Otc - Active Ingredient
Zinc Oxide 12% - Sunscreen
Burts Bees Spf 30 Untinted Lip Balm Coco Loco Stick
FDA Label NDC 51514-0371
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Autumn Harp for the product Burts Bees Spf 30 Untinted Lip Balm Coco Loco (NDC 51514-0371). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, dosage & administration, other safety information, inactive ingredient, otc - questions, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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 product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & 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.
Other Safety Information
Protect this product from excessive heat and direct sun.
Inactive Ingredient
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.
Otc - Questions
1-800-849-7112 or www.burtsbees.com
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away
Indications & 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.
* Please review the disclaimer below.
