breath fresh spf 15 lip balm

breath fresh spf 15 lip balm
SPL v3
SPL
SPL Set ID a0c3a62f-5c11-c78c-e053-2a95a90a3a58
Route
topical
Published
Effective Date 2020-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (0.21 g) avobenzone (0.09 g) octocrylene (0.06 g) octinoxate (0.28 g)
Inactive Ingredients
soybean oil canola oil sunflower oil mono/diglycerides stevia leaf peppermint sunflower oil tocopherol rosemary white wax olive oil cannabis sativa seed oil aloe vera leaf spearmint oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-02-17

Purpose

Sunscreen

Description

Avobenzone 2.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%


Medication Information

Warnings

For external use only

Indications and Usage

Helps prevent sunburn

Purpose

Sunscreen

Dosage and Administration

Apply liberally 15 minutes before sun exposure

Directions

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

Children under 6 months of age: Ask a doctor

Description

Avobenzone 2.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%

Do Not Use

on damaged or broken skin.

Package Label

Active Ingredients

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Inactive Ingredients:

Sunflower Oil*, Beeswax, Olive Oil*, Peppermint Oil, Spearmint Oil, Hemp Seed Oil*, Rosemary Extract, Tocopherol, Soybean Oil, Sunflower Seed Oil Glycerides, Aloe Extract, Stevia*, Canola Oil. * Organic

When Using This Product

Keep out of eyes. Rinse well with water to remove.

Stop Use and Ask A Doctor If

Rash Occurs

Keep Out of Reach of Children

Keep out of reach of children.

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


Structured Label Content

Warnings

For external use only

Indications and Usage (34067-9)

Helps prevent sunburn

Purpose

Sunscreen

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure

Directions

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

Children under 6 months of age: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin.

Package Label

Active Ingredients

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Inactive Ingredients: (Inactive ingredients:)

Sunflower Oil*, Beeswax, Olive Oil*, Peppermint Oil, Spearmint Oil, Hemp Seed Oil*, Rosemary Extract, Tocopherol, Soybean Oil, Sunflower Seed Oil Glycerides, Aloe Extract, Stevia*, Canola Oil. * Organic

When Using This Product (When Using this Product)

Keep out of eyes. Rinse well with water to remove.

Stop Use and Ask A Doctor If (Stop Use and ask a doctor if)

Rash Occurs

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.

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


Advanced Ingredient Data


Raw Label Data

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