2bc94923-b221-5159-e063-6394a90ab8ff

SPL v1
SPL
SPL Set ID 2bc94923-b221-5159-e063-6394a90ab8ff
Route
topical
Published
Effective Date 2025-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (10 g) octisalate (5 g) octocrylene (3 g) avobenzone
Inactive Ingredients
polyglyceryl-6 stearate ethylhexyl methoxycrylene water butylene glycol niacinamide butyloctyl salicylate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-01-02

Description

Active ingredient(s) Homosalate 10.0% Octocrylene 10.0% Ethylhexyl Salicylate 5.0% Avobenzone 3.0%


Medication Information

Warnings and Precautions

Warning

- 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 irritation or rash occurs.

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

Active Ingredient

Active ingredient(s)



Homosalate 10.0%

Octocrylene 10.0%

Ethylhexyl Salicylate 5.0%

Avobenzone 3.0%

Indications and Usage

Use(s)

- 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

Directions

- Apply liberally 15 minutes before sun exposure.

- Reapply at least every 2 hours.

- Use a water-resistant sunscreen if swimming or sweating

- 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 SPF value of 15 or higher and other sun protection measures including:

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

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

Description

Active ingredient(s) Homosalate 10.0% Octocrylene 10.0% Ethylhexyl Salicylate 5.0% Avobenzone 3.0%

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 51727-6

Inactive ingredients

Water, Butylene Glycol, Butyloctyl Salicylate, Polyglyceryl-6 Stearate, Ethylhexyl Methoxycrylene, Niacinamide, Poly C10-30 Alkyl Acrylate, Sorbitan Sesquioleate, Silica, Behenyl Alcohol, 1,2-Hexanediol, Hydroxyacetophenone, Sodium Polyacryloyldimethyl Taurate, Polyglyceryl-6 Behenate, Polyacrylate Crosspolymer-6, Sphingomonas Ferment Extract, Tocopheryl Acetate, Panthenol, Disodium EDTA, Adenosine, Centella Asiatica Extract, Monarda Didyma Leaf Extract, Mentha Piperita Leaf Extract, Lavandula Angustifolia Flower Extract, Freesia Refracta Extract, Rosmarinus Officinalis Leaf Extract, Chamomilla Recutita Flower Extract, Asiaticoside, Caprylyl Glycol, Madecassoside, Madecassic Acid, Asiatic Acid

Section 51945-4

Section 53413-1

Questions

www.lookatmecos.com

Section 55105-1

Purpose

Sunscreen

Section 60561-8

Other Information

-Protect the product in this container from excessive heat and direct sun


Structured Label Content

Warnings and Precautions (34071-1)

Warning

- 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 irritation or rash occurs.

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

Active Ingredient (55106-9)

Active ingredient(s)



Homosalate 10.0%

Octocrylene 10.0%

Ethylhexyl Salicylate 5.0%

Avobenzone 3.0%

Indications and Usage (34067-9)

Use(s)

- 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)

Directions

- Apply liberally 15 minutes before sun exposure.

- Reapply at least every 2 hours.

- Use a water-resistant sunscreen if swimming or sweating

- 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 SPF value of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10a.m.-2p.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 51727-6 (51727-6)

Inactive ingredients

Water, Butylene Glycol, Butyloctyl Salicylate, Polyglyceryl-6 Stearate, Ethylhexyl Methoxycrylene, Niacinamide, Poly C10-30 Alkyl Acrylate, Sorbitan Sesquioleate, Silica, Behenyl Alcohol, 1,2-Hexanediol, Hydroxyacetophenone, Sodium Polyacryloyldimethyl Taurate, Polyglyceryl-6 Behenate, Polyacrylate Crosspolymer-6, Sphingomonas Ferment Extract, Tocopheryl Acetate, Panthenol, Disodium EDTA, Adenosine, Centella Asiatica Extract, Monarda Didyma Leaf Extract, Mentha Piperita Leaf Extract, Lavandula Angustifolia Flower Extract, Freesia Refracta Extract, Rosmarinus Officinalis Leaf Extract, Chamomilla Recutita Flower Extract, Asiaticoside, Caprylyl Glycol, Madecassoside, Madecassic Acid, Asiatic Acid

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions

www.lookatmecos.com

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 60561-8 (60561-8)

Other Information

-Protect the product in this container from excessive heat and direct sun


Advanced Ingredient Data


Raw Label Data

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