Drug Facts
Drug Facts enclosed
Babo Botanicals Hydrating Milk Mineral Sunscreen Spf 30 Lotion
FDA Label NDC 79265-8164
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 Hydrating Milk Mineral Sunscreen Spf 30 (NDC 79265-8164). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Zinc Oxide 17%
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
- Shake well
- Apply liberally 15 minutes before sun exposure
- Reapply after 40 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
Water (Aqua), Caprylic/Capric Triglyceride, C13-15 Alkane, Coco-Caprylate/Caprate, Polyglyceryl-6 Polyricinoleate, Propanediol, Stearyl/Octyldodecyl Citrate Crosspolymer, Polyhydroxystearic Acid, Polyglyceryl-10 Dioleate, Sodium Chloride, Passiflora Edulis (Maracuja) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Caprylhydroxamic Acid, Xanthan Gum, 1,2-Hexanediol.
*CERTIFIED ORGANIC INGREDIENTS
Questions Or Comments?
Call 1-800-422-2987 M-F 9:00AM - 5:00PM EST
Product Labeling
1 (79265 8164 0)
* Please review the disclaimer below.
