565-1

Keep out of Reach of Children.If swallowed, get medical help or contact a Poison Control Center right away.

Purpose:

Sunscreen

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.

Packaging

Directions

•Apply liberally 15 minutes exposure. •reapply: •after 40 minutes of swimming or sweating •immediately after towel drying •at least every 2 hours.

Sun Protection Measure. 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 of 15 higher and other sun protection measures including: •limit time in the sun, especially from 10 a.m.-2 p.m. •wear long-sleeve shirts, pants, hats and sunglasses •children under 6 months: Ask a doctor.

Drug Facts

Other Information

•Protect this product from excessive heat and direct sun

Active Ingredients

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

Inactive Ingredients

Water, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA

Questions Or Comments?

Call:1-855-755-5346


Structured Label Content

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.

Section 42229-5 (42229-5)

Broad Spectrum SPF30 Sunscreen Lotion

Made in China

For Innovation Line

Culver City, CA 90230

Section 50565-1 (50565-1)

Keep out of Reach of Children.If swallowed, get medical help or contact a Poison Control Center right away.

Purpose:

Sunscreen

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.

Packaging

Directions

•Apply liberally 15 minutes exposure. •reapply: •after 40 minutes of swimming or sweating •immediately after towel drying •at least every 2 hours.

Sun Protection Measure. 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 of 15 higher and other sun protection measures including: •limit time in the sun, especially from 10 a.m.-2 p.m. •wear long-sleeve shirts, pants, hats and sunglasses •children under 6 months: Ask a doctor.

Drug Facts

Other Information (Other information)

•Protect this product from excessive heat and direct sun

Active Ingredients

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

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA

Questions Or Comments? (Questions or Comments?)

Call:1-855-755-5346


Advanced Ingredient Data


Raw Label Data

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