Other
This is a sunscreen manufactured according the sunscreen final monograph. Active ingredients Zinc oxide and Titanium Dioxide
Babo Spf 30 Sheer Zinc Sunscreen
FDA Label NDC 79265-8097
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 Spf 30 Sheer Zinc Sunscreen (NDC 79265-8097). 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 other, active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient(S)
Titanium Dioxide 4.65%
Zinc Oxide 15.0%
Purpose
Sunscreen
Use
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 a product is swallowed get medical help or contact a Poison Control center right away.
Do Not Use
- on damaged or broken skin.
Otc - When Using
Keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Directions• Apply liberally to exposed areas 15 minutes before sun exposure. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-drying
Other Information
- Protect this product from excessive heat and direct sun
Inactive Ingredients
Aloe Barbadensis Leaf Juice
Bentonite
Butyloctyl Salicylate
Calendula Officinalis Flower Extract*
Caprylhydroxamic Acid
Caprylyl Glycol
Carthamus Tinctorius (Safflower) Seed Oil
Cetearyl Alcohol
Chamomilla Recutita (Matricaria) Flower Extract*
Coco Glucoside
Glycerin
Helianthus Annuus (Sunflower) Seed Oil
Heptyl Undecylenate
Jojoba Esters
Methyl Dihydroabietate
Nasturtium Officinale (Watercress) Flower/leaf Extract*
Pueraria Lobata (Kudzu) Root Extract*
Spiraea Ulmaria (Meadowsweet) Flower Extract*
Water (Aqua)
*Certified Organic Ingredient
Package Label - Principal Display Panel
6 fl.oz. 177 ml NDC: 79265-8097-6
* Please review the disclaimer below.
