Burts Bees Spf 30 Untinted Lip Balms

Burts Bees Spf 30 Untinted Lip Balms
SPL v1
SPL
SPL Set ID 1ac89261-eeae-567c-e063-6294a90ad45f
Route
TOPICAL
Published
Effective Date 2024-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (11.99 g)
Inactive Ingredients
Almond Oil Candelilla Wax Isostearic Acid Castor Oil White Wax Argan Oil Soybean Oil Carnauba Wax Polyglyceryl-3 Ricinoleate Shea Butter .alpha.-tocopherol Acetate, Dl- Pongamia Pinnata Seed Glyceryl 1-undecylenate Jojoba Oil Fragrance 13576 Glyceryl Caprylate .alpha.-bisabolol, (+/-)- Medium-chain Triglycerides .alpha.-tocopherol, Dl- Polyhydroxystearic Acid (2300 Mw) Lecithin, Sunflower .alpha.-amylcinnamaldehyde Limonene, (+/-)- Linalool, (+/-)- Orange Oil Clove Oil Nutmeg Oil Hydroxycitronellal Turmeric Oil Lavender Oil Eugenol Benzyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-01

Description

Zinc Oxide 12% - Sunscreen


Medication Information

Warnings and Precautions

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

Indications and Usage

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

For sunscreen use:

- Apply liberally 15 minutes before sun exposure.

- Use a water-resistant sunscreen if swimming or sweating.

- Reapply at least every 2 hours.



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 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.

- children under 6 months: Ask a doctor.

Description

Zinc Oxide 12% - Sunscreen

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

Beaches and Cream - Inactive Ingredients: Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Argania Spinosa Kernel Oil, Euphorbia Cerifera (Candelilla) Wax, Ricinus Communis (Castor) Seed Oil, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Polyhydroxystearic Acid, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Glyceryl Caprylate, Natural Fragrance, Tocopherol, Pongamia pinnata seed extract, Bisabolol, Glycine Soja (Soybean) Oil, Glyceryl Undecylenate.

Tropic Like It's Hot - Inactive Ingredients: Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Argania Spinosa Kernel Oil, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Polyhydroxystearic Acid, Natural Fragrance, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Glyceryl Caprylate, Tocopherol, Pongamia pinnata seed extract, Bisabolol, Glycine Soja (Soybean) Oil, Orange Oil Terpenes, Limonene, Linalool, Glyceryl Undecylenate, Amyl Cinnamal.

Coco Loco - Inactive Ingredients: Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Argania Spinosa Kernel Oil, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Polyhydroxystearic Acid, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Glyceryl Caprylate, Tocopherol, Citrus Aurantium Dulcis (Orange) Peel Oil, Eugenia Caryophyllus (Clove) Bud Oil, Lavandula Angustifolia (Lavender) Oil, Ricinus Communis (Castor) Seed Oil, Curcuma Longa (Turmeric) Root Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Natural Fragrance, Pongamia pinnata seed extract, Bisabolol, Glycine Soja (Soybean) Oil, Limonene, Glyceryl Undecylenate, Amyl Cinnamal, Benzyl Salicylate, Hydroxycitronellal, Eugenol, Linalool.

Section 51945-4

Section 53413-1

1-800-849-7112 or www.burtsbees.com

Section 55105-1

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 55106-9

Zinc Oxide 12% - Sunscreen

Section 60561-8

Protect this product from excessive heat and direct sun.


Structured Label Content

Indications and Usage (34067-9)

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)

For sunscreen use:

- Apply liberally 15 minutes before sun exposure.

- Use a water-resistant sunscreen if swimming or sweating.

- Reapply at least every 2 hours.



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 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.

- children under 6 months: Ask a doctor.

Warnings and Precautions (34071-1)

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

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)

Beaches and Cream - Inactive Ingredients: Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Argania Spinosa Kernel Oil, Euphorbia Cerifera (Candelilla) Wax, Ricinus Communis (Castor) Seed Oil, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Polyhydroxystearic Acid, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Glyceryl Caprylate, Natural Fragrance, Tocopherol, Pongamia pinnata seed extract, Bisabolol, Glycine Soja (Soybean) Oil, Glyceryl Undecylenate.

Tropic Like It's Hot - Inactive Ingredients: Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Argania Spinosa Kernel Oil, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Polyhydroxystearic Acid, Natural Fragrance, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Glyceryl Caprylate, Tocopherol, Pongamia pinnata seed extract, Bisabolol, Glycine Soja (Soybean) Oil, Orange Oil Terpenes, Limonene, Linalool, Glyceryl Undecylenate, Amyl Cinnamal.

Coco Loco - Inactive Ingredients: Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Argania Spinosa Kernel Oil, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Polyhydroxystearic Acid, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Glyceryl Caprylate, Tocopherol, Citrus Aurantium Dulcis (Orange) Peel Oil, Eugenia Caryophyllus (Clove) Bud Oil, Lavandula Angustifolia (Lavender) Oil, Ricinus Communis (Castor) Seed Oil, Curcuma Longa (Turmeric) Root Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Natural Fragrance, Pongamia pinnata seed extract, Bisabolol, Glycine Soja (Soybean) Oil, Limonene, Glyceryl Undecylenate, Amyl Cinnamal, Benzyl Salicylate, Hydroxycitronellal, Eugenol, Linalool.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-800-849-7112 or www.burtsbees.com

Section 55105-1 (55105-1)

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 55106-9 (55106-9)

Zinc Oxide 12% - Sunscreen

Section 60561-8 (60561-8)

Protect this product from excessive heat and direct sun.


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