Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum Spf 15 - Sandbar

Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum Spf 15 - Sandbar
SPL v4
SPL
SPL Set ID 3ac57c70-9298-cbe7-e063-6394a90aefc1
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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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