Active Ingredient
Zinc Oxide 24.5%
Babo Botanicals Swim And Sport Mineral Sunscreen Balm Spf 50 Salve
FDA Label NDC 79265-8776
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Babo Botanicals, Inc. for the product Babo Botanicals Swim And Sport Mineral Sunscreen Balm Spf 50 (NDC 79265-8776). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask doctor, 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
Purpose
Sunscreen
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 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 two hours.
- Limit time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeve shirts, pants, hats and sunglasses.
- 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 of 15 or higher and other sun protection measures including:
Other Information
- Protect this product from excessive heat and direct sun.
- May stain some fabrics and surfaces.
Inactive Ingredients
Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Tapioca Starch, Saccharomyces Ferment, Behenyl Behenate, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Wax, Passiflora Edulis (Maracuja) Seed Oil, Bentonite, Butyrospermum Parkii (Shea) Butter, Tocopherol (Vitamin E), Helianthus Annuus (Sunflower) Seed Oil, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Nasturtium Officinale (Watercress) Flower/Leaf Extract, Spiraea Ulmaria (Meadowsweet) Flower Extract, Lauroyl Lysine, Euphorbia Cerifera (Candelilla) Wax, Acacia Decurrens Flower Wax, Polyglyceryl-10 Diisosterate, Polyglycerin-3.
Questions Or Comments?
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Product Packaging
2 (8776 2)
1 (8776 1)
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