Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum Spf 15 - Sunset Cove Carded

Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum Spf 15 - Sunset Cove Carded
SPL v2
SPL
SPL Set ID 3ac67c26-d56e-32a9-e063-6294a90a1048
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (50 mg) Octocrylene (30 mg) Homosalate (100 mg) Zinc Oxide (29 mg)
Inactive Ingredients
Tocopherol Caprylic/capric Triglyceride Olea Europaea (olive) Fruit Oil Euphorbia Cerifera (candelilla) Wax Tin Oxide Theobroma Grandiflorum Seed Butter Limnanthes Alba (meadowfoam) Seed Oil Hydrolyzed Jojoba Esters Carthamus Tinctorius (safflower) Seed Oil Mica Ferric Oxide Red Simmondsia Chinensis (jojoba) Seed Oil Butyrospermum Parkii (shea) Butter Titanium Dioxide Red 7 Octyldodecyl Oleate Helianthus Annuus (sunflower) Seed Oil Silica Beeswax Ricinus Communis (castor) Seed Oil Cocos Nucifera (coconut) Oil Stevia Rebaudiana Leaf Aluminum Hydroxide Polyhydroxystearic Acid (2300 Mw) Aloe Barbadensis Leaf Copernicia Cerifera (carnauba) Wax Polymethylsilsesquioxane (4.5 Microns) Soybean Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Homosalate 10%, Octisalate 5%, Octocrylene 3%, Zinc Oxide 2.9%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 10%, Octisalate 5%, Octocrylene 3%, Zinc Oxide 2.9%

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

Warnings

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• apply liberally 15 minutes before sun exposure

• reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • 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 sun protection measures including:

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

• wear long-sleeved shirts, pants, hats and sunglasses

Questions?

1-877-978-6286

Primary Artwork

Other Information

protect this product from excessive heat and direct sun

Active Ingredients

Homosalate 10%, Octisalate 5%, Octocrylene 3%, Zinc Oxide 2.9%

Inactive Ingredients

Beeswax, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Ricinus Communis (Castor) Seed Oil, Caprylic/Capric Triglyceride, Olea Europaea (Olive) Fruit Oil, Theobroma Grandiflorum Seed Butter, Copernicia Cerifera (Carnauba) Wax, Titanium Dioxide, Polymethylsilsesquioxane, Euphorbia Cerifera (Candelilla) Wax, Flavor, Iron Oxides, Mica, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Stevia Rebaudiana Extract, Glycine Soja (Soybean) Oil, Jojoba Esters, Limnanthes Alba (Meadowfoam) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Polyhydroxystearic Acid, Octyldodecyl Oleate, Tocopherol, Aluminum Hydroxide, Silica, Tin Oxide, Red 7 Lake


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

Purpose

Sunscreen

Warnings

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• apply liberally 15 minutes before sun exposure

• reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • 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 sun protection measures including:

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

• wear long-sleeved shirts, pants, hats and sunglasses

Questions?

1-877-978-6286

Primary Artwork

Other Information

protect this product from excessive heat and direct sun

Active Ingredients

Homosalate 10%, Octisalate 5%, Octocrylene 3%, Zinc Oxide 2.9%

Inactive Ingredients

Beeswax, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Ricinus Communis (Castor) Seed Oil, Caprylic/Capric Triglyceride, Olea Europaea (Olive) Fruit Oil, Theobroma Grandiflorum Seed Butter, Copernicia Cerifera (Carnauba) Wax, Titanium Dioxide, Polymethylsilsesquioxane, Euphorbia Cerifera (Candelilla) Wax, Flavor, Iron Oxides, Mica, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Stevia Rebaudiana Extract, Glycine Soja (Soybean) Oil, Jojoba Esters, Limnanthes Alba (Meadowfoam) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Polyhydroxystearic Acid, Octyldodecyl Oleate, Tocopherol, Aluminum Hydroxide, Silica, Tin Oxide, Red 7 Lake


Advanced Ingredient Data


Raw Label Data

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