Active Ingredient
Zinc Oxide 19.7%
Babo Botanicals Sensitive Baby Mineral Sunscreen Spf50 Stick
FDA Label NDC 79265-5608
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 Sensitive Baby Mineral Sunscreen Spf50 (NDC 79265-5608). 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 a 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 A Doctor
if rash occurs
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control center right away.
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
- 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 protection measures including:
- 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: ask a doctor
Other Information
- Protect this product from excessive heat and direct sun.
- May stain some fabrics and surfaces.
Inactive Ingredients
Oryza Sativa (Rice) Bran Oil*, Persea Gratissima (Avocado) Oil*, Euphorbia Cerifera (Candelilla) Wax, Octyldodecyl Oleate, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Theobroma Cacao (Cocoa) Seed Butter*, Oryzanol, Butyrospermum Parkii (Shea) Butter*, Jojoba Esters, 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*, Bisabolol*, Calophyllum Inophyllum (Tamanu) Seed Oil*, Tocopherol.
*Certified Organic Ingredients
Company Information
Dist: by Babo Botanicals, Inc.
60 East 56th Street New York, NY 10022
Package Labeling
1 (8065)
* Please review the disclaimer below.
